Belinda R. Mori, N.P.; Decision and Order, 36582-36591 [2013-14447]
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Federal Register / Vol. 78, No. 117 / Tuesday, June 18, 2013 / Notices
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[OMB Number 1117–0052]
Agency Information Collection
Activities; Proposed Collection;
Comments Requested; Extension With
Change of a Previously Approved
Collection: National Drug Threat
Survey
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ACTION:
30-Day Notice.
The United States Department of
Justice (DOJ), Drug Enforcement
Administration (DEA), will be
submitting the following information
collection request to the Office of
Management and Budget (OMB) for
review and approval in accordance with
the Paperwork Reduction Act of 1995.
The proposed information collection is
published to obtain comments from the
public and affected agencies. This
proposed information collection was
previously published in the Federal
Register Volume 78, Number 64, page
20141 on April 3, 2013, allowing for a
60 day comment period.
The purpose of this notice is to allow
for an additional 30 days for public
comment until July 18, 2013. This
process is conducted in accordance with
5 CFR 1320.10.
If you have comments especially on
the estimated public burden and
associated response time, suggestions,
or need a copy of the proposed
information collection instrument with
instructions or additional information,
please contact Richard L. Nagy, Unit
Chief, Domestic Strategic Intelligence
Unit, Office of Intelligence, Warning,
Plans and Programs, Drug Enforcement
Administration, 8701 Morrissette Drive,
Springfield, VA 22152.
Written comments and suggestions
from the public and affected agencies
concerning the proposed collection of
information are encouraged. Your
comments should address one or more
of the following four points:
• Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency whether the
information will have practical utility;
• Evaluate the accuracy of the
agencies’ estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
• Enhance the quality, utility, and
clarity of the information to be
collected; and
• Minimize the burden of the
collection of information on those who
are to respond, including through the
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use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submission of
responses.
Overview of This Information
Collection 1117–0052
(1) Type of Information Collection:
Extension of a currently approved
collection.
(2) Title of the Form/Collection:
National Drug Threat Survey.
(3) Agency form number, if any, and
the applicable component of the
Department sponsoring the collection:
Form number: None.
Component: Intelligence Division,
Drug Enforcement Administration, U.S.
Department of Justice.
(4) Affected public who will be asked
or required to respond, as well as a brief
abstract:
Primary: Federal, State, Tribal, and
Local, law enforcement agencies.
Other: None.
Abstract: This survey is a critical
component of the National Drug Threat
Assessment and other reports and
assessments produced by the Drug
Enforcement Administration. It provides
direct access to detailed drug threat data
from state and local law enforcement
agencies.
(5) An estimate of the total number of
respondents and the amount of time
estimated for an average respondent to
respond: It is estimated that
approximately 3,500 respondents will
complete a survey response within
approximately 20 minutes.
(6) An estimate of the total public
burden (in hours) associated with the
collection: There are an estimated 1,167
total annual burden hours associated
with this collection.
If additional information is required
contact: Jerri Murray, Department
Clearance Officer, Policy and Planning
Staff, Justice Management Division,
Department of Justice, Two Constitution
Square, 145 N Street NE., Suite 3W–
1407B, Washington, DC 20530.
Dated: June 12, 2013.
Jerri Murray,
Department Clearance Officer for PRA, U.S.
Department of Justice.
[FR Doc. 2013–14347 Filed 6–17–13; 8:45 am]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 12–15]
Belinda R. Mori, N.P.; Decision and
Order
On November 17, 2011, the Deputy
Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration, issued an Order to
Show Cause to Belinda R. Mori, N.P.
(Respondent), of Santa Fe, New Mexico.
The Show Cause Order proposed the
denial of Respondent’s pending
application for a DEA Certificate of
Registration, on the ground that her
‘‘registration would be inconsistent with
the public interest.’’ ALJ Ex. 1, at 1.
The Show Cause Order specifically
alleged that on March 18, 2011,
Respondent applied for a Certificate of
Registration as a mid-level practitioner,
seeking authority to dispense controlled
substances in schedules II through V. Id.
The Order further alleged that
Respondent had previously held a
registration, which authorized her to
dispense controlled substances in
schedules II through V as a mid-level
practitioner but that ‘‘this registration
expired on January 31, 2011.’’ Id.
Next, the Show Cause Order alleged
that ‘‘[b]etween August 29, 2009 and
March 15, 2011, [Respondent] issued
approximately thirty-three purported
prescriptions for alprazolam (a
[s]chedule IV controlled substance) to
[her] daughter without conducting a
medical examination and without
creating a patient record,’’ and that
these prescriptions ‘‘were issued outside
the usual course of professional
practice, in violation of Federal and . . .
state law.’’ Id. (citing 21 CFR 1306.04(a);
N.M Admin. Code tit. 16, §§ 12.2.7(V)
and 12.2.13(N)(5)(g)). The Order further
alleged that ‘‘[o]n or about March 15,
2011, [Respondent] issued a purported
prescription for alprazolam . . . to [her]
daughter . . . while [she was] without
a valid DEA Certificate of Registration,
in violation of Federal and . . . state
law.’’ Id. at 2 (citing 21 U.S.C. 841(a)(1);
N.M. Admin. Code tit. 16,
§ 12.2.13(N)(5)(a)).
On December 5, 2011, Respondent,
through her counsel, requested a
hearing on the allegations. ALJ Ex. 2.
The matter was placed on the docket of
the Office of Administrative Law Judges
(ALJ), and assigned to an ALJ who
proceeded to conduct pre-hearing
procedures.
On December 20, 2011, the
Government filed its pre-hearing
statement. Therein, the Government
provided notice that it intended to elicit
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the testimony of an Agency Diversion
Investigator (DI) that ‘‘on or about April
14, 2011, she spoke with Respondent
about her application for a DEA
Certificate of Registration’’ and ‘‘asked
Respondent whether [she] used her
previous DEA Certificate of Registration
after it expired, and Respondent stated
that she had not.’’ Gov’t Prehr’g
Statement, at 3. The Government also
provided notice that it intended to show
that ‘‘[o]n this same day, [the DI] ran a
prescription monitoring report with the
New Mexico Board of Pharmacy for the
period of February 1, 2011, through
April 14, 2011, and that the report
showed that Respondent issued one
prescription for controlled substances
(alprazolam) after her previous DEA
Certificate of Registration expired,’’ and
that the prescription was for her
daughter and issued ‘‘on or about March
15, 2011.’’ Id. Finally, the Government
provided notice that the DI would
‘‘testify that on or about May 3, 2011,
she interviewed Respondent about the
alprazolam prescription that was issued
after her previous DEA Certificate of
Registration expired,’’ and that
‘‘Respondent informed [the DI] that she
issued the alprazolam prescription to
her daughter because [she] did not have
health insurance and therefore could
not see her treating physician.’’ Id.
On May 1, 2012, the ALJ conducted
a hearing in Albuquerque, New Mexico.
At the hearing, the Government elicited
the testimony of the DI and introduced
various documents into the record;
Respondent testified on her own behalf
and also introduced various documents
into the record. Following the hearing,
both parties submitted briefs containing
their proposed findings of fact,
conclusions of law, and argument.
On July 30, 2012, the ALJ issued her
Recommended Decision (R.D.). Therein,
the ALJ found that the Government had
proved that Respondent violated federal
law because she issued thirty-three
prescriptions to her daughter and ‘‘did
not establish a good faith practitionerpatient relationship with [her] prior to
issuing controlled substance
prescriptions to her.’’ R.D. at 16.
Moreover, the ALJ found that
Respondent ‘‘violated federal law by
issuing a prescription after the
expiration of her DEA Certificate of
Registration.’’ Id. (citing 21 U.S.C.
843(a)(2)). The ALJ thus concluded that
‘‘in light of Respondent’s serious and
undisputed violations of the CSA and
New Mexico law, . . . the Government
has presented a prima facie case that
supports the denial of Respondent’s
application.’’ Id. at 16–17.
The ALJ then addressed whether
Respondent had rebutted the
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Government’s prima facie case. R.D. at
17. The ALJ found that ‘‘Respondent has
both taken responsibility for her actions
and shown remorse for her unlawful
conduct,’’ noting that ‘‘she
demonstrated visible remorse for her
misconduct’’ and ‘‘testified credibly and
candidly about the circumstances
surrounding the misconduct.’’ Id. She
also explained that Respondent’s
testimony regarding her ‘‘health
problems,’’ the ‘‘death of her son in a
motorcycle accident, and her daughter’s
subsequent struggle with mental illness
after losing her health insurance’’ were
‘‘appropriate mitigating factors’’ which
should be considered. Id. at 17–18.
The ALJ further found that although
Respondent had made a false statement
to the DI in an April 2011 phone call
when she denied writing any
prescriptions after her registration had
expired, the ALJ rejected the
Government’s contention that she did so
deliberately. Id. at 18. Instead, the ALJ
found ‘‘that it is quite plausible that
[Respondent] unintentionally made the
false statement,’’ reasoning that ‘‘the
Government’s argument regarding [her]
lack of candor is undercut by the
extensive and voluntary disclosures
[she] made to [the DI] during that April
2011 telephone conversation, namely
that she had not prepared or maintained
any treatment records regarding these
prescriptions.’’ Id. The ALJ thus
reasoned that ‘‘[i]n light of the totality
of [her] interaction with [the DI] and her
credible testimony at the hearing, . . .
her statement, while admittedly false,
does not negatively outweigh her overall
candor with the Agency.’’ Id.
Next, the ALJ found ‘‘that Respondent
has demonstrated specific remedial
measures which she has undertaken to
prevent the reoccurrence of her
unlawful conduct,’’ including her
completion of ‘‘a continuing medical
education class on prescribing for
family members’’ and that she ‘‘has
pledged to cease writing prescriptions
for her daughter or any other family
member.’’ Id. at 19. The ALJ further
noted that Respondent had discussed
her daughter’s treatment with her
psychiatrist and confirmed that all of
her daughter’s prescriptions would
henceforth be issued by him. Id.
The ALJ thus concluded that the
Government’s proposed sanction of
denial would be ‘‘too severe.’’ Id. While
finding that Respondent’s ‘‘misconduct
was . . . serious,’’ the ALJ
recommended that Respondent be
granted a restricted registration,
concluding that she ‘‘has now
demonstrated that she understands the
responsibilities and requirements of a
DEA registrant.’’ Id. at 19–20.
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Having considered the record in its
entirety, I adopt the ALJ’s findings of
fact and conclusions of law except as
discussed below. While I reject the
ALJ’s finding that Respondent violated
the CSA’s prescription requirement
when she prescribed to her daughter as
unsupported by substantial evidence, I
adopt her finding that Respondent
violated DEA regulations when she
prescribed a controlled substance after
the expiration of her registration. I
further reject the ALJ’s finding that
Respondent unintentionally made a
false statement to the DI when she
denied having written any controlled
substance prescriptions after the
expiration of her DEA registration.
Because Respondent has failed to accept
responsibility for her misconduct, I
reject the ALJ’s recommended sanction
and will order that Respondent’s
application be denied.
Findings of Fact
Respondent is a Certified Nurse
Practitioner licensed by the Board of
Nursing for the State of New Mexico.
GX 3, at 3. On June 23, 2010, the
Executive Director of the Board of
Nursing (Board) notified Respondent
that she had reviewed evidence
suggesting that Respondent had
practiced on an expired license (and
thus practiced without a license). GX 4,
at 1. While the Executive Director noted
that ‘‘there is sufficient evidence for the
Board to consider disciplinary actions
against [Respondent’s] nursing license,’’
the Board offered Respondent a
‘‘voluntary reprimand and fine.’’ Id., see
also GX 4, at 3. On July 2, 2010,
Respondent accepted the reprimand, id.
at 2, and in December 2010, the Board
issued her a Voluntary Letter of
Reprimand. GX 5.
Respondent also previously held a
DEA Certificate of Registration, which
authorized her to dispense controlled
substances in schedules II through V, as
a mid-level practitioner, at the
registered address of 3715 Southern
Blvd., Rio Rancho, New Mexico. GX 2,
at 1. On January 31, 2011, the
registration expired. Id. Thereafter, ‘‘no
controlled substances could be
obtained, stored, administered,
prescribed, or dispensed under’’ the
registration. Id. Respondent did not
submit a renewal application until
March 18, 2011. Id.
At some point not clear on the record,
but after Respondent submitted her
renewal application, Respondent called
the DEA Office in Albuquerque
regarding the status of her application.
Tr. 16. The DI who was assigned the
weekly duty of taking phone calls
subsequently returned her call and
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explained that her application had yet
to be assigned to an investigator, but
that it would be and that an investigator
would contact her for further
information. Id.
The DI testified that before she
returned Respondent’s phone call, she
had determined that Respondent had
previously held a DEA registration.1 Id.
at 17. The DI also testified that before
she returned Respondent’s call, she had
queried the Board of Nursing’s Web site
and noted that Respondent had been
reprimanded by the Board. Id.
During the phone call, the DI verified
with Respondent that she had
previously held a registration. Id. The DI
also told Respondent that as part of the
pre-registration investigation, she would
be contacting the Board for more
information regarding the basis of the
reprimand. Id. She then discussed with
Respondent the reason for having to
submit a new application. Respondent
told the DI that her registration had
expired because she had failed to renew
it. Id. at 22.
The DI asked Respondent if she had
written any prescriptions past the
expiration date; Respondent ‘‘stated she
had not.’’ Id. The DI then told
Respondent that she ‘‘would be running
a prescription monitoring program
report [PMP]’’ and ‘‘explained to [her]
what the PMP was and what it would
show me.’’ Id. The DI told Respondent
that the PMP ‘‘would show the
prescriptions that were filled pursuant
to her DEA number for a certain time
period,’’ id, and ‘‘explained that [she]
would be querying that to verify the
information she had provided of not
writing any prescriptions with an
expired DEA number.’’ Id. at 23.
Subsequently, the DI ran the PMP
from August 1, 2009 through August 5,
2011. Id. at 23; GX 6. The DI testified
that ‘‘the document shows . . . that Ms.
Mori had self-prescribed a controlled
substance in August of 2009, and also
that there was a patient by the name of
Mia Mori who had a prescription
written and filled on March 15 of 2011.’’
Id.; GX 6, at 1. The DI testified that the
report listed additional prescriptions
written by Respondent for Mia Mori,
which were for two schedule IV
controlled substances, alprazolam and
zolpidem, and which were written
between August 29, 2009 through March
1 According to the DI, at the time of her first
phone call with Respondent, the matter had yet to
be assigned to an Investigator. However, the matter
was eventually assigned to the DI. The record is less
than transparent regarding whether at the time of
the DI’s initial phone call with Respondent she had
queried the State Board’s Web site as well as
determined that Respondent had previously been
registered or whether she made these inquiries prior
to a second phone conversation.
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15, 2011. Id. at 24–25; GX 6, at 1–3. The
PMP report also shows that on August
12, 2009, Respondent self-prescribed
thirty tablets of zaleplon 10 mg, a
schedule IV controlled substance. GX 6,
at 1; 21 CFR 1308.14(c)(51).
The DI then testified that
Respondent’s DEA registration had
expired on January 31, 2011. Id. at 25.
She also reiterated that Respondent had
not told her about the March
prescription when she spoke to her in
April 2011. Id.
Next, the DI testified regarding the
process for renewing a registration and
the procedures used by the Agency to
notify a registrant regarding an
impending expiration. More
specifically, the DI explained that a DEA
registration does not renew
automatically, and that a ‘‘renewal
application . . . has to be submitted by
the registrant, asking for a renewal of
the number.’’ Id. The DI further
explained that the expiration date is
printed on the face of the registration
certificate, and that ‘‘the [Agency’s]
registration unit . . . automatically
generates two notices before the
expiration, advising [the registrant that]
you’re coming close to the expiration
date.’’ Id. at 25–26. According to the DI,
if a registration ‘‘actually does expire
before it is renewed . . . a delinquency
notice is mailed out to the registered
address of the registrant.’’ Id. at 26.
The DI testified that after she
discovered the March 15, 2011
prescription, she spoke again with
Respondent by telephone. The DI
explained to Respondent that she had
run the PMP report and that there were
three prescriptions filled after the
expiration date which were written
prior to the expiration date, and one
prescription that was written after the
expiration date that was also filled. Id.
at 26. Regarding these prescriptions, the
DI testified that Respondent told her
‘‘that Mia Mori was her daughter and
that she had written the prescription
after her daughter had lost her health
insurance, and that she had forgotten to
advise me of that.’’ Id. at 26–27.
Respondent told the DI ‘‘that her
daughter had seen a psychiatrist’’ and
that she was ‘‘treating her daughter’s
anxiety and that was why she had
prescribed the alprazolam to her.’’ Id. at
27.
The DI then asked Respondent to
meet her and bring her daughter’s
patient chart for review. Id. Respondent
told the DI that she had not created a
patient chart for her daughter, and that
she did not maintain any records
regarding periodic evaluations of her
daughter to determine whether her
treatment was proceeding as it should.
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Id. at 27–28. Moreover, when asked by
the Government’s counsel if she knew if
Respondent ‘‘was conducting a medical
examination of any sort,’’ the DI
answered that she did ‘‘not know.’’ Id.
at 28.
The DI ran another PMP report using
Mia Mori’s name; the report covered the
period from January 2006 through
December 8, 2011. GX 7. The report
shows that Respondent first began
prescribing to her daughter in April
2007; the first prescription was for
hydrocodone with acetaminophen, a
schedule III controlled substance. Tr.
29; GX 7, at 2.
The report also shows that
Respondent wrote multiple
prescriptions for her daughter for both
zolpidem and alprazolam. These
include prescriptions for 90 tablets of
zolpidem 10 mg on July 28 and October
17, 2007, as well a prescription for 30
tablets of zolpidem 10 mg on August 29,
2009, which was refilled on September
26, 2009. GX 7, at 2.
As for the alprazolam prescriptions,
on October 23, 2009, Respondent wrote
a prescription for 30 tablets of
alprazolam 0.5 mg; this prescription was
refilled on November 8, 18, and 29. Id.
On December 9, 2009, Respondent
wrote a prescription for her daughter for
60 tablets of alprazolam 0.5 mg; this
prescription was refilled on December
28 and January 14, 2010. Id. This was
followed by a February 3, 2010
prescription for 30 tablets of alprazolam
0.5 mg, which was refilled on February
12, 22, and March 3, 2010; as well as
another prescription for 30 tablets of
alprazolam 0.5 mg on March 14, 2010
(which was not filled until March 25,
2010). Id.
On April 15, 2010, Respondent wrote
another prescription for 60 tablets of
alprazolam 0.5 mg, which was refilled
on May 20, June 15, and July 2, 2010.
Id. This was followed by prescriptions
for 30 tablets of alprazolam 0.5 mg on
July 28, 2010 (which was refilled on
August 9, 19, and 29), on September 8,
2010 (which was refilled on September
20, October 4, 15 and 27), and on
January 14, 2011 (which was refilled
four times through March 6, 2011).
Respondent wrote a final prescription
for 30 alprazolam 0.5 mg for her
daughter on March 15, 2011, which was
43 days after her DEA registration had
expired. Id.
The DI testified that the 2007
prescriptions were noteworthy because
Respondent’s daughter turned twentytwo in 2009, and the DI’s understanding
was that she had lost her health
insurance upon reaching this age. Tr.
29. The DI stated that ‘‘based on the
information that [Respondent] provided,
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her daughter would have had health
insurance’’ in 2007. Id. at 29–30.
The DI continued her investigation by
contacting the pharmacies listed as
having filled the controlled substances
and asking them to pull the original
prescriptions, the signature log, and the
method of payment for those
prescriptions. Id. at 31. Those
documents indicated that each of those
prescriptions was called in by
Respondent for her daughter, and that
Mia Mori had picked up the
prescriptions. Id.
The DI testified that Respondent
issued her daughter a total of thirtythree controlled substance
prescriptions. Id. Of these, eleven were
original prescriptions; the other twentytwo were refills. Id.
The DI testified that she provided a
copy of her report to the New Mexico
Board of Nursing, and that after the
report was forwarded to the Board, it
initiated a complaint and subsequently
took action against Respondent’s
nursing license. Id. at 32. This resulted
in a Settlement Agreement between the
Board and Respondent in December
2011. Id. at 33–34; RX 4, at 2. Under the
Settlement Agreement, Respondent
received a letter of reprimand and was
required to complete a continuing
education course in patient/physician/
family caregiver relationships. RX 4, at
2. Respondent completed the course in
December 2011. Id. at 5.
Respondent testified that in 2004,
after being released from active duty in
the army, she had suffered a heart
attack, and that about a year and a half
later, her son was killed in a motorcycle
accident. Tr. 53. Shortly thereafter, her
daughter complained that ‘‘she was
going crazy’’ and ‘‘needed to see a
psychiatrist.’’ Id. at 53–54. Respondent
stated that she took her daughter to a
psychiatrist, who diagnosed her with
‘‘severe anxiety disorder with an OCD
component.’’ Id. at 54. Subsequently,
the psychiatrist recommended that
Respondent’s daughter see a specialist
in OCD, and so she began treating with
a Dr. Summers. Id.
When asked by her counsel as to why
she had written her daughter
prescriptions for Abilify (a noncontrolled prescription drug) and
alprazolam, Respondent testified that
her daughter’s OCD causes thoughts of
self-harm, and she wanted to ensure that
her daughter was mentally stable. Id.
Respondent testified that she ‘‘could not
lose another child.’’ Id.
Respondent then testified regarding
several other prescriptions she had
issued for her daughter. Specifically,
Respondent testified that she prescribed
Ambien (zolpidem) for her daughter on
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two occasions, including on August 29,
2009 (as well as on another date which
she did not recall) because ‘‘she was
unable to sleep at all.’’ Id. at 55. See also
GX 7, at 2 (zolpidem prescriptions
issued on 7/28/07 and 10/16/07).
Respondent testified that Ambien had
been prescribed for her daughter by her
treating physicians, but did not state
when or by whom specifically.2 Id. at
56. Respondent testified that she also
wrote her daughter a prescription for
Percodan on April 21, 2007, when she
had inflamed tonsils. Id. at 58.
Respondent stated that one of the
reasons she wrote the prescriptions for
her daughter was because she ‘‘did not
have insurance and the cost of the
drugs,’’ and ‘‘to maintain her sanity, so
that she would not commit suicide.’’ Id.
However, when the Government asked
Respondent if her daughter had been
diagnosed as suicidal, she stated: ‘‘I
have not read her records.’’ Id. at 61.
Moreover, Respondent’s evidence shows
that her daughter resumed treatment
with her psychiatrist on January 13,
2011. RX 3, at 11. Yet the next day,
Respondent issued to her daughter
another prescription for thirty
alprazolam with four refills. GX 8, at 40.
Moreover, on March 15, 2011,
Respondent issued another prescription
for thirty alprazolam, which also
authorized multiple refills. GX 8, at 45.
Respondent offered no explanation as to
why she issued these prescriptions
when her daughter had resumed seeing
her psychiatrist.
Respondent was also asked whether
she looked into care alternatives when
she knew her daughter would not be
able to continue seeing her doctor. Id. at
62. Respondent first stated she did not,
but then changed her response to ‘‘yes.’’
Id. Respondent then testified that there
were neither free therapy services nor
group therapy sessions available for her
daughter, and that because she was
stable, she decided to just continue her
on the medication. Id. Respondent then
admitted that when she informed the
doctor that her daughter no longer had
health insurance, he did not
immediately cease all ties with her. Id.
at 63. When asked whether she had
developed a treatment plan with her
daughter’s psychiatrist for the period
when her daughter did not have health
insurance, Respondent replied that the
psychiatrist had already created a
treatment plan. Id.
Regarding the prescriptions she
issued her daughter, Respondent also
2 Other evidence corroborates Respondent’s
testimony that Ambien had been prescribed to her
daughter on multiple occasions by a Dr. D.R.,
beginning in May 2006. GX 7, at 2.
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introduced several exhibits. The first of
these is an affidavit by her daughter’s
psychiatrist, who stated that he had
treated her daughter from April 2006
through 2011, and that he had
diagnosed her with ‘‘an anxiety disorder
and secondary depression due to
obsessive compulsive neurosis.’’ RX 1.
The psychiatrist stated that he had
prescribed Abilify and alprazolam to
Respondent’s daughter. Id. The
psychiatrist further stated that it was his
understanding that ‘‘due to insurance
concerns,’’ Respondent had ‘‘actually
filled out prescriptions for her daughter
from the time frame of August 2010
through March 2011 3,’’ and that ‘‘[s]uch
prescriptions would have been in
conformance with my desired treatment
including drugs ordered, strength
indicated, and number of pills to be
given.’’ Id. Finally, the psychiatrist
expressed his belief that the
‘‘prescriptions were written in
conformance with my treatment and do
not indicate any prescription regime
that was not recommended by me.’’ Id.
Yet, the psychiatrist did not address
why Respondent had continued to
prescribe alprazolam after her daughter
had resumed treatment with him.
Regarding the prescribing class the
Board required her to take, Respondent
testified that ‘‘it’s common practice that
is not well established to not prescribe
for your family members, and that this
is a real issue.’’ Id. at 59. She further
testified that she understood that she
can never again prescribe to a family
member. Id. And when asked by the ALJ
if she had issued any prescriptions to
her daughter since taking the class on
prescribing to family members,
Respondent answered ‘‘absolutely not.’’
Id. at 66.
Respondent also acknowledged that
in December 2010, the State Board
issued her a reprimand for not renewing
her state license in a timely manner. Id.
at 64–65. When the Government asked
if it was correct that she then let her
DEA registration lapse in January 2011,
Respondent replied:
Well, I didn’t let it. I just was unaware of
the expiration, and I didn’t know this until
I started refilling my New Mexico pharmacy
license, where they require you to put in the
expiration of your DEA. At that point, I
3 In a letter written by the psychiatrist to
Respondent’s counsel approximately one week
before he executed his affidavit, the psychiatrist
stated that ‘‘[a]pparently, in 2009[,] she
[Respondent’s daughter] was unable to afford health
insurance. She was lost to follow-up until January
2011.’’ RX 2, at 1. In resolving the apparent conflict
between the dates during which Respondent’s
daughter lacked insurance, I give no weight to the
psychiatrist’s letter (which is unsworn) and rely
solely on the affidavit.
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called the DEA in El Paso, to ask them when
that was, and that’s how I found out. . . .
Id. at 64. Respondent admitted that
notwithstanding having been
reprimanded for not renewing her state
license in a timely manner, she did not
then check her DEA registration to
determine if it was going to expire soon.
Id. at 65. Indeed, she described herself
as being ‘‘very much’’ scattered during
the previous five years with regard to
filing the renewals for her various
licenses on time. Id. at 53. However, in
response to a series of questions
regarding whether she now understood
the importance of keeping her licenses
current, Respondent testified that she
‘‘understood the gravity’’ of the
situation, id., and on cross-examination,
she testified that she had recently
renewed her pharmacy license and had
‘‘sent it in early.’’ Id. at 66.
Discussion
Section 303(f) of the Controlled
Substances Act (CSA) provides that the
Attorney General ‘‘may deny an
application for [a practitioner’s]
registration if he determines that the
issuance of such a registration is
inconsistent with the public interest.’’
21 U.S.C. 823(f). In making the public
interest determination, the CSA directs
that the following factors be considered:
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(1) The recommendation of the appropriate
State licensing board or professional
disciplinary authority.
(2) The applicant’s experience in
dispensing . . . controlled substances.
(3) The applicant’s conviction record under
Federal or State laws relating to the
manufacture, distribution, or dispensing of
controlled substances.
(4) Compliance with applicable State,
Federal, or local laws relating to controlled
substances.
(5) Such other conduct which may threaten
the public health and safety.
Id.
‘‘[T]hese factors are . . . considered
in the disjunctive.’’ Robert A. Leslie,
M.D., 68 FR 15227, 15230 (2003). It is
well settled that I ‘‘may rely on any one
or a combination of factors, and may
give each factor the weight [I] deem[]
appropriate in determining whether a
registration should be revoked.’’ Id.; see
also MacKay v. DEA, 664 F.3d 808, 816
(10th Cir. 2011); Volkman v. DEA, 567
F.3d 215, 222 (6th Cir. 2009); Hoxie v.
DEA, 419 F.3d 477, 482 (6th Cir. 2005).
Moreover, while I am required to
consider each of the factors, I ‘‘need not
make explicit findings as to each one.’’
MacKay, 664 F.3d at 816 (quoting
Volkman, 567 F.3d at 222); see also
Hoxie, 419 F.3d at 482.4
4 In short, this is not a contest in which score is
kept; the Agency is not required to mechanically
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The Government has ‘‘the burden of
proving that the requirements for . . .
registration . . . are not satisfied.’’ 21
CFR 1301.44(d). However, where the
Government has met its prima facie
burden of showing that issuing a new
registration to the applicant would be
inconsistent with the public interest, an
applicant must then ‘‘present sufficient
mitigating evidence’’ to show why she
can be entrusted with a new
registration. Medicine ShoppeJonesborough, 73 FR 364, 387 (2008)
(quoting Samuel S. Jackson, 72 FR
23848, 23853 (2007) (quoting Leo R.
Miller, 53 FR 21931, 21932 (1988))).
In this matter, while I reject the ALJ’s
conclusion that Respondent violated 21
U.S.C. 843(a)(2), I find Respondent
violated DEA regulations when she
issued a controlled substance
prescription when she was not
registered to do so. Accordingly, I agree
with the ALJ’s conclusion that factors
two (Respondent’s experience in
dispensing controlled substances) and
four (Respondent’s compliance with
applicable laws related to controlled
substances) support the denial of
Respondent’s application. R.D. at 16–17.
However, with respect to factor five, I
reject the ALJ’s conclusion that
Respondent did not intentionally make
a false statement to the DI when she
denied having written any controlled
substance prescriptions after her
registration expired. Moreover, I reject
the ALJ’s conclusion that Respondent
has ‘‘both taken responsibility for her
actions and shown remorse for her
misconduct.’’ Id. at 17. Indeed,
Respondent offered no remorse for her
misconduct in prescribing to her
daughter after her registration expired.
Nor did she offer any testimony
addressing the materially false
statement she made to the DI when she
denied writing controlled substance
prescriptions after the expiration of her
registration.5
count up the factors and determine how many favor
the Government and how many favor the registrant.
Rather, it is an inquiry which focuses on protecting
the public interest; what matters is the seriousness
of the registrant’s misconduct. Jayam Krishna-Iyer,
74 FR 459, 462 (2009). Accordingly, as the Tenth
Circuit has recognized, findings under a single
factor can support the revocation of a registration.
MacKay, 664 F.3d at 821. Likewise, findings under
a single factor can support the denial of an
application.
5 As for factor one, I acknowledge that
Respondent holds the requisite New Mexico
certified nurse practitioner and controlled
substance licenses. However, there is no
‘‘recommendation’’ one way or the other from the
various state authorities as to whether Respondent’s
application should be granted.
While the possession of state authority to
dispense controlled substances is a prerequisite for
obtaining and maintaining a DEA registration, the
CSA vests this Agency with ‘‘a separate oversight
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Factors Two and Four—Respondent’s
Experience in Dispensing Controlled
Substances and Compliance With
Applicable Laws Related to Controlled
Substances
Under a longstanding Agency
regulation, ‘‘[a] prescription for a
controlled substance [is not] effective
[unless it is] issued for a legitimate
medical purpose by an individual
practitioner acting in the usual course of
[her] professional practice.’’ 21 CFR
1306.04(a). This regulation further
provides that ‘‘an order purporting to be
a prescription issued not in the usual
course of professional treatment . . . is
not a prescription within the meaning
and intent of [21 U.S.C. § 829] and . . .
the person issuing it, shall be subject to
the penalties provided for violations of
the provisions of law relating to
controlled substances.’’ Id.; see also 21
U.S.C. 802(10) (defining the term
‘‘dispense’’ as meaning ‘‘to deliver a
controlled substance to an ultimate user
by, or pursuant to the lawful order of,
a practitioner, including the prescribing
and administering of a controlled
substance’’) (emphasis added).
As the Supreme Court recently
explained, ‘‘the prescription
requirement . . . ensures patients use
controlled substances under the
supervision of a doctor so as to prevent
addiction and recreational abuse. As a
corollary, [it] also bars doctors from
peddling to patients who crave the
drugs for those prohibited uses.’’
Gonzales v. Oregon, 546 U.S. 243, 274
(2006) (citing United States v. Moore,
423 U.S. 122, 135, 143 (1975)).
Under the Controlled Substances Act,
‘‘it is fundamental that a practitioner
must establish a bona fide doctorpatient relationship in order to act ‘in
responsibility [apart from that which exists in state
authorities] with respect to the handling of
controlled substances.’’ Mortimer B. Levin, 55 FR
8209, 8210 (1990). DEA has therefore long
recognized that it has ‘‘a statutory obligation to
make its independent determination as to whether
the granting of [a registration] would be in the
public interest.’’ Id. Thus, while Respondent
satisfies this prerequisite for obtaining registration,
this factor is not dispositive of the public interest
inquiry. Id. (holding that practitioner’s
reinstatement by state board ‘‘is not dispositive’’ in
public interest inquiry).
As for factor three, while a history of criminal
convictions for offenses involving the distribution
or dispensing of controlled substances is a highly
relevant consideration in the public interest
inquiry, there are any number of reasons why a
registrant may not have been convicted of such an
offense, and thus, the absence of such a conviction
is of considerably less consequence. Jayam KrishnaIyer, 74 FR 459, 461 (2009). Accordingly, that
Respondent has not been convicted of an offense
related to the distribution or dispensing of a
controlled substance is also not dispositive of
whether granting her application ‘‘is consistent
with the public interest.’’ 21 U.S.C. 823(f); KrishnaIyer, 74 FR at 461.
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the usual course of professional
practice’ and to issue a prescription for
a legitimate medical purpose.’’ Patrick
W. Stodola, 74 FR 20727, 20731 (2009)
(citing Moore, 423 U.S. at 141–43). The
CSA generally looks to state law and
medical practice standards to determine
whether a practitioner has established a
valid practitioner-patient relationship.
See United Prescription Services, Inc.,
72 FR 50397, 50407 (2007) (citation
omitted); but see 21 U.S.C. 829(e).
Under New Mexico regulations, a
Certified Nurse Practitioner (CNP) who
has ‘‘fulfilled the requirements for
prescriptive authority may prescribe
and distribute dangerous drugs
including controlled substances . . .
within [her] clinical specialty and
practice setting.’’ N.M. Code
§ 16.12.2.13N(5). These regulations
further provide that a CNP ‘‘may
prescribe, provide samples of and
dispense any dangerous drug to a
patient where there is a valid
practitioner-patient relationship as
defined in’’ N.M. Code § 16.12.2.7. The
latter provision defines a ‘‘valid
practitioner-patient relationship’’ as:
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a professional relationship between the
practitioner and the patient for the purpose
of maintaining the patient’s well-being. At
minimum, this relationship is an interactive
encounter between the practitioner and
patient involving an appropriate history and
physical or mental examination, ordering
labs or diagnostic tests sufficient to make a
diagnosis and providing, prescribing or
recommending treatment, or referring to
other health care providers. A patient record
must be generated by the encounter.
Id. § 16.12.2.7.V.
Based on this regulation, the
Government argues that Respondent
violated both federal and state law when
she prescribed controlled substances
such as alprazolam and Ambien
(zolpidem) to her daughter because she
‘‘kept no prescription records, kept no
patient charts, and performed no
physical or mental examinations.’’ Gov’t
Br. 8. It further argues that ‘‘[a]
practitioner is not excused from
establishing a valid [practitioner]patient relationship simply because
another practitioner has previously
established a valid relationship and the
course of prescribed controlled
substances is the same as with the prior
practitioner.’’ Id. at 7 (citing Randall L.
Wolff, 77 FR 5106 (2012)). With respect
to the latter contention, the Government
argues that the psychiatrist’s ‘‘postapproval of the program, [in] an attempt
to bring validity to the prescriptions[,]
instead reveals two New Mexico
practitioners ignoring or unaware of the
simple fact that a doctor-patient
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relationship is not transferrable.’’ Id. at
8 (citations omitted).
As support for its contention that
Respondent ‘‘performed no physical or
mental examinations,’’ the Government
cites the DI’s testimony. Gov’t Br. 4
(citing Tr. 27–28). However, while the
DI testified that Respondent indicated
‘‘that she had never made a patient chart
for her daughter’’ or provided her ‘‘with
any prescription records,’’ id. (citing Tr.
27), on the issue of whether Respondent
had examined her daughter, the DI’s
testimony lacked probative force.
More specifically, when asked if
Respondent told her ‘‘about weekly,
monthly sessions of meeting with her
daughter to diagnose or to make sure the
treatment was proceeding as it should,’’
the DI testified: ‘‘No, she did not.’’ Tr.
27. When the Government followed up
by asking the DI if she knew ‘‘why
[Respondent] didn’t provide you with
any of that information?’’ the DI
testified: ‘‘Because she stated she had
not maintained any of those
documents.’’ Id. And when asked ‘‘do
you know if she [Respondent] was
conducting a medical examination of
any sort?,’’ the DI testified: ‘‘No, I do not
know.’’ Id. at 28.
Significantly, at no point did the
Government ask the DI if she had
specifically asked Respondent whether
she had examined her daughter or had
performed periodic evaluations of her
and been told that she had not. Nor,
during Respondent’s testimony, did the
Government ask her if she had
examined her daughter or performed
periodic evaluations of her.6
To be sure, there are cases in which
evidence that a practitioner failed to
create medical records has given rise to
the inference that the practitioner failed
to perform those tasks (such as taking
the necessary history and performing an
appropriate examination) which are
essential for properly diagnosing and
periodically re-evaluating her patient.
Yet this case stands on a substantially
different footing than those cases,
because even if it is not within
professional ethics for a Nurse
Practitioner to prescribe to a family
member,7 the evidence is undisputed
6 There is evidence that Respondent practiced at
a med spa. See GX 1 (Respondent’s application); Tr.
52 (Respondent’s testimony that in 2006, she had
‘‘moved into the medical aesthetics industry’’).
However, while New Mexico’s regulations limit a
CNP’s prescribing authority to ‘‘their clinical
specialty and practice setting,’’ N.M. Code
§ 16.12.2.13N(5), and it seems most unlikely that
prescribing for psychiatric conditions was within
Respondent’s clinical specialty, the Government
made no such contention.
7 It is noted that the State Board required
Respondent to take a course in ‘‘patient/physician/
family caregiver relationships.’’ RX 4, at 2. While
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36587
that Respondent was intimately
involved in her daughter’s wellbeing
and the decision to seek psychiatric
care. Thus, while Respondent may not
have documented a history of her
daughter’s psychiatric condition, she
was obviously well aware of her
daughter’s condition. So too, she was
well aware of her daughter’s diagnosis
and her response to treatment. And
significantly, upon resuming active
treatment of Respondent’s daughter, her
psychiatrist made the same assessment
of her condition and continued to
prescribe alprazolam to her. See RX 3,
at 9–10.
As noted above, the Government also
cites the Agency decision in Wolff, to
argue that a ‘‘doctor-patient relationship
is not transferrable’’ and that
Respondent ‘‘ignor[ed] clear laws that
make such transference of the doctorpatient relationship a violation.’’ Gov’t
Br. 8. The Government ignores that the
decision in Wolff specifically cited the
testimony of an expert witness that it
was not ‘‘within the standard of care’’ in
the State where Dr. Wolff practiced ‘‘for
a physician to ‘perpetuate[] the issuance
of controlled substances ordered by
another doctor without first establishing
his own valid doctor-patient
relationship.’ ’’ 77 FR at 5107 n.2.
Contrary to the Government’s
it seems unlikely that the Board would have
required Respondent to take this course if
prescribing to a family member was not a violation
of professional standards, the Board’s Order
contains no reference to any such standard. See
generally RX 4. Nor does the Government cite to
any New Mexico statute, board regulation, policy
statement, or decision (of either the Board or state
courts) holding that prescribing to family members
exceeds the bounds of professional practice. It also
did not sponsor any expert testimony on the issue.
In her decision, the ALJ sidestepped the issue of
the adequacy of the Government’s proof, reasoning
that ‘‘[t]he parties acknowledge that [Respondent]
violated both federal and state law when she issued
the thirty-three prescriptions to’’ her daughter. R.D.
at 16 (citing, inter alia, Tr. 45). However, the cited
portion of the transcript was simply the opening
statement of Respondent’s counsel and not
testimony. Therein, Respondent’s counsel stated:
‘‘Should she have written prescriptions for her
daughter? The answer is, no, she shouldn’t have.’’
Tr. 45.
Moreover, even were I to treat this statement as
evidence, there are many things that people do that
they shouldn’t do. But that does not necessarily
make the particular act a violation of a law or
regulation. Given that the State Board required
Respondent to take a course in prescribing to family
members, Respondent may well have recognized
that doing so was unethical or constituted
malpractice. While Respondent testified that
prescribing to family members ‘‘is a real issue,’’ Tr.
59, on cross-examination, the Government did not
ask Respondent why she now recognized that doing
so ‘‘is a real issue’’ or why she should not have
written the prescriptions, and in any event, her
acknowledgement does not constitute an admission
that her ‘‘actions completely betrayed any
semblance of legitimate medical treatment’’ and
thus constituted drug dealing. United States v.
Feingold, 454 F.3d 1001, 1010 (9th Cir. 2006).
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understanding, neither the CSA, nor
Agency regulations, address the issue of
whether, and under what
circumstances, a prescriber-patient
relationship is transferable. Rather, this
is an issue which can be decided only
by reference to the standards adopted by
the New Mexico authorities and the
accepted standards of professional
practice. Here, however, the
Government cites to no state authority
(whether a statute, regulation,
administrative or judicial decision, or
policy statement) to support its
contention that Respondent violated
‘‘clear laws.’’ Nor did it offer any expert
testimony to this effect.
Thus, while Respondent’s failure to
create a patient record for her daughter
provides some evidence that
Respondent lacked a legitimate medical
purpose in prescribing alprazolam to
her daughter, I conclude that the record
as a whole does not support a finding
that she violated the CSA’s prescription
requirement.8 As for whether her failure
to create a patient record is, by itself,
sufficient to establish that she
prescribed without a valid practitionerpatient relationship under New Mexico
law, I conclude that that was a matter
for state authorities. In short, I conclude
that the Government’s evidence
establishes only that Respondent did
not create state-required medical
records. See N.M. Code §§ 16.12.2.7.V,
16.12.2.13.N(5)(g).
The Government’s evidence does,
however, establish that Respondent’s
registration expired on January 31, 2011,
GX 2, and that on March 15, 2011,
Respondent issued her daughter another
prescription for alprazolam. See GX 7, at
1; GX 8, at 45. Under federal law, it is
‘‘unlawful for any person knowingly or
intentionally . . . to use in the course
of the . . . dispensing of a controlled
substance, . . . a registration number
which is . . . expired.’’ 21 U.S.C.
843(a)(2).
Regarding this violation, the DI
testified that the expiration date of a
registration ‘‘is printed on the
certificate’’ and that the Agency’s
registration unit ‘‘automatically
generates two notices before the
expiration’’ advising a registrant of the
impending expiration. Tr. 25–26. The DI
also testified that after the expiration of
a registration, a delinquency notice is
also mailed to the registrant. Id. at 26.
Respondent’s registration was not
‘‘retired from the DEA computer system
[until] March 1, 2011.’’ GX 2, at 1.
However, the Government offered no
8 It is also noted that the Government makes no
claim that the drugs Respondent prescribed to her
daughter were being abused or diverted to others.
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evidence that these notices were
actually mailed to Respondent, let alone
evidence as to what address they were
sent.9
At the hearing, Respondent asserted
that she ‘‘was just unaware of the
expiration’’ of her registration, and
‘‘didn’t know this until [she] started
refilling [sic] [her] New Mexico
pharmacy license, where they require
you to put in the expiration of your
DEA.’’ Tr. 64. She further asserted that
notwithstanding the reprimand she had
received in late December 2010 for
practicing nursing without a license, she
did not check her DEA registration to
see if it was due to expire soon. Id. at
65. The Government did not, however,
ask Respondent when she had filled out
her pharmacy license application, or
introduce any documentary evidence
establishing the date on which she did
this.
Notwithstanding Respondent’s
testimony (which the ALJ found to be
credible) that she was unaware of the
expiration of her registration, the ALJ
found that Respondent ‘‘violated federal
law by issuing a prescription after the
expiration of her’’ registration. R.D. at
16 (citing 21 U.S.C. 843(a)(2)). However,
as explained above, establishing a
violation of section 843(a)(2) requires
proof that Respondent knowingly issued
the prescription after the expiration of
her registration. As the D.C. Circuit has
explained, to establish knowledge, the
Government must either prove that
when she wrote the March 15, 2011
prescription, Respondent had actual
knowledge that her registration had
expired or that she was willfully blind
or deliberately indifferent to that fact
that her registration had expired. Cf.
United States v. Alston-Graves, 435 F.3d
331 (D.C. Cir. 2006). However, if
Respondent ‘‘act[ed] through ignorance,
mistake or accident,’’ id. at 337, she did
not act with the requisite knowledge.
Here, the ALJ found Respondent’s
testimony credible that she was
unaware of the expiration of her
registration at the time she issued the
9 According to the Government’s evidence,
Respondent was registered at the address of PMG
GI, 3715 Southern Blvd., Rio Rancho, New Mexico.
GX 2, at 1. However, on her application,
Respondent listed her proposed registered address
as Eden Medspa, 405 Kiva Court, Santa Fe, New
Mexico. GX 1, at 1. Under federal law, ‘‘[e]very
registrant . . . shall be required to report any
change of professional or business address in such
manner as the Attorney General shall by regulation
require.’’ 21 U.S.C. 827(g); see also 21 CFR 1301.51
(providing procedure for modifying address). While
Respondent was required to inform the Agency that
she had changed her address and modify her
registration, no such allegation was raised by the
Government. Moreover, no evidence was adduced
as to whether her mail had been forwarded to her
by the clinic listed on her expired registration.
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prescription and did not become aware
of its expiration until she filed her
application for her state pharmacy
license and was required to provide the
expiration date. Notably, the
Government adduced no evidence
sufficient to support the rejection of the
ALJ’s credibility finding. As explained
above, the Government produced no
evidence establishing the date on which
she filed her pharmacy license
application. Nor did it establish when
Respondent had last looked at her DEA
registration. And while there is
evidence that various notices regarding
the expiration of her registration were
likely sent to Respondent, there is no
evidence that the notices were mailed to
her new address, or forwarded from her
registered address to either her new
registered address or her mailing
address. See GX 1. Thus, the
Government has failed to prove that
Respondent either had actual
knowledge of, or was willfully blind to,
the fact that her registration had
expired. Rather, the evidence supports
the conclusion that Respondent was
simply ignorant of the fact that her
registration had expired. Accordingly,
the ALJ’s conclusion that Respondent
violated 21 U.S.C. 843(a)(2) is not
supported by substantial evidence.
However, the Controlled Substances
Act requires that ‘‘[e]very person who
dispenses . . . any controlled
substance, shall obtain from the
Attorney General a registration issued in
accordance with the rules and
regulations promulgated by him.’’ 21
U.S.C. 822(a)(2). Agency regulations
further provide that ‘‘[a] prescription for
a controlled substance may be issued
only by an individual practitioner who
is . . . [e]ither registered or exempted
from registration. . . .’’ 10 21 CFR
1306.03(a). Cf. id. § 1301.13(a) (‘‘No
person required to be registered shall
engage in any activity for which
registration is required until the
application for registration is
granted. . . .’’). To establish a violation
of 21 CFR 1306.03(a), the Government is
required to prove only that Respondent
issued a prescription for a controlled
substance when she was not registered
to do so; it is not required to prove that
Respondent knew that she lacked a
valid registration when she issued the
prescription. Accordingly, I find that
Respondent violated DEA regulations
when she issued the March 15, 2011
alprazolam prescription.11
10 Respondent makes no claim that she was
exempt from registration.
11 While there was also evidence that Respondent
self-prescribed thirty tablets of zaleplon, see GX 6,
at 1, the Government offered no further evidence or
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Factor Five—Such Other Conduct
Which May Threaten Public Health and
Safety
In making the public interest
determination, ‘‘this Agency also places
great weight on a registrant’s candor,
both during an investigation and in any
subsequent proceeding.’’ Robert H.
Hunt, 75 FR 49995, 50004 (2010); see
also, e.g., The Lawsons, Inc., t/a The
Medicine Shoppe Pharmacy, 72 FR
74334, 74338 (2007); Rose Mary Jacinta
Lewis, 72 FR 4035, 4042 (2007) (holding
that lying under oath in proceeding to
downplay responsibility supports
conclusion that physician ‘‘cannot be
entrusted with a registration’’). As the
Sixth Circuit has recognized, ‘‘[c]andor
during DEA investigations properly is
considered by the DEA to be an
important factor when assessing
whether a . . . registration is consistent
with the public interest.’’ Hoxie, 419
F.3d at 483.
The Government argues that
Respondent knowingly made a false
statement to the DI when the DI asked
her if she had written any prescriptions
after the expiration of her registration
and Respondent denied doing so. Gov’t
Br. 11. The ALJ rejected the
Government’s contention, explaining
that she found it ‘‘quite plausible that
[Respondent] unintentionally made the
false statement to’’ the DI. R.D. at 18. As
support for her conclusion, the ALJ
reasoned that ‘‘the Government’s
argument regarding [Respondent’s] lack
of candor is undercut by the extensive
and voluntary disclosures which
[Respondent] made to [the DI] during
that April 2011 telephone conversation,
namely that she had not prepared or
maintained any treatment records
regarding these prescriptions.’’ Id.
(emphasis added). The ALJ thus
concluded that ‘‘[i]n light of the totality
of [Respondent’s] interaction with [the
DI] and her credible testimony at the
hearing, . . . her statement, while
admittedly false, does not negatively
outweigh her overall candor with the
Agency.’’ Id.
I reject the ALJ’s finding that
Respondent unintentionally made the
false statement. Indeed, the ALJ’s
conclusion clearly rests on a misreading
of the record, which while not a model
of clarity, nonetheless establishes that
Respondent made the false statement in
a phone call which occurred before the
DI had run the PMP, and in fact, during
this phone call, the DI specifically
discussed with Respondent that her
registration had expired and told her
that she would be running a PMP report
argument regarding the lawfulness of this
prescription. I therefore do not consider it.
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‘‘to verify the information [Respondent]
had provided of not writing any
prescriptions with an expired DEA
number.’’ Tr. 22–23. Moreover, the
evidence clearly shows that what the
ALJ characterized as Respondent’s
‘‘extensive and voluntary disclosures’’
(regarding her failure to create and
maintain treatment records for her
daughter’s prescriptions), were not
made until a subsequent phone call
which occurred after the DI had run the
PMP report. Thus, contrary to the ALJ’s
understanding, it was only after
Respondent was confronted with the
evidence of her misconduct that she
made the admissions regarding her
failure to create records. And even then,
she maintained that she had forgotten
that she had written the March 15
prescription.
Of further note, Respondent
submitted her application three days
after she wrote the prescription and
clearly knew then that her registration
had expired. Moreover, the phone call
in which she denied having written any
prescriptions after the expiration of her
registration occurred in April 2011,
approximately a month (more or less)
after she had written the prescription.12
It simply defies credulity to suggest that
Respondent did not remember having
written the prescription in the
preceding month, especially given that
the prescription was written for her
daughter.13
I therefore conclude that Respondent
knowingly made the false statement to
the investigator. I further conclude that
the false statement was material in that
it had ‘‘‘a natural tendency to influence,
or was capable of influencing, the
decision of’ the decisionmaking body to
which it was addressed.’’ Kungys v.
United States, 485 U.S. 759, 770 (1988)
(quoting Weinstock v. United States, 231
F.2d 699, 701 (D.C. Cir. 1956) (other
citation omitted)) (quoted in Samuel S.
Jackson, 72 FR 23848, 23852 (2007)); see
also United States v. Wells, 519 U.S.
12 In its brief, the Government asserts that the
conversation occurred on April 14, 2011. Gov. Br.
11. Yet the record does not establish anything more
than that it occurred in April 2011. See Tr. 21
(testimony of DI: ‘‘I had a phone conversation with
[Respondent] in April, and we discussed the
licensing information, and at that point, I also asked
[her] if she had prescribed controlled substances to
anyone after the expiration date of her prior
registration.’’); see also id. (Government counsel:
‘‘And do you know the date of this phone call or
approximate date?’’ DI: ‘‘It was in April . . . of
2011.’’).
13 In support of her contention that Respondent
did not deliberately make the false statement, the
ALJ also cited Respondent’s ‘‘credible testimony at
the hearing.’’ R.D. at 18. Yet, Respondent offered no
testimony regarding the circumstances surrounding
her statement. Thus, the ALJ’s finding does not rest
on a credibility determination.
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36589
482, 489 (1997) (quoting Kungys, 485
U.S. at 770). Most significantly for this
proceeding, the Supreme Court has
explained that ‘‘[i]t has never been the
test of materiality that the
misrepresentation or concealment
would more likely than not have
produced an erroneous decision.’’
Kungys, 485 U.S. at 771 (emphasis in
original). Rather, the test is ‘‘whether
the misrepresentation or concealment
was predictably capable of affecting, i.e.,
had a natural tendency to affect, the
official decision.’’ Id.
‘‘‘[T]he ultimate finding of materiality
turns on an interpretation of substantive
law,’’’ id. at 772 (int. quotations and
other citation omitted), and must be met
‘‘by evidence that is clear, unequivocal,
and convincing.’’ Id. That standard is
met here. As explained above, under
federal law, a practitioner cannot
lawfully dispense a controlled
substance unless she possesses a
registration or is otherwise exempt from
registration.14 21 U.S.C. 822(a)(2); 21
CFR 1306.03(a). So too, it is a violation
of federal law for a practitioner to
knowingly use an expired registration to
dispense a controlled substance.15 21
U.S.C. 843(a)(2). Respondent’s false
statement denying that she had issued
any controlled substance prescriptions
after her registration expired was clearly
material under the public interest
standard, because the standard clearly
directs the Agency to consider an
applicant’s ‘‘[c]ompliance with
applicable . . . Federal . . . laws
relating to controlled substances.’’ Id.
§ 823(f)(4).
That the DI made clear that she
intended to obtain a PMP report and
verify the validity of Respondent’s
statement does not make her statement
immaterial. As the First Circuit has
noted with respect to the material
falsification requirement under 18
U.S.C. 1001, ‘‘[i]t makes no difference
that a specific falsification did not exert
influence so long as it had the capacity
to do so.’’ United States v. Alemany
Rivera, 781 F.2d 229, 234 (1st Cir. 1985);
see also United States v. Norris, 749
F.2d 1116, 1121 (4th Cir. 1984) (‘‘There
is no requirement that the false
statement influence or effect the
decision making process of a
14 Respondent makes no argument that she was
exempt from registration at the time she issued the
prescription to her daughter.
15 That in this matter, the Government did not
ultimately prove Respondent knew that her
registration had expired does not make her
statement immaterial. Moreover, at the time of the
statement, Respondent knew her registration had
expired, and that when she issued the prescription,
she did not have authority to do so. 21 CFR
1306.03(a).
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36590
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department of the United States
Government.’’).
To the extent the ALJ’s opinion
suggests that because Respondent, in a
subsequent conversation, admitted to
various other acts (but not to writing a
prescription after her registration
expired), and thus her overall candor
excuses her false statement, I reject it.
Indeed, adopting the ALJ’s reasoning
would create a perverse incentive to
falsely deny the commission of acts
which could result in the denial of one’s
application, in the hope that the
Agency’s investigator would simply take
one at her word. Contrary to the ALJ’s
understanding, there is no free pass for
those who make a false statement during
the course of an Agency investigation,
and those who seek registration from the
Agency have an obligation to provide
truthful answers to all material
questions asked by Agency personnel,
no matter the stage of the investigation.
I therefore conclude that Respondent’s
false statement provides additional
grounds to conclude that her
registration would be inconsistent with
the public interest.16
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Sanction
As found above, while I reject the
Government’s contention that
Respondent lacked a legitimate medical
purpose and acted outside of the usual
course of professional practice in
violation of federal and state law when
she prescribed to her daughter, I
nonetheless find that Respondent
violated federal law when she issued a
controlled substance prescription after
the expiration of her registration and
then made a materially false statement
to the DI when she denied having issued
any such prescriptions after the
expiration of her registration. Had the
proven violations been limited to
Respondent’s issuance of a controlled
substance prescription after the
expiration of her registration, I would
likely have concluded that denial of her
application would be unwarranted. See
Jacobo Dreszer, 76 FR 19386, 19387–88
(2011) (holding that even where the
Government has made out a prima facie
case under the public interest standard,
a respondent can argue that ‘‘his
conduct was not so egregious as to
warrant revocation’’); Gregory D. Owens,
74 FR 36751, 36757 n.22 (2009) (‘‘in
assessing what sanction to impose, the
Agency . . . considers the extent and
egregiousness of a practitioner’s
misconduct.’’).
16 Respondent’s false statement has generally
been considered under factor five, as other conduct
which may threaten public health or safety.
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However, I find that Respondent’s act
in making a materially false statement to
the Investigator constitutes sufficiently
egregious misconduct to support the
denial of her application. I therefore
hold that the Government has satisfied
its prima facie burden of showing that
issuing a new registration to the
applicant would be inconsistent with
the public interest.
As DEA has repeatedly held, upon
this showing, the applicant must then
‘‘present sufficient mitigating evidence’’
to show why she can be entrusted with
a new registration. Medicine ShoppeJonesborough, 73 FR 364, 387 (2008)
(quoting Samuel S. Jackson, 72 FR
23848, 23853 (2007) (quoting Leo R.
Miller, 53 FR 21931, 21932 (1988))).
‘‘Moreover, because ‘past performance is
the best predictor of future
performance,’ ALRA Labs. Inc. v. DEA,
54 F.3d 450, 452 (7th Cir. 1995), [DEA]
has repeatedly held that where a
registrant has committed acts
inconsistent with the public interest, the
registrant must accept responsibility for
[her] actions and demonstrate that [she]
will not engage in future misconduct.’’
Medicine Shoppe, 73 FR at 387; see also
Jackson, 72 FR at 23853; John H.
Kennedy, 71 FR 35705, 35709 (2006);
Cuong Tron Tran, 63 FR 64280, 64283
(1998); Prince George Daniels, 60 FR
62884, 62887 (1995); Hoxie v. DEA, 419
F.3d at 483 (‘‘admitting fault’’ is
‘‘properly consider[ed]’’ by DEA to be
an ‘‘important factor[]’’ in the public
interest determination). So too, in
determining the appropriate sanction,
the Agency has a substantial interest in
deterring future acts of misconduct,
both on the part of a respondent in a
particular case and the community of
registrants. See Joseph Gaudio, 74 FR
10083, 10094 (2009) (quoting
Southwood Pharmaceuticals, Inc., 72 FR
36487, 36504 (2007)); see also Butz v.
Glover Livestock Commission Co., Inc.,
411 U.S. 182, 187–88 (1973); Michael S.
Moore, 76 FR 45867, 45868 (2011).
Here, the ALJ found that ‘‘Respondent
has both taken responsibility for her
actions and shown remorse for her
unlawful conduct.’’ R.D. at 17 (citing Tr.
53, 59). As to the first citation,
Respondent testified regarding her
having been reprimanded, for—in the
words of her counsel—‘‘not filling out
things in a timely basis.’’ Tr. 53. In this
regard, Respondent testified that she
was ‘‘very much scattered’’ and that she
now ‘‘absolutely understand[s] the
gravity of this.’’ Id. The issue, however,
is not whether Respondent timely
completed a renewal application but
why she issued a prescription when she
lacked legal authority to do so and then
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Frm 00085
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Sfmt 4703
falsely denied doing so to the DI.17
Respondent simply offered no testimony
acknowledging that she had violated
federal law when she issued a
prescription after her registration
expired. Nor did Respondent even
address the circumstances surrounding
the false statement she made to the DI.
Accordingly, I reject the ALJ’s finding
that Respondent has accepted
responsibility for her misconduct.
In recommending that I grant
Respondent’s application, the ALJ also
cited various mitigating factors which I
should consider including Respondent’s
health problems (a 2004 heart attack),
her son’s death in a motorcycle accident
(in 2006), and her daughter’s struggle
with mental illness after losing her
health insurance. R.D. at 17. While the
first two events are indisputably tragic,
they do not mitigate Respondent’s
misconduct, which occurred years later.
As for her daughter’s struggle with
mental illness after losing her insurance,
because I find the allegation that
Respondent acted outside of the usual
course of professional practice in
issuing prescriptions to her daughter to
be unsupported by substantial evidence,
I need not decide whether this mitigates
her conduct. However, it clearly does
not mitigate her misconduct in issuing
the prescription after the expiration of
her registration, as the evidence shows
that Respondent’s daughter had
resumed treatment with her psychiatrist
prior to the issuance of the prescription.
Most significantly, it does not excuse
her deliberate and material false
statement to the Investigator. Because
Respondent has failed to acknowledge
her misconduct in making the
statement, I conclude that her
application should be denied. However,
in the event Respondent is willing to
acknowledge her misconduct in making
this statement, favorable consideration
should be granted to a new application
made no earlier than six months from
the date of this Order.
Order
Pursuant to the authority vested in me
by 21 U.S.C. 823(f), as well as 28 CFR
0.100(b), I order that the application of
Belinda R. Mori, N.P., for a DEA
Certificate of Registration as a Mid-Level
Practitioner, be, and it hereby is, denied.
This Order is effective immediately.
17 At Tr. 59, Respondent testified regarding what
she had learned in the class about prescribing for
family members. Respondent is not, however,
required to acknowledge wrongdoing for unproven
misconduct.
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Federal Register / Vol. 78, No. 117 / Tuesday, June 18, 2013 / Notices
Dated: June 9, 2013.
Michele M. Leonhart,
Administrator.
On December 5, 2012, the Deputy
Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration (DEA), issued an Order
to Show Cause to David M. Lewis,
D.M.D. (Registrant), of Sacramento,
California. The Show Cause Order
proposed the revocation of Registrant’s
DEA Certificate of Registration
BL7253115, and the denial of any
pending application to renew or modify
his registration, on the ground that he
lacks authority to handle controlled
substances in California, the State in
which he is registered with DEA. Show
Cause Order at 1 (citing 21 U.S.C. 823(f)
& 824(a)(3)). Show Cause Order at 1.
The Order also alleged that Registrant’s
registration ‘‘will expire by its terms on
March 31, 2013.’’ Id.
Specifically, the Show Cause Order
alleged that on February 24, 2012, the
Dental Board of California suspended
Registrant’s dental license, based ‘‘on
multiple findings’’ that he performed
‘‘unnecessary dental work’’ and filed
‘‘fraudulent insurance claims.’’ Id. The
Order further alleged that as a result of
the suspension, Registrant is without
authority to handle controlled
substances in California, the State in
which he is registered, and therefore,
his registration is subject to revocation.
Id. at 1–2 (citations omitted). The Show
Cause Order also notified Registrant of
his right to request a hearing on the
allegations, or to submit a written
statement in lieu of a hearing, the
procedure for doing either, and the
consequence for failing to do either. Id.
at 2 (citing 21 CFR 1301.43).
According to the declaration of an
Agency Diversion Investigator (DI), on
December 18, 2012, he ‘‘traveled to the
office of Robert Zaro, Esq., who is the
attorney for [Registrant].’’ GX 3, at 1–2.
The DI further stated that ‘‘[a]fter [he]
spoke about the nature of the [Show
Cause Order], Robert Zaro requested to
take possession of the [Order] for his
client.’’ Id. at 2.
Thereafter, on February 8, 2013, the
Government submitted a Request for
Final Agency Action to my Office.
Therein, the Government maintains that
more than thirty days have passed since
the Order ‘‘was served on Respondent
and no request for [a] hearing has been
received.’’ Gov. Req. for Final Agency
Action, at 1. The Government therefore
seeks a final order revoking
Respondent’s registration. Id.
I reject the Government’s request for
two reasons. First, contrary to the
Government’s understanding, it has not
properly served Respondent. Second,
even had I concluded that service was
proper, I would hold that the case is
now moot.
As for whether service was proper, 21
U.S.C. 824(c) provides that ‘‘[b]efore
taking action pursuant to this section
. . . the Attorney General shall serve
upon the . . . registrant an order to
show cause why registration should not
be . . . revoked[] or suspended.’’
(emphasis added). As the DI’s affidavit
makes clear, the Government did not
serve the Show Cause Order ‘‘upon the
. . . [R]egistrant,’’ id., but on an
attorney who, according to the DI, is the
Registrant’s attorney.
However, ‘‘[n]umerous Federal Courts
have held that ‘[t]he mere relationship
between a defendant and his attorney
does not, in itself, convey authority to
accept service.’’’ Harbinson v.
Commonwealth of Virginia, 2010 WL
3655980, at *9 (E.D. Va. Aug. 11, 2010)
(quoting Davies v. Jobs & Adverts
Online, Gmbh, 94 F.Supp.2d 719, 722
(E.D. Va. 2000)). See also United States
v. Ziegler Bolt & Parts Co., 111 F.3d 878,
881 (Fed. Cir. 1997); Grandbouche v.
Lovell, 913 F.2d 835, 837 (10th Cir.
1990); Ransom v. Brennan, 437 F.2d
5134, 518–19 (5th Cir. 1971). ‘‘‘Rather,
the party seeking to establish the agency
relationship must show ‘‘that the
attorney exercised authority beyond the
attorney-client relationship, including
the power to accept service.’’’’’
Harbinson, 2010 WL 3655980, at * 9
(quoting Davies, 94 F.Supp.2d at 722
(quoting Ziegler, 111F.3d at 881)).
While an attorney’s authority to act as
an agent for the acceptance of process
1 Even had I found that the Government properly
served Registrant, I would dismiss this matter as
moot. As noted above, Respondent’s registration
was due to expire on March 31, 2013. Accordingly,
I have taken official notice of the registration
records of this Agency. See 5 U.S.C. 556(e). Those
records show that Registrant’s registration expired
on March 31, 2013, that he did not file a renewal
application (whether timely or not), and that his
registration was retired on May 1, 2013.
It is well settled that ‘‘[i]f a registrant has not
submitted a timely renewal application prior to the
expiration date, then the registration expires and
there is nothing to revoke.’’ Ronald J. Riegel, 63 FR
67132, 67133 (1998); see also William W. Nucklos,
[FR Doc. 2013–14447 Filed 6–17–13; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
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David M. Lewis, D.M.D., Dismissal of
Proceeding
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36591
‘‘may be implied from surrounding
circumstances indicating the intent of’’
his client, In re Focus Media Inc., 387
F.3d 1077, 1082 (9th Cir. 2004) (other
citation and internal quotations
omitted), ‘‘an agent’s authority to act
cannot be established solely from the
agent’s actions.’’ Id. at 1084. ‘‘Rather,
the authority must be established by an
act of the principal.’’ Id. (citing FDIC v.
Oaklawn Apartments, 959 F.2d 170, 175
(10th Cir. 1992)).
Here, the only evidence submitted by
the Government as to whether
Registrant’s attorney was authorized to
accept the Show Cause Order on his
behalf was the DI’s statement that the
attorney requested to take possession of
the Order. In short, the Government
offered no evidence of an act of the
Registrant establishing that he had
granted authority to the attorney to
accept process on his behalf. Focus
Media, 387 F.3d at 1084. Accordingly, I
hold that the Government has not
properly served Registrant. I therefore
reject its request for a final order.1
Order
Pursuant to the authority vested in me
by 21 U.S.C. 824(a), as well as 28 CFR
0.100(b) and 0.104, I order that the
Order to Show Cause issued to David M.
Lewis, D.M.D., be, and it hereby is,
dismissed.
Dated: June 11, 2013.
Thomas M. Harrigan,
Deputy Administrator.
[FR Doc. 2013–14453 Filed 6–17–13; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances;
Notice of Application; Lipomed
Pursuant to Title 21 Code of Federal
Regulations 1301.34 (a), this is notice
that on March 22, 2013, Lipomed, One
Broadway, Cambridge, Massachusetts
02142, made application by renewal to
the Drug Enforcement Administration
(DEA) for registration as an importer of
the following basic classes of controlled
substances:
73 FR 34330 (2008). So too, because Registrant did
not file a renewal application, there is no
application to act upon. See Nucklos, 73 FR at
34330. Accordingly, there is neither a registration,
nor an application, to act upon, and had the
Government properly served Registrant, I would
nonetheless hold that the case is moot.
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Agencies
[Federal Register Volume 78, Number 117 (Tuesday, June 18, 2013)]
[Notices]
[Pages 36582-36591]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-14447]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 12-15]
Belinda R. Mori, N.P.; Decision and Order
On November 17, 2011, the Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement Administration, issued an Order to
Show Cause to Belinda R. Mori, N.P. (Respondent), of Santa Fe, New
Mexico. The Show Cause Order proposed the denial of Respondent's
pending application for a DEA Certificate of Registration, on the
ground that her ``registration would be inconsistent with the public
interest.'' ALJ Ex. 1, at 1.
The Show Cause Order specifically alleged that on March 18, 2011,
Respondent applied for a Certificate of Registration as a mid-level
practitioner, seeking authority to dispense controlled substances in
schedules II through V. Id. The Order further alleged that Respondent
had previously held a registration, which authorized her to dispense
controlled substances in schedules II through V as a mid-level
practitioner but that ``this registration expired on January 31,
2011.'' Id.
Next, the Show Cause Order alleged that ``[b]etween August 29, 2009
and March 15, 2011, [Respondent] issued approximately thirty-three
purported prescriptions for alprazolam (a [s]chedule IV controlled
substance) to [her] daughter without conducting a medical examination
and without creating a patient record,'' and that these prescriptions
``were issued outside the usual course of professional practice, in
violation of Federal and . . . state law.'' Id. (citing 21 CFR
1306.04(a); N.M Admin. Code tit. 16, Sec. Sec. 12.2.7(V) and
12.2.13(N)(5)(g)). The Order further alleged that ``[o]n or about March
15, 2011, [Respondent] issued a purported prescription for alprazolam .
. . to [her] daughter . . . while [she was] without a valid DEA
Certificate of Registration, in violation of Federal and . . . state
law.'' Id. at 2 (citing 21 U.S.C. 841(a)(1); N.M. Admin. Code tit. 16,
Sec. 12.2.13(N)(5)(a)).
On December 5, 2011, Respondent, through her counsel, requested a
hearing on the allegations. ALJ Ex. 2. The matter was placed on the
docket of the Office of Administrative Law Judges (ALJ), and assigned
to an ALJ who proceeded to conduct pre-hearing procedures.
On December 20, 2011, the Government filed its pre-hearing
statement. Therein, the Government provided notice that it intended to
elicit
[[Page 36583]]
the testimony of an Agency Diversion Investigator (DI) that ``on or
about April 14, 2011, she spoke with Respondent about her application
for a DEA Certificate of Registration'' and ``asked Respondent whether
[she] used her previous DEA Certificate of Registration after it
expired, and Respondent stated that she had not.'' Gov't Prehr'g
Statement, at 3. The Government also provided notice that it intended
to show that ``[o]n this same day, [the DI] ran a prescription
monitoring report with the New Mexico Board of Pharmacy for the period
of February 1, 2011, through April 14, 2011, and that the report showed
that Respondent issued one prescription for controlled substances
(alprazolam) after her previous DEA Certificate of Registration
expired,'' and that the prescription was for her daughter and issued
``on or about March 15, 2011.'' Id. Finally, the Government provided
notice that the DI would ``testify that on or about May 3, 2011, she
interviewed Respondent about the alprazolam prescription that was
issued after her previous DEA Certificate of Registration expired,''
and that ``Respondent informed [the DI] that she issued the alprazolam
prescription to her daughter because [she] did not have health
insurance and therefore could not see her treating physician.'' Id.
On May 1, 2012, the ALJ conducted a hearing in Albuquerque, New
Mexico. At the hearing, the Government elicited the testimony of the DI
and introduced various documents into the record; Respondent testified
on her own behalf and also introduced various documents into the
record. Following the hearing, both parties submitted briefs containing
their proposed findings of fact, conclusions of law, and argument.
On July 30, 2012, the ALJ issued her Recommended Decision (R.D.).
Therein, the ALJ found that the Government had proved that Respondent
violated federal law because she issued thirty-three prescriptions to
her daughter and ``did not establish a good faith practitioner-patient
relationship with [her] prior to issuing controlled substance
prescriptions to her.'' R.D. at 16. Moreover, the ALJ found that
Respondent ``violated federal law by issuing a prescription after the
expiration of her DEA Certificate of Registration.'' Id. (citing 21
U.S.C. 843(a)(2)). The ALJ thus concluded that ``in light of
Respondent's serious and undisputed violations of the CSA and New
Mexico law, . . . the Government has presented a prima facie case that
supports the denial of Respondent's application.'' Id. at 16-17.
The ALJ then addressed whether Respondent had rebutted the
Government's prima facie case. R.D. at 17. The ALJ found that
``Respondent has both taken responsibility for her actions and shown
remorse for her unlawful conduct,'' noting that ``she demonstrated
visible remorse for her misconduct'' and ``testified credibly and
candidly about the circumstances surrounding the misconduct.'' Id. She
also explained that Respondent's testimony regarding her ``health
problems,'' the ``death of her son in a motorcycle accident, and her
daughter's subsequent struggle with mental illness after losing her
health insurance'' were ``appropriate mitigating factors'' which should
be considered. Id. at 17-18.
The ALJ further found that although Respondent had made a false
statement to the DI in an April 2011 phone call when she denied writing
any prescriptions after her registration had expired, the ALJ rejected
the Government's contention that she did so deliberately. Id. at 18.
Instead, the ALJ found ``that it is quite plausible that [Respondent]
unintentionally made the false statement,'' reasoning that ``the
Government's argument regarding [her] lack of candor is undercut by the
extensive and voluntary disclosures [she] made to [the DI] during that
April 2011 telephone conversation, namely that she had not prepared or
maintained any treatment records regarding these prescriptions.'' Id.
The ALJ thus reasoned that ``[i]n light of the totality of [her]
interaction with [the DI] and her credible testimony at the hearing, .
. . her statement, while admittedly false, does not negatively outweigh
her overall candor with the Agency.'' Id.
Next, the ALJ found ``that Respondent has demonstrated specific
remedial measures which she has undertaken to prevent the reoccurrence
of her unlawful conduct,'' including her completion of ``a continuing
medical education class on prescribing for family members'' and that
she ``has pledged to cease writing prescriptions for her daughter or
any other family member.'' Id. at 19. The ALJ further noted that
Respondent had discussed her daughter's treatment with her psychiatrist
and confirmed that all of her daughter's prescriptions would henceforth
be issued by him. Id.
The ALJ thus concluded that the Government's proposed sanction of
denial would be ``too severe.'' Id. While finding that Respondent's
``misconduct was . . . serious,'' the ALJ recommended that Respondent
be granted a restricted registration, concluding that she ``has now
demonstrated that she understands the responsibilities and requirements
of a DEA registrant.'' Id. at 19-20.
Having considered the record in its entirety, I adopt the ALJ's
findings of fact and conclusions of law except as discussed below.
While I reject the ALJ's finding that Respondent violated the CSA's
prescription requirement when she prescribed to her daughter as
unsupported by substantial evidence, I adopt her finding that
Respondent violated DEA regulations when she prescribed a controlled
substance after the expiration of her registration. I further reject
the ALJ's finding that Respondent unintentionally made a false
statement to the DI when she denied having written any controlled
substance prescriptions after the expiration of her DEA registration.
Because Respondent has failed to accept responsibility for her
misconduct, I reject the ALJ's recommended sanction and will order that
Respondent's application be denied.
Findings of Fact
Respondent is a Certified Nurse Practitioner licensed by the Board
of Nursing for the State of New Mexico. GX 3, at 3. On June 23, 2010,
the Executive Director of the Board of Nursing (Board) notified
Respondent that she had reviewed evidence suggesting that Respondent
had practiced on an expired license (and thus practiced without a
license). GX 4, at 1. While the Executive Director noted that ``there
is sufficient evidence for the Board to consider disciplinary actions
against [Respondent's] nursing license,'' the Board offered Respondent
a ``voluntary reprimand and fine.'' Id., see also GX 4, at 3. On July
2, 2010, Respondent accepted the reprimand, id. at 2, and in December
2010, the Board issued her a Voluntary Letter of Reprimand. GX 5.
Respondent also previously held a DEA Certificate of Registration,
which authorized her to dispense controlled substances in schedules II
through V, as a mid-level practitioner, at the registered address of
3715 Southern Blvd., Rio Rancho, New Mexico. GX 2, at 1. On January 31,
2011, the registration expired. Id. Thereafter, ``no controlled
substances could be obtained, stored, administered, prescribed, or
dispensed under'' the registration. Id. Respondent did not submit a
renewal application until March 18, 2011. Id.
At some point not clear on the record, but after Respondent
submitted her renewal application, Respondent called the DEA Office in
Albuquerque regarding the status of her application. Tr. 16. The DI who
was assigned the weekly duty of taking phone calls subsequently
returned her call and
[[Page 36584]]
explained that her application had yet to be assigned to an
investigator, but that it would be and that an investigator would
contact her for further information. Id.
The DI testified that before she returned Respondent's phone call,
she had determined that Respondent had previously held a DEA
registration.\1\ Id. at 17. The DI also testified that before she
returned Respondent's call, she had queried the Board of Nursing's Web
site and noted that Respondent had been reprimanded by the Board. Id.
---------------------------------------------------------------------------
\1\ According to the DI, at the time of her first phone call
with Respondent, the matter had yet to be assigned to an
Investigator. However, the matter was eventually assigned to the DI.
The record is less than transparent regarding whether at the time of
the DI's initial phone call with Respondent she had queried the
State Board's Web site as well as determined that Respondent had
previously been registered or whether she made these inquiries prior
to a second phone conversation.
---------------------------------------------------------------------------
During the phone call, the DI verified with Respondent that she had
previously held a registration. Id. The DI also told Respondent that as
part of the pre-registration investigation, she would be contacting the
Board for more information regarding the basis of the reprimand. Id.
She then discussed with Respondent the reason for having to submit a
new application. Respondent told the DI that her registration had
expired because she had failed to renew it. Id. at 22.
The DI asked Respondent if she had written any prescriptions past
the expiration date; Respondent ``stated she had not.'' Id. The DI then
told Respondent that she ``would be running a prescription monitoring
program report [PMP]'' and ``explained to [her] what the PMP was and
what it would show me.'' Id. The DI told Respondent that the PMP
``would show the prescriptions that were filled pursuant to her DEA
number for a certain time period,'' id, and ``explained that [she]
would be querying that to verify the information she had provided of
not writing any prescriptions with an expired DEA number.'' Id. at 23.
Subsequently, the DI ran the PMP from August 1, 2009 through August
5, 2011. Id. at 23; GX 6. The DI testified that ``the document shows .
. . that Ms. Mori had self-prescribed a controlled substance in August
of 2009, and also that there was a patient by the name of Mia Mori who
had a prescription written and filled on March 15 of 2011.'' Id.; GX 6,
at 1. The DI testified that the report listed additional prescriptions
written by Respondent for Mia Mori, which were for two schedule IV
controlled substances, alprazolam and zolpidem, and which were written
between August 29, 2009 through March 15, 2011. Id. at 24-25; GX 6, at
1-3. The PMP report also shows that on August 12, 2009, Respondent
self-prescribed thirty tablets of zaleplon 10 mg, a schedule IV
controlled substance. GX 6, at 1; 21 CFR 1308.14(c)(51).
The DI then testified that Respondent's DEA registration had
expired on January 31, 2011. Id. at 25. She also reiterated that
Respondent had not told her about the March prescription when she spoke
to her in April 2011. Id.
Next, the DI testified regarding the process for renewing a
registration and the procedures used by the Agency to notify a
registrant regarding an impending expiration. More specifically, the DI
explained that a DEA registration does not renew automatically, and
that a ``renewal application . . . has to be submitted by the
registrant, asking for a renewal of the number.'' Id. The DI further
explained that the expiration date is printed on the face of the
registration certificate, and that ``the [Agency's] registration unit .
. . automatically generates two notices before the expiration, advising
[the registrant that] you're coming close to the expiration date.'' Id.
at 25-26. According to the DI, if a registration ``actually does expire
before it is renewed . . . a delinquency notice is mailed out to the
registered address of the registrant.'' Id. at 26.
The DI testified that after she discovered the March 15, 2011
prescription, she spoke again with Respondent by telephone. The DI
explained to Respondent that she had run the PMP report and that there
were three prescriptions filled after the expiration date which were
written prior to the expiration date, and one prescription that was
written after the expiration date that was also filled. Id. at 26.
Regarding these prescriptions, the DI testified that Respondent told
her ``that Mia Mori was her daughter and that she had written the
prescription after her daughter had lost her health insurance, and that
she had forgotten to advise me of that.'' Id. at 26-27. Respondent told
the DI ``that her daughter had seen a psychiatrist'' and that she was
``treating her daughter's anxiety and that was why she had prescribed
the alprazolam to her.'' Id. at 27.
The DI then asked Respondent to meet her and bring her daughter's
patient chart for review. Id. Respondent told the DI that she had not
created a patient chart for her daughter, and that she did not maintain
any records regarding periodic evaluations of her daughter to determine
whether her treatment was proceeding as it should. Id. at 27-28.
Moreover, when asked by the Government's counsel if she knew if
Respondent ``was conducting a medical examination of any sort,'' the DI
answered that she did ``not know.'' Id. at 28.
The DI ran another PMP report using Mia Mori's name; the report
covered the period from January 2006 through December 8, 2011. GX 7.
The report shows that Respondent first began prescribing to her
daughter in April 2007; the first prescription was for hydrocodone with
acetaminophen, a schedule III controlled substance. Tr. 29; GX 7, at 2.
The report also shows that Respondent wrote multiple prescriptions
for her daughter for both zolpidem and alprazolam. These include
prescriptions for 90 tablets of zolpidem 10 mg on July 28 and October
17, 2007, as well a prescription for 30 tablets of zolpidem 10 mg on
August 29, 2009, which was refilled on September 26, 2009. GX 7, at 2.
As for the alprazolam prescriptions, on October 23, 2009,
Respondent wrote a prescription for 30 tablets of alprazolam 0.5 mg;
this prescription was refilled on November 8, 18, and 29. Id. On
December 9, 2009, Respondent wrote a prescription for her daughter for
60 tablets of alprazolam 0.5 mg; this prescription was refilled on
December 28 and January 14, 2010. Id. This was followed by a February
3, 2010 prescription for 30 tablets of alprazolam 0.5 mg, which was
refilled on February 12, 22, and March 3, 2010; as well as another
prescription for 30 tablets of alprazolam 0.5 mg on March 14, 2010
(which was not filled until March 25, 2010). Id.
On April 15, 2010, Respondent wrote another prescription for 60
tablets of alprazolam 0.5 mg, which was refilled on May 20, June 15,
and July 2, 2010. Id. This was followed by prescriptions for 30 tablets
of alprazolam 0.5 mg on July 28, 2010 (which was refilled on August 9,
19, and 29), on September 8, 2010 (which was refilled on September 20,
October 4, 15 and 27), and on January 14, 2011 (which was refilled four
times through March 6, 2011). Respondent wrote a final prescription for
30 alprazolam 0.5 mg for her daughter on March 15, 2011, which was 43
days after her DEA registration had expired. Id.
The DI testified that the 2007 prescriptions were noteworthy
because Respondent's daughter turned twenty-two in 2009, and the DI's
understanding was that she had lost her health insurance upon reaching
this age. Tr. 29. The DI stated that ``based on the information that
[Respondent] provided,
[[Page 36585]]
her daughter would have had health insurance'' in 2007. Id. at 29-30.
The DI continued her investigation by contacting the pharmacies
listed as having filled the controlled substances and asking them to
pull the original prescriptions, the signature log, and the method of
payment for those prescriptions. Id. at 31. Those documents indicated
that each of those prescriptions was called in by Respondent for her
daughter, and that Mia Mori had picked up the prescriptions. Id.
The DI testified that Respondent issued her daughter a total of
thirty-three controlled substance prescriptions. Id. Of these, eleven
were original prescriptions; the other twenty-two were refills. Id.
The DI testified that she provided a copy of her report to the New
Mexico Board of Nursing, and that after the report was forwarded to the
Board, it initiated a complaint and subsequently took action against
Respondent's nursing license. Id. at 32. This resulted in a Settlement
Agreement between the Board and Respondent in December 2011. Id. at 33-
34; RX 4, at 2. Under the Settlement Agreement, Respondent received a
letter of reprimand and was required to complete a continuing education
course in patient/physician/family caregiver relationships. RX 4, at 2.
Respondent completed the course in December 2011. Id. at 5.
Respondent testified that in 2004, after being released from active
duty in the army, she had suffered a heart attack, and that about a
year and a half later, her son was killed in a motorcycle accident. Tr.
53. Shortly thereafter, her daughter complained that ``she was going
crazy'' and ``needed to see a psychiatrist.'' Id. at 53-54. Respondent
stated that she took her daughter to a psychiatrist, who diagnosed her
with ``severe anxiety disorder with an OCD component.'' Id. at 54.
Subsequently, the psychiatrist recommended that Respondent's daughter
see a specialist in OCD, and so she began treating with a Dr. Summers.
Id.
When asked by her counsel as to why she had written her daughter
prescriptions for Abilify (a non-controlled prescription drug) and
alprazolam, Respondent testified that her daughter's OCD causes
thoughts of self-harm, and she wanted to ensure that her daughter was
mentally stable. Id. Respondent testified that she ``could not lose
another child.'' Id.
Respondent then testified regarding several other prescriptions she
had issued for her daughter. Specifically, Respondent testified that
she prescribed Ambien (zolpidem) for her daughter on two occasions,
including on August 29, 2009 (as well as on another date which she did
not recall) because ``she was unable to sleep at all.'' Id. at 55. See
also GX 7, at 2 (zolpidem prescriptions issued on 7/28/07 and 10/16/
07). Respondent testified that Ambien had been prescribed for her
daughter by her treating physicians, but did not state when or by whom
specifically.\2\ Id. at 56. Respondent testified that she also wrote
her daughter a prescription for Percodan on April 21, 2007, when she
had inflamed tonsils. Id. at 58.
---------------------------------------------------------------------------
\2\ Other evidence corroborates Respondent's testimony that
Ambien had been prescribed to her daughter on multiple occasions by
a Dr. D.R., beginning in May 2006. GX 7, at 2.
---------------------------------------------------------------------------
Respondent stated that one of the reasons she wrote the
prescriptions for her daughter was because she ``did not have insurance
and the cost of the drugs,'' and ``to maintain her sanity, so that she
would not commit suicide.'' Id. However, when the Government asked
Respondent if her daughter had been diagnosed as suicidal, she stated:
``I have not read her records.'' Id. at 61. Moreover, Respondent's
evidence shows that her daughter resumed treatment with her
psychiatrist on January 13, 2011. RX 3, at 11. Yet the next day,
Respondent issued to her daughter another prescription for thirty
alprazolam with four refills. GX 8, at 40. Moreover, on March 15, 2011,
Respondent issued another prescription for thirty alprazolam, which
also authorized multiple refills. GX 8, at 45. Respondent offered no
explanation as to why she issued these prescriptions when her daughter
had resumed seeing her psychiatrist.
Respondent was also asked whether she looked into care alternatives
when she knew her daughter would not be able to continue seeing her
doctor. Id. at 62. Respondent first stated she did not, but then
changed her response to ``yes.'' Id. Respondent then testified that
there were neither free therapy services nor group therapy sessions
available for her daughter, and that because she was stable, she
decided to just continue her on the medication. Id. Respondent then
admitted that when she informed the doctor that her daughter no longer
had health insurance, he did not immediately cease all ties with her.
Id. at 63. When asked whether she had developed a treatment plan with
her daughter's psychiatrist for the period when her daughter did not
have health insurance, Respondent replied that the psychiatrist had
already created a treatment plan. Id.
Regarding the prescriptions she issued her daughter, Respondent
also introduced several exhibits. The first of these is an affidavit by
her daughter's psychiatrist, who stated that he had treated her
daughter from April 2006 through 2011, and that he had diagnosed her
with ``an anxiety disorder and secondary depression due to obsessive
compulsive neurosis.'' RX 1. The psychiatrist stated that he had
prescribed Abilify and alprazolam to Respondent's daughter. Id. The
psychiatrist further stated that it was his understanding that ``due to
insurance concerns,'' Respondent had ``actually filled out
prescriptions for her daughter from the time frame of August 2010
through March 2011 \3\,'' and that ``[s]uch prescriptions would have
been in conformance with my desired treatment including drugs ordered,
strength indicated, and number of pills to be given.'' Id. Finally, the
psychiatrist expressed his belief that the ``prescriptions were written
in conformance with my treatment and do not indicate any prescription
regime that was not recommended by me.'' Id. Yet, the psychiatrist did
not address why Respondent had continued to prescribe alprazolam after
her daughter had resumed treatment with him.
---------------------------------------------------------------------------
\3\ In a letter written by the psychiatrist to Respondent's
counsel approximately one week before he executed his affidavit, the
psychiatrist stated that ``[a]pparently, in 2009[,] she
[Respondent's daughter] was unable to afford health insurance. She
was lost to follow-up until January 2011.'' RX 2, at 1. In resolving
the apparent conflict between the dates during which Respondent's
daughter lacked insurance, I give no weight to the psychiatrist's
letter (which is unsworn) and rely solely on the affidavit.
---------------------------------------------------------------------------
Regarding the prescribing class the Board required her to take,
Respondent testified that ``it's common practice that is not well
established to not prescribe for your family members, and that this is
a real issue.'' Id. at 59. She further testified that she understood
that she can never again prescribe to a family member. Id. And when
asked by the ALJ if she had issued any prescriptions to her daughter
since taking the class on prescribing to family members, Respondent
answered ``absolutely not.'' Id. at 66.
Respondent also acknowledged that in December 2010, the State Board
issued her a reprimand for not renewing her state license in a timely
manner. Id. at 64-65. When the Government asked if it was correct that
she then let her DEA registration lapse in January 2011, Respondent
replied:
Well, I didn't let it. I just was unaware of the expiration, and
I didn't know this until I started refilling my New Mexico pharmacy
license, where they require you to put in the expiration of your
DEA. At that point, I
[[Page 36586]]
called the DEA in El Paso, to ask them when that was, and that's how
I found out. . . .
Id. at 64. Respondent admitted that notwithstanding having been
reprimanded for not renewing her state license in a timely manner, she
did not then check her DEA registration to determine if it was going to
expire soon. Id. at 65. Indeed, she described herself as being ``very
much'' scattered during the previous five years with regard to filing
the renewals for her various licenses on time. Id. at 53. However, in
response to a series of questions regarding whether she now understood
the importance of keeping her licenses current, Respondent testified
that she ``understood the gravity'' of the situation, id., and on
cross-examination, she testified that she had recently renewed her
pharmacy license and had ``sent it in early.'' Id. at 66.
Discussion
Section 303(f) of the Controlled Substances Act (CSA) provides that
the Attorney General ``may deny an application for [a practitioner's]
registration if he determines that the issuance of such a registration
is inconsistent with the public interest.'' 21 U.S.C. 823(f). In making
the public interest determination, the CSA directs that the following
factors be considered:
(1) The recommendation of the appropriate State licensing board
or professional disciplinary authority.
(2) The applicant's experience in dispensing . . . controlled
substances.
(3) The applicant's conviction record under Federal or State
laws relating to the manufacture, distribution, or dispensing of
controlled substances.
(4) Compliance with applicable State, Federal, or local laws
relating to controlled substances.
(5) Such other conduct which may threaten the public health and
safety.
Id.
``[T]hese factors are . . . considered in the disjunctive.'' Robert
A. Leslie, M.D., 68 FR 15227, 15230 (2003). It is well settled that I
``may rely on any one or a combination of factors, and may give each
factor the weight [I] deem[] appropriate in determining whether a
registration should be revoked.'' Id.; see also MacKay v. DEA, 664 F.3d
808, 816 (10th Cir. 2011); Volkman v. DEA, 567 F.3d 215, 222 (6th Cir.
2009); Hoxie v. DEA, 419 F.3d 477, 482 (6th Cir. 2005). Moreover, while
I am required to consider each of the factors, I ``need not make
explicit findings as to each one.'' MacKay, 664 F.3d at 816 (quoting
Volkman, 567 F.3d at 222); see also Hoxie, 419 F.3d at 482.\4\
---------------------------------------------------------------------------
\4\ In short, this is not a contest in which score is kept; the
Agency is not required to mechanically count up the factors and
determine how many favor the Government and how many favor the
registrant. Rather, it is an inquiry which focuses on protecting the
public interest; what matters is the seriousness of the registrant's
misconduct. Jayam Krishna-Iyer, 74 FR 459, 462 (2009). Accordingly,
as the Tenth Circuit has recognized, findings under a single factor
can support the revocation of a registration. MacKay, 664 F.3d at
821. Likewise, findings under a single factor can support the denial
of an application.
---------------------------------------------------------------------------
The Government has ``the burden of proving that the requirements
for . . . registration . . . are not satisfied.'' 21 CFR 1301.44(d).
However, where the Government has met its prima facie burden of showing
that issuing a new registration to the applicant would be inconsistent
with the public interest, an applicant must then ``present sufficient
mitigating evidence'' to show why she can be entrusted with a new
registration. Medicine Shoppe-Jonesborough, 73 FR 364, 387 (2008)
(quoting Samuel S. Jackson, 72 FR 23848, 23853 (2007) (quoting Leo R.
Miller, 53 FR 21931, 21932 (1988))).
In this matter, while I reject the ALJ's conclusion that Respondent
violated 21 U.S.C. 843(a)(2), I find Respondent violated DEA
regulations when she issued a controlled substance prescription when
she was not registered to do so. Accordingly, I agree with the ALJ's
conclusion that factors two (Respondent's experience in dispensing
controlled substances) and four (Respondent's compliance with
applicable laws related to controlled substances) support the denial of
Respondent's application. R.D. at 16-17. However, with respect to
factor five, I reject the ALJ's conclusion that Respondent did not
intentionally make a false statement to the DI when she denied having
written any controlled substance prescriptions after her registration
expired. Moreover, I reject the ALJ's conclusion that Respondent has
``both taken responsibility for her actions and shown remorse for her
misconduct.'' Id. at 17. Indeed, Respondent offered no remorse for her
misconduct in prescribing to her daughter after her registration
expired. Nor did she offer any testimony addressing the materially
false statement she made to the DI when she denied writing controlled
substance prescriptions after the expiration of her registration.\5\
---------------------------------------------------------------------------
\5\ As for factor one, I acknowledge that Respondent holds the
requisite New Mexico certified nurse practitioner and controlled
substance licenses. However, there is no ``recommendation'' one way
or the other from the various state authorities as to whether
Respondent's application should be granted.
While the possession of state authority to dispense controlled
substances is a prerequisite for obtaining and maintaining a DEA
registration, the CSA vests this Agency with ``a separate oversight
responsibility [apart from that which exists in state authorities]
with respect to the handling of controlled substances.'' Mortimer B.
Levin, 55 FR 8209, 8210 (1990). DEA has therefore long recognized
that it has ``a statutory obligation to make its independent
determination as to whether the granting of [a registration] would
be in the public interest.'' Id. Thus, while Respondent satisfies
this prerequisite for obtaining registration, this factor is not
dispositive of the public interest inquiry. Id. (holding that
practitioner's reinstatement by state board ``is not dispositive''
in public interest inquiry).
As for factor three, while a history of criminal convictions
for offenses involving the distribution or dispensing of controlled
substances is a highly relevant consideration in the public interest
inquiry, there are any number of reasons why a registrant may not
have been convicted of such an offense, and thus, the absence of
such a conviction is of considerably less consequence. Jayam
Krishna-Iyer, 74 FR 459, 461 (2009). Accordingly, that Respondent
has not been convicted of an offense related to the distribution or
dispensing of a controlled substance is also not dispositive of
whether granting her application ``is consistent with the public
interest.'' 21 U.S.C. 823(f); Krishna-Iyer, 74 FR at 461.
---------------------------------------------------------------------------
Factors Two and Four--Respondent's Experience in Dispensing Controlled
Substances and Compliance With Applicable Laws Related to Controlled
Substances
Under a longstanding Agency regulation, ``[a] prescription for a
controlled substance [is not] effective [unless it is] issued for a
legitimate medical purpose by an individual practitioner acting in the
usual course of [her] professional practice.'' 21 CFR 1306.04(a). This
regulation further provides that ``an order purporting to be a
prescription issued not in the usual course of professional treatment .
. . is not a prescription within the meaning and intent of [21 U.S.C.
Sec. 829] and . . . the person issuing it, shall be subject to the
penalties provided for violations of the provisions of law relating to
controlled substances.'' Id.; see also 21 U.S.C. 802(10) (defining the
term ``dispense'' as meaning ``to deliver a controlled substance to an
ultimate user by, or pursuant to the lawful order of, a practitioner,
including the prescribing and administering of a controlled
substance'') (emphasis added).
As the Supreme Court recently explained, ``the prescription
requirement . . . ensures patients use controlled substances under the
supervision of a doctor so as to prevent addiction and recreational
abuse. As a corollary, [it] also bars doctors from peddling to patients
who crave the drugs for those prohibited uses.'' Gonzales v. Oregon,
546 U.S. 243, 274 (2006) (citing United States v. Moore, 423 U.S. 122,
135, 143 (1975)).
Under the Controlled Substances Act, ``it is fundamental that a
practitioner must establish a bona fide doctor-patient relationship in
order to act `in
[[Page 36587]]
the usual course of professional practice' and to issue a prescription
for a legitimate medical purpose.'' Patrick W. Stodola, 74 FR 20727,
20731 (2009) (citing Moore, 423 U.S. at 141-43). The CSA generally
looks to state law and medical practice standards to determine whether
a practitioner has established a valid practitioner-patient
relationship. See United Prescription Services, Inc., 72 FR 50397,
50407 (2007) (citation omitted); but see 21 U.S.C. 829(e).
Under New Mexico regulations, a Certified Nurse Practitioner (CNP)
who has ``fulfilled the requirements for prescriptive authority may
prescribe and distribute dangerous drugs including controlled
substances . . . within [her] clinical specialty and practice
setting.'' N.M. Code Sec. 16.12.2.13N(5). These regulations further
provide that a CNP ``may prescribe, provide samples of and dispense any
dangerous drug to a patient where there is a valid practitioner-patient
relationship as defined in'' N.M. Code Sec. 16.12.2.7. The latter
provision defines a ``valid practitioner-patient relationship'' as:
a professional relationship between the practitioner and the patient
for the purpose of maintaining the patient's well-being. At minimum,
this relationship is an interactive encounter between the
practitioner and patient involving an appropriate history and
physical or mental examination, ordering labs or diagnostic tests
sufficient to make a diagnosis and providing, prescribing or
recommending treatment, or referring to other health care providers.
A patient record must be generated by the encounter.
Id. Sec. 16.12.2.7.V.
Based on this regulation, the Government argues that Respondent
violated both federal and state law when she prescribed controlled
substances such as alprazolam and Ambien (zolpidem) to her daughter
because she ``kept no prescription records, kept no patient charts, and
performed no physical or mental examinations.'' Gov't Br. 8. It further
argues that ``[a] practitioner is not excused from establishing a valid
[practitioner]-patient relationship simply because another practitioner
has previously established a valid relationship and the course of
prescribed controlled substances is the same as with the prior
practitioner.'' Id. at 7 (citing Randall L. Wolff, 77 FR 5106 (2012)).
With respect to the latter contention, the Government argues that the
psychiatrist's ``post-approval of the program, [in] an attempt to bring
validity to the prescriptions[,] instead reveals two New Mexico
practitioners ignoring or unaware of the simple fact that a doctor-
patient relationship is not transferrable.'' Id. at 8 (citations
omitted).
As support for its contention that Respondent ``performed no
physical or mental examinations,'' the Government cites the DI's
testimony. Gov't Br. 4 (citing Tr. 27-28). However, while the DI
testified that Respondent indicated ``that she had never made a patient
chart for her daughter'' or provided her ``with any prescription
records,'' id. (citing Tr. 27), on the issue of whether Respondent had
examined her daughter, the DI's testimony lacked probative force.
More specifically, when asked if Respondent told her ``about
weekly, monthly sessions of meeting with her daughter to diagnose or to
make sure the treatment was proceeding as it should,'' the DI
testified: ``No, she did not.'' Tr. 27. When the Government followed up
by asking the DI if she knew ``why [Respondent] didn't provide you with
any of that information?'' the DI testified: ``Because she stated she
had not maintained any of those documents.'' Id. And when asked ``do
you know if she [Respondent] was conducting a medical examination of
any sort?,'' the DI testified: ``No, I do not know.'' Id. at 28.
Significantly, at no point did the Government ask the DI if she had
specifically asked Respondent whether she had examined her daughter or
had performed periodic evaluations of her and been told that she had
not. Nor, during Respondent's testimony, did the Government ask her if
she had examined her daughter or performed periodic evaluations of
her.\6\
---------------------------------------------------------------------------
\6\ There is evidence that Respondent practiced at a med spa.
See GX 1 (Respondent's application); Tr. 52 (Respondent's testimony
that in 2006, she had ``moved into the medical aesthetics
industry''). However, while New Mexico's regulations limit a CNP's
prescribing authority to ``their clinical specialty and practice
setting,'' N.M. Code Sec. 16.12.2.13N(5), and it seems most
unlikely that prescribing for psychiatric conditions was within
Respondent's clinical specialty, the Government made no such
contention.
---------------------------------------------------------------------------
To be sure, there are cases in which evidence that a practitioner
failed to create medical records has given rise to the inference that
the practitioner failed to perform those tasks (such as taking the
necessary history and performing an appropriate examination) which are
essential for properly diagnosing and periodically re-evaluating her
patient. Yet this case stands on a substantially different footing than
those cases, because even if it is not within professional ethics for a
Nurse Practitioner to prescribe to a family member,\7\ the evidence is
undisputed that Respondent was intimately involved in her daughter's
wellbeing and the decision to seek psychiatric care. Thus, while
Respondent may not have documented a history of her daughter's
psychiatric condition, she was obviously well aware of her daughter's
condition. So too, she was well aware of her daughter's diagnosis and
her response to treatment. And significantly, upon resuming active
treatment of Respondent's daughter, her psychiatrist made the same
assessment of her condition and continued to prescribe alprazolam to
her. See RX 3, at 9-10.
---------------------------------------------------------------------------
\7\ It is noted that the State Board required Respondent to take
a course in ``patient/physician/family caregiver relationships.'' RX
4, at 2. While it seems unlikely that the Board would have required
Respondent to take this course if prescribing to a family member was
not a violation of professional standards, the Board's Order
contains no reference to any such standard. See generally RX 4. Nor
does the Government cite to any New Mexico statute, board
regulation, policy statement, or decision (of either the Board or
state courts) holding that prescribing to family members exceeds the
bounds of professional practice. It also did not sponsor any expert
testimony on the issue.
In her decision, the ALJ sidestepped the issue of the adequacy
of the Government's proof, reasoning that ``[t]he parties
acknowledge that [Respondent] violated both federal and state law
when she issued the thirty-three prescriptions to'' her daughter.
R.D. at 16 (citing, inter alia, Tr. 45). However, the cited portion
of the transcript was simply the opening statement of Respondent's
counsel and not testimony. Therein, Respondent's counsel stated:
``Should she have written prescriptions for her daughter? The answer
is, no, she shouldn't have.'' Tr. 45.
Moreover, even were I to treat this statement as evidence,
there are many things that people do that they shouldn't do. But
that does not necessarily make the particular act a violation of a
law or regulation. Given that the State Board required Respondent to
take a course in prescribing to family members, Respondent may well
have recognized that doing so was unethical or constituted
malpractice. While Respondent testified that prescribing to family
members ``is a real issue,'' Tr. 59, on cross-examination, the
Government did not ask Respondent why she now recognized that doing
so ``is a real issue'' or why she should not have written the
prescriptions, and in any event, her acknowledgement does not
constitute an admission that her ``actions completely betrayed any
semblance of legitimate medical treatment'' and thus constituted
drug dealing. United States v. Feingold, 454 F.3d 1001, 1010 (9th
Cir. 2006).
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As noted above, the Government also cites the Agency decision in
Wolff, to argue that a ``doctor-patient relationship is not
transferrable'' and that Respondent ``ignor[ed] clear laws that make
such transference of the doctor-patient relationship a violation.''
Gov't Br. 8. The Government ignores that the decision in Wolff
specifically cited the testimony of an expert witness that it was not
``within the standard of care'' in the State where Dr. Wolff practiced
``for a physician to `perpetuate[] the issuance of controlled
substances ordered by another doctor without first establishing his own
valid doctor-patient relationship.' '' 77 FR at 5107 n.2. Contrary to
the Government's
[[Page 36588]]
understanding, neither the CSA, nor Agency regulations, address the
issue of whether, and under what circumstances, a prescriber-patient
relationship is transferable. Rather, this is an issue which can be
decided only by reference to the standards adopted by the New Mexico
authorities and the accepted standards of professional practice. Here,
however, the Government cites to no state authority (whether a statute,
regulation, administrative or judicial decision, or policy statement)
to support its contention that Respondent violated ``clear laws.'' Nor
did it offer any expert testimony to this effect.
Thus, while Respondent's failure to create a patient record for her
daughter provides some evidence that Respondent lacked a legitimate
medical purpose in prescribing alprazolam to her daughter, I conclude
that the record as a whole does not support a finding that she violated
the CSA's prescription requirement.\8\ As for whether her failure to
create a patient record is, by itself, sufficient to establish that she
prescribed without a valid practitioner-patient relationship under New
Mexico law, I conclude that that was a matter for state authorities. In
short, I conclude that the Government's evidence establishes only that
Respondent did not create state-required medical records. See N.M. Code
Sec. Sec. 16.12.2.7.V, 16.12.2.13.N(5)(g).
---------------------------------------------------------------------------
\8\ It is also noted that the Government makes no claim that the
drugs Respondent prescribed to her daughter were being abused or
diverted to others.
---------------------------------------------------------------------------
The Government's evidence does, however, establish that
Respondent's registration expired on January 31, 2011, GX 2, and that
on March 15, 2011, Respondent issued her daughter another prescription
for alprazolam. See GX 7, at 1; GX 8, at 45. Under federal law, it is
``unlawful for any person knowingly or intentionally . . . to use in
the course of the . . . dispensing of a controlled substance, . . . a
registration number which is . . . expired.'' 21 U.S.C. 843(a)(2).
Regarding this violation, the DI testified that the expiration date
of a registration ``is printed on the certificate'' and that the
Agency's registration unit ``automatically generates two notices before
the expiration'' advising a registrant of the impending expiration. Tr.
25-26. The DI also testified that after the expiration of a
registration, a delinquency notice is also mailed to the registrant.
Id. at 26. Respondent's registration was not ``retired from the DEA
computer system [until] March 1, 2011.'' GX 2, at 1. However, the
Government offered no evidence that these notices were actually mailed
to Respondent, let alone evidence as to what address they were sent.\9\
---------------------------------------------------------------------------
\9\ According to the Government's evidence, Respondent was
registered at the address of PMG GI, 3715 Southern Blvd., Rio
Rancho, New Mexico. GX 2, at 1. However, on her application,
Respondent listed her proposed registered address as Eden Medspa,
405 Kiva Court, Santa Fe, New Mexico. GX 1, at 1. Under federal law,
``[e]very registrant . . . shall be required to report any change of
professional or business address in such manner as the Attorney
General shall by regulation require.'' 21 U.S.C. 827(g); see also 21
CFR 1301.51 (providing procedure for modifying address). While
Respondent was required to inform the Agency that she had changed
her address and modify her registration, no such allegation was
raised by the Government. Moreover, no evidence was adduced as to
whether her mail had been forwarded to her by the clinic listed on
her expired registration.
---------------------------------------------------------------------------
At the hearing, Respondent asserted that she ``was just unaware of
the expiration'' of her registration, and ``didn't know this until
[she] started refilling [sic] [her] New Mexico pharmacy license, where
they require you to put in the expiration of your DEA.'' Tr. 64. She
further asserted that notwithstanding the reprimand she had received in
late December 2010 for practicing nursing without a license, she did
not check her DEA registration to see if it was due to expire soon. Id.
at 65. The Government did not, however, ask Respondent when she had
filled out her pharmacy license application, or introduce any
documentary evidence establishing the date on which she did this.
Notwithstanding Respondent's testimony (which the ALJ found to be
credible) that she was unaware of the expiration of her registration,
the ALJ found that Respondent ``violated federal law by issuing a
prescription after the expiration of her'' registration. R.D. at 16
(citing 21 U.S.C. 843(a)(2)). However, as explained above, establishing
a violation of section 843(a)(2) requires proof that Respondent
knowingly issued the prescription after the expiration of her
registration. As the D.C. Circuit has explained, to establish
knowledge, the Government must either prove that when she wrote the
March 15, 2011 prescription, Respondent had actual knowledge that her
registration had expired or that she was willfully blind or
deliberately indifferent to that fact that her registration had
expired. Cf. United States v. Alston-Graves, 435 F.3d 331 (D.C. Cir.
2006). However, if Respondent ``act[ed] through ignorance, mistake or
accident,'' id. at 337, she did not act with the requisite knowledge.
Here, the ALJ found Respondent's testimony credible that she was
unaware of the expiration of her registration at the time she issued
the prescription and did not become aware of its expiration until she
filed her application for her state pharmacy license and was required
to provide the expiration date. Notably, the Government adduced no
evidence sufficient to support the rejection of the ALJ's credibility
finding. As explained above, the Government produced no evidence
establishing the date on which she filed her pharmacy license
application. Nor did it establish when Respondent had last looked at
her DEA registration. And while there is evidence that various notices
regarding the expiration of her registration were likely sent to
Respondent, there is no evidence that the notices were mailed to her
new address, or forwarded from her registered address to either her new
registered address or her mailing address. See GX 1. Thus, the
Government has failed to prove that Respondent either had actual
knowledge of, or was willfully blind to, the fact that her registration
had expired. Rather, the evidence supports the conclusion that
Respondent was simply ignorant of the fact that her registration had
expired. Accordingly, the ALJ's conclusion that Respondent violated 21
U.S.C. 843(a)(2) is not supported by substantial evidence.
However, the Controlled Substances Act requires that ``[e]very
person who dispenses . . . any controlled substance, shall obtain from
the Attorney General a registration issued in accordance with the rules
and regulations promulgated by him.'' 21 U.S.C. 822(a)(2). Agency
regulations further provide that ``[a] prescription for a controlled
substance may be issued only by an individual practitioner who is . . .
[e]ither registered or exempted from registration. . . .'' \10\ 21 CFR
1306.03(a). Cf. id. Sec. 1301.13(a) (``No person required to be
registered shall engage in any activity for which registration is
required until the application for registration is granted. . . .'').
To establish a violation of 21 CFR 1306.03(a), the Government is
required to prove only that Respondent issued a prescription for a
controlled substance when she was not registered to do so; it is not
required to prove that Respondent knew that she lacked a valid
registration when she issued the prescription. Accordingly, I find that
Respondent violated DEA regulations when she issued the March 15, 2011
alprazolam prescription.\11\
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\10\ Respondent makes no claim that she was exempt from
registration.
\11\ While there was also evidence that Respondent self-
prescribed thirty tablets of zaleplon, see GX 6, at 1, the
Government offered no further evidence or argument regarding the
lawfulness of this prescription. I therefore do not consider it.
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[[Page 36589]]
Factor Five--Such Other Conduct Which May Threaten Public Health and
Safety
In making the public interest determination, ``this Agency also
places great weight on a registrant's candor, both during an
investigation and in any subsequent proceeding.'' Robert H. Hunt, 75 FR
49995, 50004 (2010); see also, e.g., The Lawsons, Inc., t/a The
Medicine Shoppe Pharmacy, 72 FR 74334, 74338 (2007); Rose Mary Jacinta
Lewis, 72 FR 4035, 4042 (2007) (holding that lying under oath in
proceeding to downplay responsibility supports conclusion that
physician ``cannot be entrusted with a registration''). As the Sixth
Circuit has recognized, ``[c]andor during DEA investigations properly
is considered by the DEA to be an important factor when assessing
whether a . . . registration is consistent with the public interest.''
Hoxie, 419 F.3d at 483.
The Government argues that Respondent knowingly made a false
statement to the DI when the DI asked her if she had written any
prescriptions after the expiration of her registration and Respondent
denied doing so. Gov't Br. 11. The ALJ rejected the Government's
contention, explaining that she found it ``quite plausible that
[Respondent] unintentionally made the false statement to'' the DI. R.D.
at 18. As support for her conclusion, the ALJ reasoned that ``the
Government's argument regarding [Respondent's] lack of candor is
undercut by the extensive and voluntary disclosures which [Respondent]
made to [the DI] during that April 2011 telephone conversation, namely
that she had not prepared or maintained any treatment records regarding
these prescriptions.'' Id. (emphasis added). The ALJ thus concluded
that ``[i]n light of the totality of [Respondent's] interaction with
[the DI] and her credible testimony at the hearing, . . . her
statement, while admittedly false, does not negatively outweigh her
overall candor with the Agency.'' Id.
I reject the ALJ's finding that Respondent unintentionally made the
false statement. Indeed, the ALJ's conclusion clearly rests on a
misreading of the record, which while not a model of clarity,
nonetheless establishes that Respondent made the false statement in a
phone call which occurred before the DI had run the PMP, and in fact,
during this phone call, the DI specifically discussed with Respondent
that her registration had expired and told her that she would be
running a PMP report ``to verify the information [Respondent] had
provided of not writing any prescriptions with an expired DEA number.''
Tr. 22-23. Moreover, the evidence clearly shows that what the ALJ
characterized as Respondent's ``extensive and voluntary disclosures''
(regarding her failure to create and maintain treatment records for her
daughter's prescriptions), were not made until a subsequent phone call
which occurred after the DI had run the PMP report. Thus, contrary to
the ALJ's understanding, it was only after Respondent was confronted
with the evidence of her misconduct that she made the admissions
regarding her failure to create records. And even then, she maintained
that she had forgotten that she had written the March 15 prescription.
Of further note, Respondent submitted her application three days
after she wrote the prescription and clearly knew then that her
registration had expired. Moreover, the phone call in which she denied
having written any prescriptions after the expiration of her
registration occurred in April 2011, approximately a month (more or
less) after she had written the prescription.\12\ It simply defies
credulity to suggest that Respondent did not remember having written
the prescription in the preceding month, especially given that the
prescription was written for her daughter.\13\
---------------------------------------------------------------------------
\12\ In its brief, the Government asserts that the conversation
occurred on April 14, 2011. Gov. Br. 11. Yet the record does not
establish anything more than that it occurred in April 2011. See Tr.
21 (testimony of DI: ``I had a phone conversation with [Respondent]
in April, and we discussed the licensing information, and at that
point, I also asked [her] if she had prescribed controlled
substances to anyone after the expiration date of her prior
registration.''); see also id. (Government counsel: ``And do you
know the date of this phone call or approximate date?'' DI: ``It was
in April . . . of 2011.'').
\13\ In support of her contention that Respondent did not
deliberately make the false statement, the ALJ also cited
Respondent's ``credible testimony at the hearing.'' R.D. at 18. Yet,
Respondent offered no testimony regarding the circumstances
surrounding her statement. Thus, the ALJ's finding does not rest on
a credibility determination.
---------------------------------------------------------------------------
I therefore conclude that Respondent knowingly made the false
statement to the investigator. I further conclude that the false
statement was material in that it had ```a natural tendency to
influence, or was capable of influencing, the decision of' the
decisionmaking body to which it was addressed.'' Kungys v. United
States, 485 U.S. 759, 770 (1988) (quoting Weinstock v. United States,
231 F.2d 699, 701 (D.C. Cir. 1956) (other citation omitted)) (quoted in
Samuel S. Jackson, 72 FR 23848, 23852 (2007)); see also United States
v. Wells, 519 U.S. 482, 489 (1997) (quoting Kungys, 485 U.S. at 770).
Most significantly for this proceeding, the Supreme Court has explained
that ``[i]t has never been the test of materiality that the
misrepresentation or concealment would more likely than not have
produced an erroneous decision.'' Kungys, 485 U.S. at 771 (emphasis in
original). Rather, the test is ``whether the misrepresentation or
concealment was predictably capable of affecting, i.e., had a natural
tendency to affect, the official decision.'' Id.
```[T]he ultimate finding of materiality turns on an interpretation
of substantive law,''' id. at 772 (int. quotations and other citation
omitted), and must be met ``by evidence that is clear, unequivocal, and
convincing.'' Id. That standard is met here. As explained above, under
federal law, a practitioner cannot lawfully dispense a controlled
substance unless she possesses a registration or is otherwise exempt
from registration.\14\ 21 U.S.C. 822(a)(2); 21 CFR 1306.03(a). So too,
it is a violation of federal law for a practitioner to knowingly use an
expired registration to dispense a controlled substance.\15\ 21 U.S.C.
843(a)(2). Respondent's false statement denying that she had issued any
controlled substance prescriptions after her registration expired was
clearly material under the public interest standard, because the
standard clearly directs the Agency to consider an applicant's
``[c]ompliance with applicable . . . Federal . . . laws relating to
controlled substances.'' Id. Sec. 823(f)(4).
---------------------------------------------------------------------------
\14\ Respondent makes no argument that she was exempt from
registration at the time she issued the prescription to her
daughter.
\15\ That in this matter, the Government did not ultimately
prove Respondent knew that her registration had expired does not
make her statement immaterial. Moreover, at the time of the
statement, Respondent knew her registration had expired, and that
when she issued the prescription, she did not have authority to do
so. 21 CFR 1306.03(a).
---------------------------------------------------------------------------
That the DI made clear that she intended to obtain a PMP report and
verify the validity of Respondent's statement does not make her
statement immaterial. As the First Circuit has noted with respect to
the material falsification requirement under 18 U.S.C. 1001, ``[i]t
makes no difference that a specific falsification did not exert
influence so long as it had the capacity to do so.'' United States v.
Alemany Rivera, 781 F.2d 229, 234 (1st Cir. 1985); see also United
States v. Norris, 749 F.2d 1116, 1121 (4th Cir. 1984) (``There is no
requirement that the false statement influence or effect the decision
making process of a
[[Page 36590]]
department of the United States Government.'').
To the extent the ALJ's opinion suggests that because Respondent,
in a subsequent conversation, admitted to various other acts (but not
to writing a prescription after her registration expired), and thus her
overall candor excuses her false statement, I reject it. Indeed,
adopting the ALJ's reasoning would create a perverse incentive to
falsely deny the commission of acts which could result in the denial of
one's application, in the hope that the Agency's investigator would
simply take one at her word. Contrary to the ALJ's understanding, there
is no free pass for those who make a false statement during the course
of an Agency investigation, and those who seek registration from the
Agency have an obligation to provide truthful answers to all material
questions asked by Agency personnel, no matter the stage of the
investigation. I therefore conclude that Respondent's false statement
provides additional grounds to conclude that her registration would be
inconsistent with the public interest.\16\
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\16\ Respondent's false statement has generally been considered
under factor five, as other conduct which may threaten public health
or safety.
---------------------------------------------------------------------------
Sanction
As found above, while I reject the Government's contention that
Respondent lacked a legitimate medical purpose and acted outside of the
usual course of professional practice in violation of federal and state
law when she prescribed to her daughter, I nonetheless find that
Respondent violated federal law when she issued a controlled substance
prescription after the expiration of her registration and then made a
materially false statement to the DI when she denied having issued any
such prescriptions after the expiration of her registration. Had the
proven violations been limited to Respondent's issuance of a controlled
substance prescription after the expiration of her registration, I
would likely have concluded that denial of her application would be
unwarranted. See Jacobo Dreszer, 76 FR 19386, 19387-88 (2011) (holding
that even where the Government has made out a prima facie case under
the public interest standard, a respondent can argue that ``his conduct
was not so egregious as to warrant revocation''); Gregory D. Owens, 74
FR 36751, 36757 n.22 (2009) (``in assessing what sanction to impose,
the Agency . . . considers the extent and egregiousness of a
practitioner's misconduct.'').
However, I find that Respondent's act in making a materially false
statement to the Investigator constitutes sufficiently egregious
misconduct to support the denial of her application. I therefore hold
that the Government has satisfied its prima facie burden of showing
that issuing a new registration to the applicant would be inconsistent
with the public interest.
As DEA has repeatedly held, upon this showing, the applicant must
then ``present sufficient mitigating evidence'' to show why she can be
entrusted with a new registration. Medicine Shoppe-Jonesborough, 73 FR
364, 387 (2008) (quoting Samuel S. Jackson, 72 FR 23848, 23853 (2007)
(quoting Leo R. Miller, 53 FR 21931, 21932 (1988))). ``Moreover,
because `past performance is the best predictor of future performance,'
ALRA Labs. Inc. v. DEA, 54 F.3d 450, 452 (7th Cir. 1995), [DEA] has
repeatedly held that where a registrant has committed acts inconsistent
with the public interest, the registrant must accept responsibility for
[her] actions and demonstrate that [she] will not engage in future
misconduct.'' Medicine Shoppe, 73 FR at 387; see also Jackson, 72 FR at
23853; John H. Kennedy, 71 FR 35705, 35709 (2006); Cuong Tron Tran, 63
FR 64280, 64283 (1998); Prince George Daniels, 60 FR 62884, 62887
(1995); Hoxie v. DEA, 419 F.3d at 483 (``admitting fault'' is
``properly consider[ed]'' by DEA to be an ``important factor[]'' in the
public interest determination). So too, in determining the appropriate
sanction, the Agency has a substantial interest in deterring future
acts of misconduct, both on the part of a respondent in a particular
case and the community of registrants. See Joseph Gaudio, 74 FR 10083,
10094 (2009) (quoting Southwood Pharmaceuticals, Inc., 72 FR 36487,
36504 (2007)); see also Butz v. Glover Livestock Commission Co., Inc.,
411 U.S. 182, 187-88 (1973); Michael S. Moore, 76 FR 45867, 45868
(2011).
Here, the ALJ found that ``Respondent has both taken responsibility
for her actions and shown remorse for her unlawful conduct.'' R.D. at
17 (citing Tr. 53, 59). As to the first citation, Respondent testified
regarding her having been reprimanded, for--in the words of her
counsel--``not filling out things in a timely basis.'' Tr. 53. In this
regard, Respondent testified that she was ``very much scattered'' and
that she now ``absolutely understand[s] the gravity of this.'' Id. The
issue, however, is not whether Respondent timely completed a renewal
application but why she issued a prescription when she lacked legal
authority to do so and then falsely denied doing so to the DI.\17\
Respondent simply offered no testimony acknowledging that she had
violated federal law when she issued a prescription after her
registration expired. Nor did Respondent even address the circumstances
surrounding the false statement she made to the DI. Accordingly, I
reject the ALJ's finding that Respondent has accepted responsibility
for her misconduct.
---------------------------------------------------------------------------
\17\ At Tr. 59, Respondent testified regarding what she had
learned in the class about prescribing for family members.
Respondent is not, however, required to acknowledge wrongdoing for
unproven misconduct.
---------------------------------------------------------------------------
In recommending that I grant Respondent's application, the ALJ also
cited various mitigating factors which I should consider including
Respondent's health problems (a 2004 heart attack), her son's death in
a motorcycle accident (in 2006), and her daughter's struggle with
mental illness after losing her health insurance. R.D. at 17. While the
first two events are indisputably tragic, they do not mitigate
Respondent's misconduct, which occurred years later.
As for her daughter's struggle with mental illness after losing her
insurance, because I find the allegation that Respondent acted outside
of the usual course of professional practice in issuing prescriptions
to her daughter to be unsupported by substantial evidence, I need not
decide whether this mitigates her conduct. However, it clearly does not
mitigate her misconduct in issuing the prescription after the
expiration of her registration, as the evidence shows that Respondent's
daughter had resumed treatment with her psychiatrist prior to the
issuance of the prescription.
Most significantly, it does not excuse her deliberate and material
false statement to the Investigator. Because Respondent has failed to
acknowledge her misconduct in making the statement, I conclude that her
application should be denied. However, in the event Respondent is
willing to acknowledge her misconduct in making this statement,
favorable consideration should be granted to a new application made no
earlier than six months from the date of this Order.
Order
Pursuant to the authority vested in me by 21 U.S.C. 823(f), as well
as 28 CFR 0.100(b), I order that the application of Belinda R. Mori,
N.P., for a DEA Certificate of Registration as a Mid-Level
Practitioner, be, and it hereby is, denied. This Order is effective
immediately.
[[Page 36591]]
Dated: June 9, 2013.
Michele M. Leonhart,
Administrator.
[FR Doc. 2013-14447 Filed 6-17-13; 8:45 am]
BILLING CODE 4410-09-P