Mark De La Lama, P.A.; Denial of Application, 20011-20020 [2011-8536]
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authority to dispense controlled
substances in Utah, the State in which
he holds his DEA registration.
The Controlled Substances Act
defines the ‘‘[t]he term ‘practitioner’ [to]
mean[] a physician * * * licensed,
registered, or otherwise permitted, by
the United States or the jurisdiction in
which he practice * * * to distribute,
dispense, [or] administer * * * a
controlled substance in the course of
professional practice or research.’’ 21
U.S.C. 802(21). Moreover, under 21
U.S.C. 823(f), ‘‘[t]he Attorney General
shall register practitioners * * * to
dispense * * * controlled substances
* * * if the applicant is authorized to
dispense * * * controlled substances
under the laws of the State in which he
practices.’’ DEA has therefore repeatedly
held that holding state authority is an
essential requirement for obtaining a
registration and maintaining an existing
one. See David W. Wang, 72 FR 54297,
54298 (2007); Sheran Arden Yeates, 71
FR 39130, 39131 (2006); Dominick A.
Ricci, 58 FR 51104, 51105 (1993); Bobby
Watts, 53 FR 11919, 11920 (1988); see
also 21 U.S.C. 824(a)(3) (authorizing
revocation ‘‘upon a finding that the
registrant * * * has had his State
license or registration suspended,
revoked, or denied by competent State
authority and is no longer authorized by
State law to engage in the * * *
dispensing of controlled substances’’).
As the Final Order of the Utah DOPL
makes clear, Respondent does not
possess authority under Utah law to
dispense controlled substances. Because
he does not meet this requirement, his
application will be denied. See 21
U.S.C. 823(f).
Order
Pursuant to the authority vested in me
by 21 U.S.C. 823(f), as well as 28 CFR
0.100(b) & 0.104, I order that the
application of Layfe Robert Anthony,
M.D., for a DEA Certificate of
Registration as a practitioner be, and it
hereby is, denied. This Order is effective
May 11, 2011.
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Dated: April 1, 2011.
Michele M. Leonhart,
Administrator.
[FR Doc. 2011–8535 Filed 4–8–11; 8:45 am]
BILLING CODE 4410–09–P
issuing controlled substance prescriptions ‘‘on
forms which falsely identified his address.’’ Id. at
21 & 24.
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 07–20]
Mark De La Lama, P.A.; Denial of
Application
On January 16, 2007, the Deputy
Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration, issued an Order to
Show Cause to Mark De La Lama
(Respondent), of Phoenix, Arizona. The
Show Cause Order proposed the denial
of Respondent’s application for a DEA
Certificate of Registration as a mid-level
practitioner (i.e., physician assistant) on
various grounds.
Specifically, the Show Cause Order
made four major allegations against
Respondent. First, the Order alleged that
Respondent’s former DEA registration
had expired on June 30, 2003, but that
Respondent had continued writing
prescriptions for controlled substances
after that date. ALJ Ex. 1, at 1 & 3. Next,
noting that as a condition of his initial
registration Respondent had entered
into a Memorandum of Agreement
(MOA) with the Agency, the Order
alleged that Respondent had violated
the MOA in two ways: First, by failing
to produce the log of his controlled
substance prescriptions which he was
required to maintain when DEA
Diversion Investigators (DIs) visited his
practice premises on April 13, 2005,
and; second, by failing to report two
changes of his practice location. Id. at 1,
2–3. Finally, the Order alleged that on
November 21, 2004, Respondent
submitted a new application for a
registration which he falsified by failing
to disclose his April 1992 and October
1994 felony convictions for offenses
related to controlled substances, as well
as the existence of the MOA. Id. at 3.
Respondent, through his counsel,
requested a hearing. The matter was
assigned to a DEA Administrative Law
Judge (ALJ), who conducted a hearing
on January 16, 2008, in Phoenix,
Arizona. ALJ at 2. Both parties called
witnesses to testify and introduced
documentary evidence into the record.
Following the hearing, both parties filed
briefs containing their proposed
findings of fact, conclusions of law and
argument. Id.
On April 2, 2009, the ALJ issued her
Recommended Decision. Therein, the
ALJ concluded that Respondent
‘‘knowingly issued prescriptions for
controlled substances using an expired
DEA registration number over a span of
nearly two years’’ but that the ‘‘lack of
evidence that Respondent issued
prescriptions for other than a legitimate
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purpose * * * weigh[s] in favor of a
finding that Respondent’s registration
would not be inconsistent with the
public interest.’’ Id. at 26.
The ALJ also found that Respondent’s
conviction record for two felonies under
Arizona law involving controlled
substances weighed ‘‘in favor of a
finding that Respondent’s registration
would be inconsistent with the public
interest.’’ Id. at 27. Based on his failure
to disclose these two felonies on his
November 21, 2004 application, the ALJ
further found that Respondent
materially falsified his application but
concluded that his conduct was only
negligent because an office manager had
completed the form for him. Id. at 28–
29. The ALJ credited ‘‘Respondent’s
testimony and * * * his expressions of
regret and recognition of his
wrongdoing on this specific point, and
* * * therefore conclude[d] that his
material falsification in the 2004
application [did] not warrant denying
his application.’’ Id. at 30.
Next, the ALJ found ‘‘that Respondent
failed to adhere to certain requirements
contained’’ in a Memorandum of
Agreement (MOA) which he was
required to enter into with the Agency
as a condition of obtaining a
registration. Id. More specifically,
Respondent ‘‘failed to maintain a log of
all controlled substances that he
prescribed as of the date of the April
2005 site visit’’ and he failed to notify
the Agency of his changes in the
location of his practice address. Id. 30–
31. The ALJ also found, however, that
Respondent ‘‘equally accepts
responsibility for what went wrong[ ]
and has demonstrated a commitment to
cooperate with DEA in the future.’’ Id.
at 32. Moreover, while the ALJ noted
that Respondent had been convicted (in
1985) in Thailand of possession and
attempted smuggling of marijuana, as
well as a more recent conviction for
driving under the influence, the ALJ
also noted that Respondent was then
practicing ‘‘at a clinic that serves a
primarily underserved and
underinsured population’’ and that this
is ‘‘an appropriate consideration in
determining whether [his] application
* * * should be granted.’’ Id. at 33.
Based on his multiple convictions for
controlled substances offenses and his
‘‘considerable difficulty [in] adhering to
some of the requirements of the’’ MOA,
the ALJ concluded that the Agency had
‘‘made out a prima facie case for denying
[Respondent’s] application.’’ Id. The ALJ
reasoned, however, that ‘‘[d]espite his
criminal convictions involving
controlled substances in the 1990s,
Respondent appears to have put that
period of his life behind him.’’ Id. at 34.
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In the ALJ’s view, Respondent’s ‘‘most
recent conviction involving controlled
substances occurred more than fifteen
years ago [and] [s]ince that time, he has
neither been implicated in nor been
convicted of any other crime involving
controlled substances [and] [t]he
Government presented no evidence that
the future would hold any differently.’’
Id. Based on his ‘‘expression of remorse
and his expressed willingness to comply
with restrictions on his registration,’’ the
ALJ ‘‘conclude[d] that the public interest
would best be served by granting
Respondent a restricted registration’’
subject to four conditions. Id. These
were that: (1) Respondent must comply
with all Federal, State and local laws
and regulations relating to controlled
substances; (2) Respondent may not
personally use controlled substances in
any form or for any reason without a
prescription issued by a duly licensed
physician who possesses a valid DEA
Certificate of Registration; (3)
Respondent must permit DEA personnel
to enter his practice location at any time
during normal business hours, without
prior notice, to verify compliance with
all applicable laws and regulations
relating to controlled substances, as well
as with any or all restrictions imposed
on Respondent as a condition of his
registration with the DEA; and (4)
Respondent must notify the DEA
Phoenix Division, in writing, of any
change of business address or employer.
Id. at 34–35.
Neither party filed exceptions to the
ALJ’s decision. On May 7, 2009, the ALJ
forwarded the record to me for a final
agency action.
During the initial review of the
record, it was noted that the
Government had introduced into
evidence—over Respondent’s
objection—a printout of a data
compilation prepared by SearchPoint, a
private entity, which purportedly listed
the prescriptions Respondent issued
between October 8, 2003 and May 23,
2005. The Government introduced this
document, which is not a record
required to be maintained under either
federal or state law, to prove the
allegations that Respondent had issued
controlled substance prescriptions even
after he knew his registration had
expired and had done so even after
being told to stop by DEA Investigators.
Because Respondent’s objection went to
the foundation for admitting the
compilation and the reliability of the
information it contains, and the
Government did not establish that the
methods used to compile the data were
sufficiently trustworthy, I remanded the
case to the ALJ for further proceedings
and specifically instructed the
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Government to address various
questions as set forth in the remand
order.1 Following additional
proceedings, the ALJ forwarded the
record back to me for final agency
action.
Having considered the entire record, I
hereby issue this Decision and Final
Order. I agree with the ALJ’s
conclusions that: (1) Respondent
materially falsified his application, (2)
that he has a significant history of
convictions relating to controlled
substances; (3) that he failed to meet the
MOA’s requirements with respect to
both his proper keeping of a log and his
obligation to notify the Agency of any
changes in his practice location.2 As the
ALJ recognized, these findings establish
a prima facie case for the denial of his
application.
However, I reject the ALJ’s conclusion
that Respondent’s employment at a
clinic that serves an underserved
population is ‘‘an appropriate
consideration in determining whether
[his] application * * * should be
granted.’’ ALJ at 33; see also Gregory D.
Owens, 74 FR 36751, 36756–57 (2009)
(rejecting consideration of
socioeconomic status of practitioner’s
patients as appropriate consideration
under the CSA). Moreover, while I do
not reject the ALJ’s findings that
Respondent has accepted responsibility
for his misconduct, I reject her proposed
sanction because it clearly rests on a
fundamental misunderstanding as to the
scope of permissible sanctions under
the CSA. Given the circumstances of
this matter, I conclude that
Respondent’s application should be
denied at this time.
The Reliability of the SearchPoint Data
Compilation
Before proceeding to make factual
findings, it is necessary to resolve the
issue of whether the ALJ properly
admitted—over Respondent’s objection
that the Government had not laid a
proper foundation—Government Exhibit
8, which it represents to be a data
compilation listing the prescriptions
Respondent issued between October 8,
2003 and May 23, 2005.3 The
1 To make clear, I remanded the case because
there was no prior Agency decision addressing the
admissibility of data compilations prepared by
private entities.
2 Under the express terms of the MOA,
Respondent agreed to surrender his registration
without issuance of an Order to Show Cause in the
event that he failed to comply with the MOA. GX
3, at 3. Also, a violation of the MOA’s terms would
‘‘result in the initiation of proceedings to revoke’’
Respondent’s registration. Id.
3 The ALJ overruled the objection after
determining that the Exhibit had been provided to
Respondent in advance of the hearing even though
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Government argues that this exhibit
showed that Respondent had issued
controlled substance prescriptions not
only following the expiration of his
registration, but also after he knew it
had expired and even after he was told
by DEA Investigators to stop doing so.4
Gov. Proposed Findings at 7–8, 10–11.
The ALJ relied on this evidence, in part,
in her decision.
Under the Administrative Procedure
Act (APA), an Order must be ‘‘supported
by and in accordance with the reliable,
probative and substantial evidence.’’ 5
U.S.C. 556(d). While the Agency’s
decision may be based on hearsay
evidence, see Richardson v. Perales, 402
U.S. 389, 410 (1971), such evidence
must still be reliable.
The compilation is not, however, a
record maintained by a government
agency. Nor is it a record which is
required to be maintained under either
federal or state law. Moreover, on
reviewing the compilation, there
appeared to be various discrepancies
which called into question the data’s
reliability. As I noted in the remand
order, this Office is unaware of any
judicial decisions either admitting or
excluding similar data compilations
prepared by SearchPoint.
At the hearing, a DI testified that
prescription information is entered by a
pharmacy into a computer which is then
collected and sent to SearchPoint. Tr.
43. The DI did not, however, explain the
basis of his knowledge. Moreover, the
record did not establish the procedures
or methods used by the pharmacies in
entering the information, when the
information is entered, whether either
the pharmacies or SearchPoint have any
procedures to verify the accuracy of the
information, whether the data is
properly secured, and whether there are
procedures to protect the data from
manipulation. Cf. McCormick on
Evidence § 314, at 886 (3d ed. 1984).
Respondent’s counsel had objected on grounds of
lack of foundation and that ‘‘we have no way of
determining the accuracy of the information as set
forth herein.’’ Tr. 66. While under the Agency’s
regulation, ‘‘[t]he authenticity of all documents
submitted in advance [is] deemed admitted unless
written objection thereto is filed with the presiding
officer,’’ 21 CFR 1316.59(c), there is no such rule
applicable to objections based on a lack of
foundation. The ALJ apparently confused these two
independent grounds for objecting to the admission
of evidence.
4 Notably, the Government did not introduce into
evidence either copies of any prescriptions
Respondent wrote during this period, or pharmacy
dispensing logs, even though such evidence should
have been readily obtainable (as a pharmacy is
required to keep such records for two years, see 21
CFR1304.04(a) and 1304.22(c)), and is what the
Government customarily uses in these proceedings
to establish that a practitioner wrote unlawful
prescriptions.
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The record also did not establish
whether a prescription that was signed
by both Respondent and a supervising
physician (which was one of
Respondent’s defenses to the allegation
that he continued to prescribe even after
he realized his registration had expired)
would be attributed to Respondent or
the physician. Nor did the record
establish why, where refills were
authorized by a single prescription, the
printout provided the same date for the
date the prescription was written and
the date it was dispensed.
Because the record did not adequately
establish the procedures or methods
used to compile this database and that
the compilation is sufficiently
trustworthy so as to satisfy the APA’s
requirement that the evidence be
reliable, I remanded the case to the ALJ
with instructions to address these
various concerns. I also expressly
ordered that the questions ‘‘must be
addressed by a witness who has
personal knowledge of the procedures
and methods used by Searchpoint.’’
Remand Order at 3.
On remand, the Government
submitted an affidavit of the same
Diversion Investigator whose testimony
I previously found to be inadequate for
establishing that the SearchPoint data is
reliable. From his affidavit, it is clear
that the DI lacks personal knowledge of
the procedures and methods used by
SearchPoint. See Affidavit of Miguel
Rodriguez.
This, by itself, is reason to conclude
that the Government has failed to
comply with the remand order.
However, even in his affidavit, the DI
offered no evidence which establishes
that the SearchPoint data is reliable. To
the contrary, the DI explained that:
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[t]he accuracy and authenticity of the data
was only as good as the accuracy of the
pharmacy reporting. It was stipulated to all
DEA investigators, that SearchPoint was only
a pointing tool and the data provided by
SearchPoint was to be verified against actual
records that the pharmacy, distributor, [or]
practitioner was required to maintain by
current regulations and laws.’’
Id. at 4 (emphasis added).
The DI further acknowledged that he
‘‘did not verify the information found
during the query of the SearchPoint
database prior to meeting with
[Respondent] on April 13, 2005.’’ Id. at
4–5. (Indeed, it is apparent that the DIs
did not verify the information even after
meeting with Respondent as there are
no ‘‘actual records’’ in evidence.) The
DI’s statement that the SearchPoint data
was only to be used as a ‘‘pointing tool’’
begs the question of why the actual
pharmacy (or Respondent’s patient)
records were never obtained.
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Based on the DI’s assertion that the
SearchPoint database was ‘‘a valuable
tool in DEA’s investigative efforts,’’ id. at
5, ‘‘the Government respectfully
request[ed] an additional finding that
the SearchPoint data proved useful in
DEA’s investigation of Respondent, and
helped further the objectives of DEA’s
investigation.’’ Gov’t Memorandum on
Remand at 2. Contrary to the
Government’s understanding, whether
the SearchPoint data proved useful in
its investigation is not material to the
resolution of any issue in this
proceeding.
As the Government’s brief makes
clear, determining the extent of
Respondent’s issuance of prescriptions
after his registration expired and
assessing his culpability in doing so is
one of the central issues in this matter.
Given that there was no clear agency
precedent addressing the admissibility
of similar data compilations, this
proceeding was remanded to determine
whether the SearchPoint data was
sufficiently reliable to prove that
Respondent had continued to issue
controlled substance prescriptions not
only after he became aware that his
registration had expired, but also after
he was told by a DI to stop doing so.
Notwithstanding that the remand
order clearly stated what the
Government was required to show to
establish that this evidence is reliable, it
failed to do so. Because the Government
failed to comply with the remand order
and offers no valid excuse for its failure
to do so, I conclude that the SearchPoint
compilation is not competent evidence
and should have been excluded. See 21
CFR 1316.59(a) (‘‘The presiding officer
shall admit only evidence that is
competent, relevant, material and not
unduly repetitious.’’). Accordingly, as
ultimate factfinder, I do not base any of
my findings on it.
Findings
Respondent is a physician assistant,
who is licensed by the Arizona
Regulatory Board of Physicians
Assistants (The Board). GXs 6 & 7. At
the time of the hearing, Respondent was
49 years of age. Tr. 286.
Respondent obtained a Bachelor of
Science degree in human biology in
1997 and a Master’s degree in physician
assistant studies in October 1999. Id. at
208. After obtaining his state license,
Respondent commenced working as a
physician assistant; his duties involve
performing physical exams, making
diagnoses, treating patients, interpreting
test results, and ordering diagnostic
tests and studies. Id.
On October 26, 2000, Respondent
applied for a DEA registration to handle
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controlled substances in Schedules II
through V as a mid-level practitioner.
GX 2. On the application, Respondent
was required to answer four ‘‘liability
questions’’; the questions included
whether the applicant had ever been
convicted of an offense related to
controlled substances under either
federal or state law. Id. at 2.
Respondent answered in the
affirmative and provided an explanation
of the circumstances surrounding a 1992
marijuana conviction. Id. Respondent
wrote that in 1989 or 1990, a friend he
met in karate class was involved in
‘‘selling dope’’ and that Respondent
‘‘made the horrible mistake of trying to
make a ‘fast buck.’ ’’ Id. Respondent also
stated on the application that ‘‘I entered
guilty pleas in 1992 and have never
violated any of the terms of my
probation.’’ Id.
Respondent also stated on the
application that his ‘‘criminal
convictions were expunged by the
Maricopa County Superior Court in
1999,’’ based on the recommendation of
his probation officer. Id. He also
‘‘regret[ted] this experience in [his] life’’
and that his ‘‘goal was to be the best P.A.
and father I can be.’’ Id.
On February 12, 2001, the Agency
granted Respondent’s application. GX 1.
However, because of his prior
conviction, the Agency issued him a
restricted registration; as a condition of
his registration, Respondent was
required to enter into a Memorandum of
Agreement (MOA), which imposed
various conditions on his registration.
Tr. 19; GX 3.
The MOA further detailed
Respondent’s drug-related offenses,
which included two other drug
convictions, one of which should
clearly have been disclosed on his
application, but was not. On May 3,
1985, Respondent was convicted in
Bangkok, Thailand for ‘‘Possession and
Attempted Smuggling’’ of approximately
145 grams of marijuana. GX 3, at 1. The
court suspended the 21-month sentence,
and Respondent paid a fine and
completed two years of probation. Id.
On or about April 10, 1992,
Respondent entered into a plea
agreement in which he pled guilty to
‘‘Attempted[] Possession, Use,
Production, Sale and Transportation’’ of
approximately eight pounds of
marijuana, a class 3 felony under
Arizona law. Id. Respondent paid a fine,
was jailed for two months, and was
placed on five years’ probation.5 Id.
5 On June 16, 1999, the Maricopa County Superior
Court vacated the judgment of guilt and restored
Respondent’s civil rights. Id. at 2. This is the felony
that he listed on his application in 2000.
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With respect to this incident,
Respondent maintained at the hearing
that he ‘‘was approached by somebody’’
and ended up being ‘‘a fall guy.’’ Tr. 284.
On October 24, 1994, Respondent was
found guilty of ‘‘Conspiracy to Transfer,
Sell or Possess’’ a narcotic drug, a class
2 felony under Arizona law, based on
his involvement in a conspiracy to
illegally import cocaine from Panama to
the United States. GX 3, at 2.
Respondent was fined and sentenced to
seven years’ probation, but the
probation was subsequently
reduced.6 Id. With respect to this
conviction, Respondent maintained at
the hearing that he was not ‘‘directly
involved’’ in the conspiracy because he
only ‘‘had phone conversations with the
particular individual,’’ but he
nevertheless pled guilty. Id. at 288–90.
Respondent did not disclose this
conviction on his initial application. GX
2, at 2; Tr. 293. When questioned as to
why, Respondent stated that he
‘‘suppose[d]’’ that it was because of
‘‘inadvertence’’ on his part and added
that ‘‘[i]t was all at the same time,’’
apparently referring to the marijuana
distribution offense. Tr. 293.
As found above, as a condition of his
registration, Respondent entered into an
MOA, under which he agreed to comply
with various conditions. The MOA was
to remain in effect for five years from
the date of signing, January 25, 2001,
during which time the DEA would be
able to monitor Respondent’s handling
of controlled substances. Tr. 115–16; GX
3, at 2.
As relevant to the allegations in this
proceeding, Respondent agreed ‘‘to
maintain a log for five years, which will
list all controlled substances that he
prescribes.’’ GX 3, at 2. The log was
‘‘subject to inspection by DEA for five
years from the date’’ the MOA was ‘‘fully
executed,’’ which was January 30, 2001.
Id. at 2–3.
Second, Respondent agreed ‘‘that DEA
personnel may enter his place of
practice at any time during regular
business hours, without prior notice, to
verify compliance’’ with the MOA. Id. at
3. Finally, Respondent agreed ‘‘to notify
the DEA Phoenix Division prior to
transferring his DEA Certificate of
Registration to another address within
the state of Arizona or to another state.’’
Id. In the MOA, Respondent indicated
that he would be registered at the
location of 3201 West Peoria Avenue,
Suite A–202, Phoenix, Arizona. Id. at 1.
In October 2000, Respondent began
working as a physician assistant under
6 The Superior Court also apparently vacated this
conviction in 1999, when it restored Respondent’s
civil rights. Tr. 210.
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the supervision of a Dr. John Curtin, at
the above address. Tr. 223. Sometime
thereafter, Respondent contracted
pneumonia and missed substantial time
from work; upon his return, his hours
were reduced. Id. at 224. Consequently,
in 2001 or 2002, Respondent left this
position and went to work for William
Zachow, D.O., who owned 21st Century
Family Medicine (21st Century), 6707
North 19th Ave., Suite 201, Phoenix,
Arizona. Id. at 167–68, 224. Respondent
did not notify DEA of this change of
practice address, as required by the
MOA.7 Tr. 38–39.
As part of Respondent’s employment
agreement at 21st Century, the clinic
was to handle matters related to his
licensing fees, his malpractice coverage
and his DEA registration. Id. at 224.
Specifically, Sonia Zachow, Dr.
Zachow’s wife, ‘‘would take care of the
fees and all the licensing and the DEA.’’
Id. at 224–25. Respondent testified that
this was a verbal agreement, as it had
originally been with his first employer,
Dr. John Curtin, and that he trusted Dr.
Zachow to honor the agreement. Id. at
219. Respondent testified that ‘‘[f]rom
my understanding, all my mail went to
[Sonia Zachow] and through her. I
didn’t receive any.’’ Id. at 225. In
particular, Respondent testified that he
never received a notification from DEA
that his registration would expire after
June 30, 2003. Id. Given that he had not
notified the Agency of his new address,
this is hardly surprising.
Shirley Reigle, a medical assistant at
21st Century, testified that she was
employed at the clinic when
Respondent was hired and that she
worked with Respondent for four or five
years. Id. at 168, 193. Ms. Reigle
testified that she managed the ‘‘back
office,’’ coordinating the activities of the
medical assistants, while Sonia Zachow
managed the ‘‘front office,’’ or business
office. Id. at 169–71. Mrs. Zachow’s
responsibilities included the renewal of
the licenses and DEA registrations held
by the clinic’s physicians and physician
7 Respondent also testified that the year 2001 was
a difficult year: In May his father fell from a roof
and was hospitalized for 21 days with a brain
hemorrhage before he finally died; Respondent took
in three more dependents into his household as a
result of his father’s death; later that year,
Respondent developed pneumonia, and when he
returned to work his employer noticed he was
depressed and referred him to counseling; then the
national crisis of September 11, 2001 happened. Tr.
220–221. Respondent testified that ‘‘there was a lot
of stuff that happened in 2001 that I think I was
a little bit confused, just overwhelm[ed].’’ Id. at 221.
While this sequence of events may have
overwhelmed Respondent, and provide some basis
for excusing his failure to notify the Agency of his
having changed his location, it is not a credible
explanation for his failure to renew his registration,
which did not expire until June 30, 2003.
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assistants, the renewal of insurance
coverage and the billing of insurance
claims. Id. at 171, 174, 176. According
to Ms. Reigle, Mrs. Zachow’s
responsibilities further included
notifying the DEA if a physician or
physician assistant moved his or her
location of practice. Id. at 188. However,
in one instance prior to Respondent’s
employment at 21st Century, Ms. Reigle
tried to induce Mrs. Zachow to give
notice of a move but ended up having
to provide the information to DEA
herself. Id. at 204–05.
Respondent’s DEA registration
expired June 30, 2003. Id. at 42; GX 1.
According to Ms. Reigle, sometime in
late 2003, Mrs. Zachow entered the
office that Ms. Reigle shared with
Respondent and threw a bill from the
DEA onto Respondent’s desk, saying,
‘‘Why should I pay his DEA license
when we’re selling the practice.’’ Tr.
176–77, 181. Ms. Reigle testified that
she believed that Respondent ‘‘had gone
for the day’’ and that, when she told
Respondent about the incident later and
he went to his desk to look, the bill was
no longer on his desk. Id. at 177, 199.
While Ms. Reigle testified that she told
Respondent about the incident, he
apparently took no action to determine
whether he still held a valid
registration.
Respondent testified that he did not
receive notice that his registration
required renewal and that, had he
known, he would not have continued to
practice without it. Id. at 225.
Respondent admitted, however, that at
the time he received his registration he
knew it was subject to renewal in three
years. Id. at 301. He further asserted that
he did not keep track of the time or
display his registration certificate and
that he expected the office manager to
handle matters pertaining to his
licenses, as that was done for all
incoming health care providers. Id.
Respondent did, however, acknowledge
that he was ultimately responsible for
renewing his registration. Id. at 220.
Respondent left 21st Century
sometime between July and October
2004, when Dr. Zachow sold the
clinic.8 Id. at 217. Respondent began
practicing at the 51st Avenue Clinic
(51st Avenue), which is located at 4700
North 51st Street, Suite 6, in Phoenix.
Id.; GX 4, at 1.9
When the clinic did not offer him
adequate hours, Respondent resumed
8 As was much of his testimony regarding the
dates of various events, Respondent’s testimony as
to the date when he left 21st Century and
commenced working at the 51st Avenue clinic was
vague.
9 Respondent used the address of this clinic on
his 2004 application. GX 4.
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working on a part-time base at 21st
Century and split his time between the
two clinics. Tr. 217–18. Sometime in
October 2004, Respondent received a
letter from the Arizona Physician’s
Assistants Board notifying him that his
‘‘license had lapsed [on] October 1,
2004.’’ GX 9, at 4.
Respondent testified that during the
period in which he moved to the new
practice, pharmacies were not honoring
the prescriptions he wrote at his new
employer, and that his ‘‘office was
getting calls for the prescriptions that
[he] had been writing, and they were
talking about a DEA number.’’ Tr. 226–
27. Notwithstanding the phone calls,
Respondent maintained that he did not
know that the registration had ‘‘lapsed’’
until three or four months later when,
in November 2004 or early 2005, he was
‘‘contacted by DEA.’’ Id. at 226–27. In
November 2004, Ms. Muniz, the office
manager at 51st Avenue, told
Respondent that he needed to reapply
for a DEA registration.10 Id. at 228.
According to Respondent, Ms. Muniz
filled out the application for him and
showed him only the signature page,
which he signed without reviewing. Id.
at 228–29, 262–63, 309–10. As with his
previous application, the form asked
Respondent whether he had ‘‘ever been
convicted of a crime in connection with
controlled substances under state or
federal law?’’ GX 4, at 1; ALJ Ex. 3, at
3. The ‘‘no’’ answer was circled on the
application. GX 4, at 1. Moreover,
Respondent left blank the box which the
form provided for explaining a ‘‘yes’’
answer to this question, and which is on
the same page as the signature block. Id.
at 2. The application was then
submitted.
As to why he did not disclose his
convictions, Respondent testified: ‘‘I was
busy. I was probably seeing 50 patients
a day. I was trying to make an
impression.’’ Tr. 228. According to
Respondent, had Ms. Muniz given him
the entire application, he would have
given a detailed explanation and an
answer of ‘‘yes’’ to the liability question,
just as he had done on his October 2000
application. Id. at 229.
10 In a letter he faxed to a DI on April 24, 2005,
Respondent indicated that in October of 2004, he
‘‘received a letter stating that my P.A. license had
expired’’ and that after ‘‘doing some investigation,
it turn[ed] out [that] my fees had not been paid.’’
GX 9, at 1. Sometime around the time that he got
his state license reinstated, he ‘‘got a call from the
former office manager stating that I had better check
up on my malpractice fees. It turn[ed] out those had
not been paid in over a year.’’ Id. Moreover, in the
same October time period, his new clinic ‘‘was
getting calls back from the pharmacy saying that my
DEA license was no longer valid’’ but that he did
not think too much about it at first as ‘‘I didn’t know
that the license could expire.’’ Id. at 2.
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The ALJ specifically credited
Respondent’s testimony that he would
not have provided a ‘‘no’’ answer ‘‘had
he personally filled out the form’’ and
that ‘‘he would have detailed the
explanation of his past conduct as he
had done in 2000.’’ ALJ at 29. The ALJ
further credited Respondent’s
‘‘expressions of regret and recognition of
his wrongdoing’’ in submitting the
application. Id. at 30. The Government
did not except to these findings.
It is undisputed that after filing his
application, Respondent continued to
write prescriptions for controlled
substances under his expired
registration even though he then clearly
knew that it had expired and did so
through at least March 2005. See GX 9,
at 4; see also Resp. Prop. Findings at 6–
7. Respondent offered two main (and
somewhat inconsistent) explanations for
why he continued to write prescriptions
during this period.
First, in a written statement he
provided to an Agency investigator in
April 2005, Respondent claimed that
‘‘after reapplying’’ there was ‘‘some
confusion * * * as to what was going
on at that time, some months went by
and [he] was informed by the clinic’s
office manager that she had taken care
of everything and it was okay to write
again.’’ GX 9, at 4. Continuing,
Respondent explained that Ms. Muniz
had contacted someone ‘‘at DEA
headquarters and he had informed her
that we had filled out the incorrect
application and our money had been
posted to the wrong account, he said he
would fax over the correct application
to be filled out immediately and faxed
back.’’ Id. Respondent maintained that
employees had said that ‘‘the money
would be posted to the correct account
and this would make the license active
at this point.’’ Id. Respondent faxed in
the new application on February 17,
2005. Id.
Respondent further asserted that he
‘‘wrote very few prescriptions during
this time [when he] was waiting for a
copy of the new license.’’ Id. According
to Respondent, ‘‘[a]fter several weeks of
not receiving [the] paperwork[,] we
called again and were informed that
there was a problem.’’ Id. Respondent
added that ‘‘[a]t this time I discontinued
completely and left the controlled
substances, the few we do write up to
the responsibility of my supervising
physicians.’’ Id. at 5. Finally,
Respondent claimed that while he could
not ‘‘recall the very last prescription I
wrote, it probably was over a month or
two ago and was some cough syrup with
codeine as I wrote very little in the first
place.’’ Id.
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Second, in his testimony, Respondent
further claimed that he ‘‘was getting cosignatures on the prescriptions if I did
need to write or just having them
written altogether by a supervising
physician.’’ Tr. 230. Respondent
explained that the co-signed
prescriptions would be ‘‘[o]ne
prescription, my name and the doctor’s
name, usually above mine.’’ Id. at 231.
Respondent also asserted that the
pharmacy ‘‘might have run it [the
prescription] as my DEA, but actually
the doctor, the supervising physician, it
was under his DEA as well if his
signature’’ was on the prescription. Id.
Respondent further asserted that he had
‘‘some copies’’ available that would
show that his prescriptions were being
co-signed. Id.
Respondent submitted a letter (which
is unsworn) dated April 22, 2005
written by Ms. Muniz, Director of
Operations for the 51st Ave. Family
Clinic. RX 8. According to the letter,
Respondent submitted a renewal
application sometime around December
3, 2004, when the payment for the
application fee cleared. Id. However,
after several months, Respondent had
still not gotten his registration. Id.
According to Ms. Muniz, she then called
DEA Headquarters and was told that
Respondent had submitted the wrong
form. Id. The employee at DEA
Headquarters then faxed over the correct
form which Respondent then submitted.
Id. According to Ms. Muniz, the
employee told her that he would post
the previous payment to the correct
account and this would activate
Respondent’s registration. Id. However,
according to an affidavit of a DEA
Diversion Investigator, ‘‘there is no
record of’’ Respondent’s having
submitted an application after
November 21, 2004. Affidavit of Miguel
Rodriguez, at 6.
Based on Respondent’s ‘‘no’’ answer
on his 2004 application to the liability
question regarding whether he had any
prior convictions for controlled
substances offenses, a DI commenced an
investigation. Tr. 93. The DI reviewed
the records from the Agency’s prior
investigation, police reports and the
MOA. Id. at 93–95. He also learned that,
in September 2003, Respondent had
been arrested in Florida for a hit-andrun incident while driving under the
influence.11 Id. at 103.
11 There was no evidence presented that
Respondent was under the influence of a controlled
substance at the time of the incident. Tr. 256.
Moreover, there is no evidence in this record that
Respondent has recently abused controlled
substances. I therefore conclude that the incident
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Using Respondent’s registration
number, the DI also conducted a search
of Respondent’s controlled substance
prescriptions using the SearchPoint
database. Id. at 42–44, 76. The data
indicated that Respondent had written
controlled substance prescriptions after
the expiration of his registration (June
30, 2003). Id. at 42–43. However, the DI
testified that after reviewing the data, he
did not have any concerns about
Respondent’s prescribing other than that
he lacked a registration. Tr. 152.
On April 13, 2005, as part of his
investigation of Respondent’s
application, the DI and his senior
partner visited Respondent at the 51st
Avenue clinic, which was the address
Respondent had given on his
application. Tr. 30–31. However, this
address was different from Respondent’s
address of record on file with the
Agency, as Respondent had not notified
the Agency that he had changed his
practice location and had therefore
violated the MOA. Id. at 31.
According to the DI, Respondent was
not authorized to handle controlled
substances at the 51st Avenue clinic. Id.
at 33. The DI testified that, although
failing to notify DEA of a change of
address is not typically the sole basis for
revoking a DEA registration,
Respondent’s failure to comply with the
address-change provision of the MOA
gave cause for particular concern. Id. at
109. However, the Government
produced no evidence that Respondent
had done anything other than write
prescriptions at this address.
During the visit, the DI did not
observe Respondent working under the
supervision of a physician, and
Respondent did not inform him or his
partner that he was working under
physician supervision. Id. at 31–32. The
DIs then asked to inspect the log which
Respondent was required to maintain
under the MOA. Id. at 33. Respondent
left the room and returned with a box
containing an assortment of papers and
several folders in no particular order. Id.
at 33–34. Respondent partially
attributed the disorganization of his
‘‘log’’ to the fact that he was in the
process of moving into a new practice
while continuing to work part-time at
the other such that each location had its
own records. Id. at 327. Yet, at this
point, he had been at 51st Avenue clinic
for at least six months.
According to the DI, his partner
examined the contents of the box and
asked whether Respondent had records
more recent than those for the year
2003. Id. at 35–36, 124–25, 160–61.
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Respondent answered that he could ‘‘put
something together,’’ thus indicating
that he was not currently keeping a log.
Id. at 36, 125. However, the DIs did not
take the box to copy the contents and
‘‘never asked for a copy.’’ Id. at 249, 251.
Respondent later testified that ‘‘I had it
together and I’d have produced—I even
took a ledger and * * * copied them all
down so I did have a log book of the
individual entries.’’ 12 Id. at 251.
In a subsequent conversation,
Respondent offered the material to the
DI to which the latter responded: ‘‘ ‘No,
I’ll give [the letters] you have already
provided to me to Washington and it
will go from there.’ ’’ Id. The DI admitted
that he and his partner did not ask for
copies of the materials in the box and
did not offer Respondent the option to
submit later the materials that he would
gather together. Id. at 128.
Respondent testified that he had
photocopied his notes of ‘‘patient
encounters,’’ which contained ‘‘the
patient’s name, date of birth, everything
that we’re seeing about that patient on
that day and the reasonable explanation
of why you would write a controlled
substance for that patient on that day’’
as well as the controlled substance
prescriptions he had written and then
placed the copies in a manila folder in
a box. Id. at 216, 235, 239. Respondent
testified that he thought this would be
‘‘even better than a logbook.’’ Id. at 216,
235. As he explained:
Now I thought that if there was ever a
question about my writing abilities and what
I was doing, that I could pull up the patient
encounter and show my reasonable action on
why I would write a prescription on that
particular day for that particular patient. So
I thought it was actually better than a
logbook.
Id. at 236.13
The parties disputed whether what
Respondent had presented to the DIs
constituted a log. According to the DI,
a log is ‘‘something that we could easily
obtain and review to check and verify
[Respondent’s] prescription habits,’’
which would normally be a ‘‘bound
book with notations’’ or a ‘‘binder with
prescriptions.’’ Tr. 34–35. The DI
testified that he did not consider the
records in the box to be ‘‘easily
reviewable.’’ Id. at 36. However, he later
12 Copies of this document were apparently
offered as Respondent’s Exhibit 2. However, the
Government objected to the admission of the
exhibit on the ground that it was not timely
exchanged, and the ALJ sustained the objection.
13 At the hearing, Respondent attempted to enter
copies of this ‘‘log’’ into evidence as Respondent’s
Exhibit 1, but the Government objected on the
ground that the documents had not been timely
provided to the Government. Id. at 242–43, 248.
The ALJ’s sustained the objection and rejected the
evidence. Id. at 248.
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conceded that the MOA did not specify
what format the log was to be
maintained in and that the information
he sought could be obtained from the
copies of the prescriptions. Id. at 36,
122.
Respondent testified that he
‘‘[p]robably’’ did not ‘‘completely’’
understand the MOA’s requirement. Id.
at 215. However, he also testified that
‘‘[a] log is actually a journal reading; it’s
a journal.’’ Id. at 321. Respondent then
testified that he thought ‘‘that a patient
list was even better [and] was the same
thing as a log book.’’ Id. He also
maintained that ‘‘there was nothing in
the [MOA] that told me how * * * a
patient log book should look,’’ but then
acknowledged that he never inquired of
the Agency what the log should consist
of ‘‘[b]ecause [he] thought that from
what [he] had seen with other
physicians, what they used was a photoa three- or double—you know, the twosided prescriptions where you just get a
copy of it, that’s what I’d seen.’’ Id. at
322.
Respondent further testified that,
while initially he kept the copies of
prescriptions and patient encounters in
a box in the office in chronological
order, when he moved from 21st
Century to 51st Avenue in October
2004, he placed the records from the
new location in another box. Id. at 217,
237. Thus, at the meeting on April 13,
2005, he was only able to produce a
portion of the prescriptions he had
written as the remaining records were at
21st Century. Id. at 235–38.
The DIs discussed with Respondent
the MOA’s requirement that he notify
the DEA before transferring his
registration to another address. Id. at 37;
GX 3, at 3. Respondent told them that
he was not sure whether he had notified
the Agency of his most recent move, and
he acknowledged that he had moved to
51st Avenue approximately six months
earlier. Tr. 38–39. He also told the DIs
that he had worked at 21st Century for
four years prior to the move to 51st
Avenue and that this address was also
different from the address at which he
had originally been registered. Id. at 38–
39, 154; RXs 6 & 8. Respondent
provided the DIs with two changes of
address: 4700 North 51st Avenue, Suite
6, Phoenix, Arizona, and 1526 West
Glendale Avenue, Suite 109, Phoenix,
Arizona. Tr. 38–39. Although he
testified that it was ultimately his
responsibility to advise the DEA that he
had changed his practice address,
Respondent maintained that it had been
the responsibility of Mrs. Zachow to do
so. Id. at 188 & 190.
The DIs also discussed with
Respondent the fact that his DEA
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registration had expired. Tr. 59.
Respondent told them that he had
learned that the registration had expired
several months before their meeting. Id.
at 59, 113–14. Respondent further told
the investigators that the office manager
(Sonia Zachow) had been responsible
for renewing the registration and had
failed to do so. Id. at 112, 114–15.
During the April 13, 2005 meeting,
the DI’s senior partner instructed
Respondent to desist from writing
prescriptions for controlled substances;
Respondent agreed that he would not
write prescriptions for controlled
substances. Id. at 62–63, 78.
At the hearing, Respondent testified
that he had complied with the DI’s
instruction. Id. at 345. More specifically,
Respondent testified that ‘‘I’ve been
compliant from the day when I said—
when they told me you can’t write
controlled substances I’ve been—not
written one.’’ Id.
A DI testified that sometime after May
23, 2005, he conducted a second search
of Respondent’s DEA registration
number on SearchPoint and found that
Respondent had written controlled
substance prescriptions after the April
13, 2005, meeting. Tr. 77. However, for
reasons explained above, because the
Government did not comply with the
instructions in the remand order for
establishing that the SearchPoint data is
reliable, I conclude that the Government
has not proved that Respondent violated
the DI’s order to stop writing
prescriptions. I further find that the
Government has failed to produce any
reliable evidence rebutting
Respondent’s contention that he had his
prescriptions co-signed by a supervising
physician after he became aware that his
registration had expired.14
At the hearing, Respondent testified
that he was compliant with the MOA;
that his work as a physicians assistant
was difficult and stressful; that he had
no training in office administration; and
that he had learned how to be a ‘‘better
professional’’ from this experience with
his DEA registration expiring. Tr. 257–
59.
Respondent testified that, although he
currently works as a physicians
assistant without writing controlled
substance prescriptions, his lack of
authority to do so significantly
diminishes his employer clinic’s ability
to treat patients: he is the only health
care provider at the current clinic and
cannot prescribe drugs necessary to treat
such common ailments as excessive
weight, Attention Deficit Disorder/
Attention Deficit-Hyperactivity
14 The Government does not address whether this
practice is even permissible under Arizona law.
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Disorder, acute pain, acute anxiety
attacks, and testosterone deficiencies.
Id. at 267 & 278. If he cannot substitute
a non-controlled substance, he must
refer a patient who requires a controlled
substance to a physician or another
facility. Id. at 273.
According to Respondent, in around
July 2005, his boss at the 51st Avenue
clinic gave him two weeks to resolve the
issues surrounding his DEA registration
and told him he would lose his job if he
did not do so because insurance
companies use the DEA registration
number as a tracking number for
reimbursement. Id. at 259–60.
Respondent subsequently lost his job at
this clinic but subsequently gained
employment at his current clinic. Id. at
260.
Respondent further testified that he
had ‘‘made a lot of mistakes’’ and that he
did not ‘‘plan on this happening again.’’
Id. at 267. Respondent added that he
could not ‘‘afford to make any mistakes
in [his] life anymore,’’ that he had ‘‘made
plenty’’ and was ‘‘sorry’’ to have ‘‘made
them’’ and was ‘‘remorseful.’’ Id. at 268.
He further stated that while ‘‘I made
countless errors here * * * I’ve learned
from them and I don’t think I’ll ever see
a courtroom again.’’ Id.
Discussion
Section 303(f) of the Controlled
Substances Act (CSA) provides that an
application for a practitioner’s
registration may be denied upon a
determination ‘‘that the issuance of such
registration would be inconsistent with
the public interest.’’ 21 U.S.C. 823(f). In
making the public interest
determination, the CSA requires 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.
These factors may be considered in
the disjunctive, and I ‘‘may rely on any
one or a combination of factors and may
give each factor the weight [I] deem[]
appropriate’’ in determining whether an
application for registration should be
denied. Robert A. Leslie, 68 FR 15227,
15230 (2003). Moreover, I am ‘‘not
required to make findings as to all the
factors.’’ Hoxie v. DEA, 419 F.3d 477,
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482 (6th Cir. 2005); see also Morall v.
DEA, 412 F.3d 165, 173–74 (DC Cir.
2005).
Under DEA precedent, the various
grounds for revocation or suspension of
an existing registration which Congress
enumerated in section 304(a), 21 U.S.C.
824(a), are also properly considered
when deciding whether to grant or deny
an application under section 303(f)
because ‘‘ ‘the law would not require an
agency to indulge in the useless act of
granting a license on one day only to
withdraw it on the next.’ ’’ Anthony D.
Funches, 64 FR 14267, 14268 (1999)
(quoting Kuen H. Chen, 58 FR 65401,
65402 (1993)); see also Alan R.
Schankman, 63 FR 45260 (1998). These
include section 304(a)(1), which
provides for the suspension or
revocation of a registration in the event
that the registrant ‘‘has materially
falsified any application filed pursuant
to or required by this subchapter.’’ 21
U.S.C. 824(a)(1). Thus, the allegation
that Respondent materially falsified his
application is properly considered in
this proceeding.
The Government bears the burden of
proof in showing that the issuance of a
registration is inconsistent with the
public interest. 21 CFR 1301.44(d).
However, where the Government has
made out a prima facie case, the burden
shifts to the applicant to ‘‘present[]
sufficient mitigating evidence’’ to show
why he 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
[his] actions and demonstrate that [he]
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 Trong Tran, 63 FR 64280, 62483
(1998); Prince George Daniels, 60 FR
62884, 62887 (1995).
Factor One—The Recommendation of
the State Licensing Board
The Arizona Regulatory Board of
Physician Assistants has made no
recommendation in this matter as to
whether Respondent’s application
should be granted. However, it is
undisputed that Respondent holds a
current Arizona Physician Assistant’s
license and possesses authority under
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State law to dispense controlled
substances. While Respondent therefore
meets an essential prerequisite for
obtaining a registration under the CSA,
21 U.S.C. 823(f), DEA has held
repeatedly that a practitioner’s
possession of State authority is not
dispositive of the public interest
determination. See Mortimer B. Levin,
55 FR 8209, 8210 (1990).
Factors Two, Three, and Four—
Respondent’s Experience in Dispensing
Controlled Substances, Conviction
Record Under Federal and State Laws
for Offenses Related to the
Manufacture, Distribution, or
Dispensing of Controlled Substances,
and Compliance With Applicable Laws
Related to Controlled Substances
As found above, on two prior
occasions, Respondent was convicted of
offenses under Arizona law related to
the distribution of both marijuana (in
1992) and cocaine (in 1994).15
Subsequently, in 1999, both of these
convictions were vacated upon his
having successfully completed
probation.
Given the obvious concerns raised by
his prior criminal conduct, see GX 3, at
2; following Respondent’s obtaining of
his PA license, the Agency granted his
application for a registration on the
condition that he enter into the MOA,
under which he agreed to comply with
several conditions beyond those
imposed by the CSA and DEA
regulations. Of relevance here,
Respondent agreed to maintain, for a
period of five years, a log ‘‘list[ing] all
controlled substances that he
prescribes’’ which was also to ‘‘be
subject to inspection * * * for five
years.’’ GX 3, at 3. In addition,
Respondent ‘‘agree[d] to notify the DEA
Phoenix Division prior to transferring
his * * * [r]egistration to another
address within the state of Arizona or to
another state.’’ Id.
As the ALJ found, Respondent did not
comply with either condition. ALJ at
30–32. When asked to present his log,
he provided a box which contained an
assortment of papers and folders in no
particular order, with some papers
hanging out from the sides of the box.
Moreover, the most recent records were
for the year 2003.
While the meaning of the MOA
provision seems clear, and Respondent
eventually acknowledged that a log is ‘‘a
journal,’’ Tr. 321, even accepting
Respondent’s explanation that he was in
15 It is also noted that in 1985, Respondent was
convicted in Thailand of the offense of Possession
and Attempted Smuggling’’ of marijuana. While this
conviction is not encompassed within factor three,
it is properly considered under factor five.
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compliance by compiling his notes of
patient encounters and the controlled
substance prescriptions, it undisputed
that he did not have a complete record
of his prescribing activities as he lacked
records after the year 2003.16 I therefore
hold that he violated the MOA’s logkeeping provision.
Moreover, while the MOA clearly
stated that Respondent was required to
notify the local DEA office prior to
transferring his registration to another
address, Respondent twice changed his
practice location without notifying the
Agency. Here again, Respondent
violated the terms of the MOA.
However, standing alone, Respondent’s
violations of the MOA would not
warrant the denial of his application
given his expression of remorse.
Alleged Violations of 21 U.S.C.
843(a)(2)
Under the CSA, it is ‘‘unlawful for any
person knowingly or intentionally
* * * to use in the * * * dispensing of
a controlled substance * * * a
registration number which is fictitious,
revoked, suspended, expired, or issued
to another person[.]’’ 21 U.S.C. 843(a)(2)
(emphasis added). Doing so is a felony
offense which is punishable by ‘‘a term
of imprisonment of not more than 4
years, a fine under Title 18, or both.’’ Id.
at § 843(d)(1).
The ALJ found that that ‘‘is
undisputed that Respondent issued
prescriptions for controlled substances
after his DEA registration expired in
June 2003, and that he continued to do
so even after submitting an application
for a new registration.’’ ALJ at 24. While
apparently crediting Respondent’s
testimony that he was not aware that his
registration expired ‘‘until late 2004,’’
the ALJ concluded that ‘‘there is no
doubt that he was aware of its
expiration after that time, and that he
therefore knowingly used an expired
registration in violation of the statute
when he continued to write
prescriptions after late 2004.’’ Id. (citing
21 U.S.C. 843(a)(2)). However, the ALJ
rejected the Government’s contention
that Respondent issued prescriptions
even after the April 2005 meeting
during which a DI told him to stop. Id.
The Government apparently accepts
Respondent’s contention that he did not
know that his registration had expired
until sometime in the fall of 2004 when
he applied for a new registration. See
Gov. Br. 6 (Proposed Finding 11)
(‘‘Respondent testified that he was
unaware that his DEA registration had
expired and wasn’t notified in writing
16 Respondent did not dispute that he prescribed
after 2003.
PO 00000
Frm 00068
Fmt 4703
Sfmt 4703
or otherwise of the expiration.’’).17 The
Government’s contention that
Respondent violated 21 U.S.C. 843(a)(2)
is therefore based on his having issued
prescriptions even after he submitted
his application and clearly knew that
his registration had expired. Id. at 10.
The Government further argues that
‘‘exacerbat[ing] his unlawful conduct,
Respondent continued issuing
prescriptions under his expired * * *
registration after DEA investigators
advised him against doing so during the
* * * April 2005 inspection.’’ Id. at 10–
11.
To prove these allegations, the
Government relied on a data
compilation of his purported
prescriptions, the reliability of which it
failed to establish. As the DI candidly
explained, this data ‘‘was only a
pointing tool’’ and ‘‘was to be verified
against the actual records that’’ a
pharmacy or practitioner is ‘‘required to
maintain’’ under the CSA and DEA’s
regulations. Inexplicably, the
Government did not produce any
reliable evidence showing the
controlled substances prescriptions he
authorized such as patient medical
records, copies of the actual
prescriptions, or pharmacy dispensing
logs. In sum, the Government did not
produce reliable evidence establishing
the extent to which Respondent
continued to prescribe controlled
substances following the expiration of
his registration.
It acknowledged that in a letter to one
of the DIs, Respondent stated that he
had resumed prescribing at some point
following the submission of his
application. Moreover, there is a degree
of inconsistency between Respondent’s
contentions that: (1) His office manager
had contacted someone at DEA
Headquarters and been told that he
could write again; and (2) that he had
a supervising physician co-sign the
prescriptions. Nonetheless, because
there is no reliable proof establishing
the specific prescriptions which
Respondent wrote following his
becoming aware that his registration had
expired, and the Government does not
dispute either the factual basis of his
contention that he had his prescriptions
co-signed or the legality of this practice,
there is insufficient evidence to show
that Respondent violated 21 U.S.C.
843(a)(2). I therefore reject the
17 While the Government established that
Respondent’s registration expired on June 30, 2003,
GX 1, it did not introduce into evidence a copy of
the Certificate of Registration which was issued to
him. Such certificates typically include the
expiration date. Nor does the Government argue
that proof of actual knowledge is not required to
sustain a violation of 21 U.S.C. 843(a)(2).
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Government’s contention (and the ALJ’s
conclusion) that Respondent violated 21
U.S.C. 843(a)(2).
Factor Five—Such Other Conduct
Which May Threaten Public Health and
Safety
Under this factor, the ALJ considered
the allegations that Respondent
materially falsified his 2004 application
and that he had been convicted of
driving under the influence. ALJ at 27–
33. She also deemed it appropriate to
consider Respondent’s ‘‘employment at
a clinic that serves a primarily
underserved and underinsured
population.’’ Id. at 33.18
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The Material Falsification Allegation
As found above, on his 2004
application, Respondent answered ‘‘no’’
to the question: ‘‘Has the applicant ever
been convicted of a crime in connection
with controlled substances under state
or federal law?’’ GX 4, at 1. Moreover,
Respondent left blank the box which the
application provided for explaining a
‘‘yes’’ answer. Id. at 2. By signing the
application, Respondent ‘‘certif[ied] that
the forgoing information furnished on
[the] application [wa]s true and correct.’’
Id.
Respondent does not dispute that he
should have disclosed the two Arizona
convictions on his application. Resp. Br.
at 13 (‘‘It seems obvious that the 2004
application should have included the
same information regarding felony
convictions that [the] 2000 application
had.’’). Indeed, it cannot be disputed
that his answer was false and materially
so given that under the public interest
standard, the Agency is required to
consider, inter alia, both an ‘‘applicant’s
conviction record under Federal or State
laws relating to the manufacture,
distribution, or dispensing of controlled
substances,’’ 21 U.S.C. 823(f)(3), and his
‘‘[c]ompliance with applicable State,
Federal, or local laws relating to
controlled substances.’’ Id. § 823(f)(4).
Given the statutory factors, it is clear
that Respondent’s false answer was
‘‘capable of influencing’’ the decision as
to whether his application should be
granted. See Jackson, 72 FR at 23852
(‘‘ ‘The most common formulation’ of the
concept of materiality is that ‘a
concealment or misrepresentation is
material if it ‘‘has a natural tendency to
influence, or was capable of influencing,
18 She also considered Respondent’s violations of
the MOA under this factor. I conclude, however
that these violations are properly considered in
assessing his experience in dispensing controlled
substances. Moreover, as noted above, Respondent’s
1985 conviction in the Thai courts for possession
and attempting to smuggle marijuana is properly
considered under this factor. However, it is noted
that this conviction is now twenty-five years old.
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the decision of’’ the decisionmaking
body to which it was addressed.’ ’’
(quoting Kungys v. United States, 485
U.S. 759, 770 (1988) (quoting Weinstock
v. United States, 231 F.2d 699, 701 (DC
Cir. 1956))).
That the Agency did not rely on
Respondent’s false statement and grant
his application does not make the
statement immaterial. The Lawsons,
Inc., 72 FR 74334, 74339 (2007) (quoting
United States v. Alemany Rivera, 781
F.2d 229, 234 (1st Cir. 1985) (‘‘It makes
no difference that a specific falsification
did not exert influence so long as it had
the capacity to do so.’’); 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
department of the United States
Government.’’). Nor does it matter that
some employees of the Agency were
previously aware of Respondent’s
criminal history. See The Lawsons, 72
FR at 74339 n.7.
Respondent nonetheless contends that
he did not intentionally falsify the
application, Resp. Br. at 13–14, and the
ALJ credited his testimony that the
office manager at the clinic, where he
was then working, filled out the
application for him and that he signed
it in haste without carefully reviewing
it. ALJ at 8. The ALJ also credited his
testimony that if he had ‘‘personally
filled out the form * * * he would have
detailed the explanation of his past
conduct as he had done in 2000.’’ Id. at
29.
While I accept the ALJ’s credibility
findings, I reject her conclusion that
Respondent was merely ‘‘negligent.’’ Id.
Notably, between the form’s blocks for
signing and printing one’s name, the
form stated: ‘‘I hereby certify that the
forgoing information furnished on this
application is true and correct.’’ GX 4, at
2. Given the certification’s location on
the application, Respondent cannot
credibly claim that he did not read it.
Respondent’s testimony simply begs the
question of what information he thought
he was certifying as being ‘‘true.’’
Likewise, the form’s block for
explaining his answers to the liability
questions was on the same side as the
signature and certification blocks. In
addition, Respondent had previously
completed an application in which he
disclosed his criminal convictions; he
likewise knew, based on the detailed
recitation of his various drug-related
offenses in the MOA (although he
apparently rarely, if ever, reviewed the
MOA), that these offenses were of
particular concern to DEA. Respondent
clearly had reason to know that he was
PO 00000
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Fmt 4703
Sfmt 4703
20019
required to disclose his criminal
convictions to the Agency.
Finally, the ALJ gave insufficient
consideration to the circumstances
surrounding the 2004 renewal. Notably,
this was not a routine renewal. Rather,
at the time it was submitted,
Respondent clearly knew that his
registration had long since expired.
And, notwithstanding his claim that he
was a harried practitioner who was
trying to make an impression with his
employer by seeing numerous patients,
reviewing the form for completeness
would have taken no more than a few
minutes.
I therefore conclude that Respondent
deliberately failed to read the front of
the form. As several courts have noted,
deliberate avoidance is generally not a
defense to an allegation of material
misrepresentation. United States v.
Puente, 982 F.2d 156, 159 (5th Cir.
1993) (‘‘[A] defendant who deliberately
avoids reading the form he is signing
cannot avoid criminal sanctions for any
false statements contained therein.’’);
Hanna v. Gonzales, 128 Fed. Appx. 478,
480 (6th Cir. 2005) (rejecting alien’s
claim that he did not willfully
misrepresent material fact because
friend filled out application for him;
having signed the application under
oath, his ‘‘failure to apprise himself of
the contents of this important document
constituted deliberate avoidance—an act
the law generally does not recognize as
a defense to misrepresentation’’).
The ALJ failed to acknowledge this
line of authority. Instead, she relied on
several Agency decisions and reasoned
that the ‘‘lack of intent to deceive is a
relevant consideration in determining
whether a registrant or applicant should
possess a DEA registration.’’ ALJ at 30
(quoting Rosalind A. Cropper, 66 FR
41040, 41048 (2001)). However, the
cases cited by the ALJ are readily
distinguishable. See id. (citing Samuel
Arnold, 63 FR 8687 (1998); Martha
Hernandez, 62 FR 61145 (1997)).
For instance, in Cropper, the
physician was completely unaware of
the underlying agency action which she
had failed to disclose on her
application. 66 FR at 41048. That is a far
cry from this case as Respondent clearly
knew that he had been previously
convicted of two felony drug offenses in
the Arizona courts.
In Samuel Arnold, a physician failed
to disclose on his application a prior
suspension of his state medical license
based on misconduct which was not
related to controlled substances. 63 FR
at 8687. However, the Deputy
Administrator found credible the
testimony of two witnesses that
Respondent had called a DEA Office on
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a speaker phone to inquire as to whether
he was required to disclose the
suspension and was told by an Agency
employee that he did not have to
because his ‘‘license was no longer
suspended.’’ Id. at 8687–88. Here,
however, Respondent makes no claim
that in filling out the application he
relied on erroneous advice from an
Agency employee as to what he was
required to disclose.
Of the cases cited by the ALJ, only
Martha Hernandez, 62 FR 61145 (1997),
and Theodore Neujahr, 65 FR 5680
(2000), provide any comfort to
Respondent. In Hernandez, while my
predecessor concluded that the
practitioner’s material falsifications in
failing to disclose the suspension by two
States of her medical licenses (for failing
to pay her student loans, which she
believed was not within the intent of the
liability question) ‘‘indicate a careless
disregard for attention to detail,’’ he
imposed only a reprimand and
conditions on her registration. Id. at
61148. While my predecessor agreed
that ‘‘this lack of connection to
controlled substances [wa]s not
dispositive of the matter,’’ he concluded
that it was ‘‘relevant in determining the
appropriate remedy.’’ Id. Here, by
contrast, Respondent’s falsifications
involve his failure to disclose his
convictions for controlled substances
offenses and are clearly relevant in
determining the appropriate
sanction.19 See 21 U.S.C. 823(f)(3).
The ALJ also relied on Neujahr, a case
in which the Agency granted the
application of practitioner,
notwithstanding that he had he had
materially falsified it, because he
‘‘acknowledged that he falsified his
applications, he apparently regretted
that conduct, and [the ALJ] believe[d]
that he will not repeat it.’’ ALJ at 30 &
n.86 (quoting 65 FR at 5682).
Subsequently in her decision, the ALJ
reasoned that while the Government
had ‘‘made out a prima face case for
denying his application, * * * it is
important to note that the [Agency’s]
19 Having reviewed the Agency’s decision in
Neujahr, I conclude that the case was wrongly
decided because the respondent there did not fully
address his misconduct, which included not only
his failure to disclose his having surrendered his
authority under Federal law to write prescriptions
for schedule II controlled substances, but also his
failure to disclose a State proceeding which placed
his veterinary license on probation; at his DEA
hearing, the respondent offered no explanation as
to this separate act of material falsification. 65 FR
at 5681. In Neujahr, the ALJ concluded that the
respondent ‘‘apparently regretted that conduct.’’ Id.
at 5682. To make clear, the Agency should not have
to guess as to whether one has accepted
responsibility for his misconduct. A registrant/
applicant’s acceptance of responsibility must be
clear and manifest.
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decision whether to grant or deny an
application for registration is a
prospective, rather than a retrospective,
determination.’’ Id. at 34.
It is true that proceedings under
section 303 and 304 of the CSA are
remedial and not punitive. See, e. g.,
Jackson, 72 FR at 23853. However,
contrary to the ALJ’s understanding, the
remedial nature of this proceeding does
not preclude the Agency from
considering the deterrent value of a
sanction with respect to both the
Respondent and others in setting the
remedy. See Southwood
Pharmaceuticals, Inc., 72 FR 36487,
36504 (2007). As Southwood makes
clear, ‘‘even when a proceeding serves a
remedial purpose, an administrative
agency can properly consider the need
to deter others from engaging in similar
acts.’’ Id. (citing Butz v. Glover Livestock
Commission Co., Inc., 411 U.S. 182,
187–188 (1973) (upholding Agency’s
authority ‘‘to employ that sanction as in
[its] judgment best serves to deter
violations and achieve the objectives of
[the] statute’’)). The ALJ, however, did
not even acknowledge Southwood.
Contrary to the ALJ’s conclusion that
Respondent will conduct himself
henceforth in a responsible fashion, see
ALJ at 34, Respondent made a similar
promise in the MOA when he agreed to
‘‘abide by its contents in good faith.’’ GX
3, at 3. See also ALRA Laboratories, Inc.
v. DEA, 54 F.3d 450, 452 (7th Cir. 1995)
(‘‘An agency rationally may conclude
that past performance is the best
predictor of future performance.’’).
Respondent, however, then proceeded
to ignore his obligations under the
MOA.
Under these circumstances, granting
Respondent’s application subject to the
restrictions proposed by the ALJ, which
do no more than replicate the
conditions imposed by the MOA,
amounts to no sanction at all. In short,
adopting the ALJ’s proposed sanction
would send the wrong message to both
Respondent, who has demonstrated a
disturbing lack of attention to the
requirements of being a registrant, as
well as other applicants/registrants,
especially those who would submit an
application without carefully reviewing
it for completeness and truthfulness.
Accordingly, I conclude that
Respondent’s application should be
denied. However, given Respondent’s
expression of remorse, I conclude that
Respondent can re-apply for a new
registration six months from the
effective date of this Order. Provided
that his application is not materially
false and that he has committed no
other acts which would warrant the
denial of his application, the Agency
PO 00000
Frm 00070
Fmt 4703
Sfmt 4703
will expeditiously grant his renewal
application and issue him a new
registration subject to the conditions of
the 2001 MOA.20
Order
Pursuant to the authority vested in me
by 21 U.S.C. 823(f), as well as 28 CFR
0.100(b) and 0.104, I order that the
application of Mark De La Lama for a
DEA Certificate of Registration as a midlevel practitioner be, and it hereby is,
denied. This order is effective May 11,
2011.
Dated: April 1, 2011.
Michele M. Leonhart,
Administrator.
[FR Doc. 2011–8536 Filed 4–8–11; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Glenn D. Krieger, M.D.; Denial of
Application
On August 31, 2009, the Deputy
Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration, issued an Order to
Show Cause to Glenn D. Krieger, M.D.
(‘‘Applicant’’), of West Bloomfield,
Michigan. The Show Cause Order
proposed the denial of Applicant’s
application for a DEA Certificate of
Registration on the ground that his
‘‘registration would be inconsistent with
the public interest as defined by 21
U.S.C. §§ 823(f) and 824(a)(4).’’ Show
Cause Order, at 1.
More specifically, the Show Cause
Order alleged that Applicant filed an
20 I place no weight on Respondent’s DUI/Hit and
Run conviction there being no evidence that he was
under the influence of a controlled substance at the
time. See David E. Trawick, 53 FR 5326, 5327
(1988) (noting that factor five encompasses
‘‘wrongful acts relating to controlled substances
committed by a registrant outside of his
professional practice but which relate to controlled
substances’’).
The ALJ also opined that it is appropriate to
consider Respondent’s employment at a clinic that
serves an ‘‘underserved and underinsured
populations.’’ ALJ at 33. However, I have previously
rejected this reasoning noting that ‘‘[t]he public
interest standard of 21 U.S.C. 823(f) is not a
freewheeling inquiry but is guided by the five
specific factors which Congress directed the
Attorney General to consider [and that]
consideration of the socioeconomic status of a
practitioner’s patient population is not mandated by
the text of either 21 U.S.C. 823(f) or 824(a)(4),
which focus primarily on the acts committed by a
practitioner.’’ Gregory D. Owens, 74 FR 36751,
36757 (2009). I further noted that such a rule is
‘‘unworkable,’’ and ‘‘would inject a new level of
complexity into already complex proceedings and
take the Agency far afield of the purpose of the
CSA’s registration provisions, which is to prevent
diversion.’’ Id. at n.22. I therefore do not consider
the issue.
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[Federal Register Volume 76, Number 69 (Monday, April 11, 2011)]
[Notices]
[Pages 20011-20020]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-8536]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 07-20]
Mark De La Lama, P.A.; Denial of Application
On January 16, 2007, the Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement Administration, issued an Order to
Show Cause to Mark De La Lama (Respondent), of Phoenix, Arizona. The
Show Cause Order proposed the denial of Respondent's application for a
DEA Certificate of Registration as a mid-level practitioner (i.e.,
physician assistant) on various grounds.
Specifically, the Show Cause Order made four major allegations
against Respondent. First, the Order alleged that Respondent's former
DEA registration had expired on June 30, 2003, but that Respondent had
continued writing prescriptions for controlled substances after that
date. ALJ Ex. 1, at 1 & 3. Next, noting that as a condition of his
initial registration Respondent had entered into a Memorandum of
Agreement (MOA) with the Agency, the Order alleged that Respondent had
violated the MOA in two ways: First, by failing to produce the log of
his controlled substance prescriptions which he was required to
maintain when DEA Diversion Investigators (DIs) visited his practice
premises on April 13, 2005, and; second, by failing to report two
changes of his practice location. Id. at 1, 2-3. Finally, the Order
alleged that on November 21, 2004, Respondent submitted a new
application for a registration which he falsified by failing to
disclose his April 1992 and October 1994 felony convictions for
offenses related to controlled substances, as well as the existence of
the MOA. Id. at 3.
Respondent, through his counsel, requested a hearing. The matter
was assigned to a DEA Administrative Law Judge (ALJ), who conducted a
hearing on January 16, 2008, in Phoenix, Arizona. ALJ at 2. Both
parties called witnesses to testify and introduced documentary evidence
into the record. Following the hearing, both parties filed briefs
containing their proposed findings of fact, conclusions of law and
argument. Id.
On April 2, 2009, the ALJ issued her Recommended Decision. Therein,
the ALJ concluded that Respondent ``knowingly issued prescriptions for
controlled substances using an expired DEA registration number over a
span of nearly two years'' but that the ``lack of evidence that
Respondent issued prescriptions for other than a legitimate purpose * *
* weigh[s] in favor of a finding that Respondent's registration would
not be inconsistent with the public interest.'' Id. at 26.
The ALJ also found that Respondent's conviction record for two
felonies under Arizona law involving controlled substances weighed ``in
favor of a finding that Respondent's registration would be inconsistent
with the public interest.'' Id. at 27. Based on his failure to disclose
these two felonies on his November 21, 2004 application, the ALJ
further found that Respondent materially falsified his application but
concluded that his conduct was only negligent because an office manager
had completed the form for him. Id. at 28-29. The ALJ credited
``Respondent's testimony and * * * his expressions of regret and
recognition of his wrongdoing on this specific point, and * * *
therefore conclude[d] that his material falsification in the 2004
application [did] not warrant denying his application.'' Id. at 30.
Next, the ALJ found ``that Respondent failed to adhere to certain
requirements contained'' in a Memorandum of Agreement (MOA) which he
was required to enter into with the Agency as a condition of obtaining
a registration. Id. More specifically, Respondent ``failed to maintain
a log of all controlled substances that he prescribed as of the date of
the April 2005 site visit'' and he failed to notify the Agency of his
changes in the location of his practice address. Id. 30-31. The ALJ
also found, however, that Respondent ``equally accepts responsibility
for what went wrong[ ] and has demonstrated a commitment to cooperate
with DEA in the future.'' Id. at 32. Moreover, while the ALJ noted that
Respondent had been convicted (in 1985) in Thailand of possession and
attempted smuggling of marijuana, as well as a more recent conviction
for driving under the influence, the ALJ also noted that Respondent was
then practicing ``at a clinic that serves a primarily underserved and
underinsured population'' and that this is ``an appropriate
consideration in determining whether [his] application * * * should be
granted.'' Id. at 33.
Based on his multiple convictions for controlled substances
offenses and his ``considerable difficulty [in] adhering to some of the
requirements of the'' MOA, the ALJ concluded that the Agency had ``made
out a prima facie case for denying [Respondent's] application.'' Id.
The ALJ reasoned, however, that ``[d]espite his criminal convictions
involving controlled substances in the 1990s, Respondent appears to
have put that period of his life behind him.'' Id. at 34.
[[Page 20012]]
In the ALJ's view, Respondent's ``most recent conviction involving
controlled substances occurred more than fifteen years ago [and]
[s]ince that time, he has neither been implicated in nor been convicted
of any other crime involving controlled substances [and] [t]he
Government presented no evidence that the future would hold any
differently.'' Id. Based on his ``expression of remorse and his
expressed willingness to comply with restrictions on his
registration,'' the ALJ ``conclude[d] that the public interest would
best be served by granting Respondent a restricted registration''
subject to four conditions. Id. These were that: (1) Respondent must
comply with all Federal, State and local laws and regulations relating
to controlled substances; (2) Respondent may not personally use
controlled substances in any form or for any reason without a
prescription issued by a duly licensed physician who possesses a valid
DEA Certificate of Registration; (3) Respondent must permit DEA
personnel to enter his practice location at any time during normal
business hours, without prior notice, to verify compliance with all
applicable laws and regulations relating to controlled substances, as
well as with any or all restrictions imposed on Respondent as a
condition of his registration with the DEA; and (4) Respondent must
notify the DEA Phoenix Division, in writing, of any change of business
address or employer. Id. at 34-35.
Neither party filed exceptions to the ALJ's decision. On May 7,
2009, the ALJ forwarded the record to me for a final agency action.
During the initial review of the record, it was noted that the
Government had introduced into evidence--over Respondent's objection--a
printout of a data compilation prepared by SearchPoint, a private
entity, which purportedly listed the prescriptions Respondent issued
between October 8, 2003 and May 23, 2005. The Government introduced
this document, which is not a record required to be maintained under
either federal or state law, to prove the allegations that Respondent
had issued controlled substance prescriptions even after he knew his
registration had expired and had done so even after being told to stop
by DEA Investigators. Because Respondent's objection went to the
foundation for admitting the compilation and the reliability of the
information it contains, and the Government did not establish that the
methods used to compile the data were sufficiently trustworthy, I
remanded the case to the ALJ for further proceedings and specifically
instructed the Government to address various questions as set forth in
the remand order.\1\ Following additional proceedings, the ALJ
forwarded the record back to me for final agency action.
---------------------------------------------------------------------------
\1\ To make clear, I remanded the case because there was no
prior Agency decision addressing the admissibility of data
compilations prepared by private entities.
---------------------------------------------------------------------------
Having considered the entire record, I hereby issue this Decision
and Final Order. I agree with the ALJ's conclusions that: (1)
Respondent materially falsified his application, (2) that he has a
significant history of convictions relating to controlled substances;
(3) that he failed to meet the MOA's requirements with respect to both
his proper keeping of a log and his obligation to notify the Agency of
any changes in his practice location.\2\ As the ALJ recognized, these
findings establish a prima facie case for the denial of his
application.
---------------------------------------------------------------------------
\2\ Under the express terms of the MOA, Respondent agreed to
surrender his registration without issuance of an Order to Show
Cause in the event that he failed to comply with the MOA. GX 3, at
3. Also, a violation of the MOA's terms would ``result in the
initiation of proceedings to revoke'' Respondent's registration. Id.
---------------------------------------------------------------------------
However, I reject the ALJ's conclusion that Respondent's employment
at a clinic that serves an underserved population is ``an appropriate
consideration in determining whether [his] application * * * should be
granted.'' ALJ at 33; see also Gregory D. Owens, 74 FR 36751, 36756-57
(2009) (rejecting consideration of socioeconomic status of
practitioner's patients as appropriate consideration under the CSA).
Moreover, while I do not reject the ALJ's findings that Respondent has
accepted responsibility for his misconduct, I reject her proposed
sanction because it clearly rests on a fundamental misunderstanding as
to the scope of permissible sanctions under the CSA. Given the
circumstances of this matter, I conclude that Respondent's application
should be denied at this time.
The Reliability of the SearchPoint Data Compilation
Before proceeding to make factual findings, it is necessary to
resolve the issue of whether the ALJ properly admitted--over
Respondent's objection that the Government had not laid a proper
foundation--Government Exhibit 8, which it represents to be a data
compilation listing the prescriptions Respondent issued between October
8, 2003 and May 23, 2005.\3\ The Government argues that this exhibit
showed that Respondent had issued controlled substance prescriptions
not only following the expiration of his registration, but also after
he knew it had expired and even after he was told by DEA Investigators
to stop doing so.\4\ Gov. Proposed Findings at 7-8, 10-11. The ALJ
relied on this evidence, in part, in her decision.
---------------------------------------------------------------------------
\3\ The ALJ overruled the objection after determining that the
Exhibit had been provided to Respondent in advance of the hearing
even though Respondent's counsel had objected on grounds of lack of
foundation and that ``we have no way of determining the accuracy of
the information as set forth herein.'' Tr. 66. While under the
Agency's regulation, ``[t]he authenticity of all documents submitted
in advance [is] deemed admitted unless written objection thereto is
filed with the presiding officer,'' 21 CFR 1316.59(c), there is no
such rule applicable to objections based on a lack of foundation.
The ALJ apparently confused these two independent grounds for
objecting to the admission of evidence.
\4\ Notably, the Government did not introduce into evidence
either copies of any prescriptions Respondent wrote during this
period, or pharmacy dispensing logs, even though such evidence
should have been readily obtainable (as a pharmacy is required to
keep such records for two years, see 21 CFR1304.04(a) and
1304.22(c)), and is what the Government customarily uses in these
proceedings to establish that a practitioner wrote unlawful
prescriptions.
---------------------------------------------------------------------------
Under the Administrative Procedure Act (APA), an Order must be
``supported by and in accordance with the reliable, probative and
substantial evidence.'' 5 U.S.C. 556(d). While the Agency's decision
may be based on hearsay evidence, see Richardson v. Perales, 402 U.S.
389, 410 (1971), such evidence must still be reliable.
The compilation is not, however, a record maintained by a
government agency. Nor is it a record which is required to be
maintained under either federal or state law. Moreover, on reviewing
the compilation, there appeared to be various discrepancies which
called into question the data's reliability. As I noted in the remand
order, this Office is unaware of any judicial decisions either
admitting or excluding similar data compilations prepared by
SearchPoint.
At the hearing, a DI testified that prescription information is
entered by a pharmacy into a computer which is then collected and sent
to SearchPoint. Tr. 43. The DI did not, however, explain the basis of
his knowledge. Moreover, the record did not establish the procedures or
methods used by the pharmacies in entering the information, when the
information is entered, whether either the pharmacies or SearchPoint
have any procedures to verify the accuracy of the information, whether
the data is properly secured, and whether there are procedures to
protect the data from manipulation. Cf. McCormick on Evidence Sec.
314, at 886 (3d ed. 1984).
[[Page 20013]]
The record also did not establish whether a prescription that was
signed by both Respondent and a supervising physician (which was one of
Respondent's defenses to the allegation that he continued to prescribe
even after he realized his registration had expired) would be
attributed to Respondent or the physician. Nor did the record establish
why, where refills were authorized by a single prescription, the
printout provided the same date for the date the prescription was
written and the date it was dispensed.
Because the record did not adequately establish the procedures or
methods used to compile this database and that the compilation is
sufficiently trustworthy so as to satisfy the APA's requirement that
the evidence be reliable, I remanded the case to the ALJ with
instructions to address these various concerns. I also expressly
ordered that the questions ``must be addressed by a witness who has
personal knowledge of the procedures and methods used by Searchpoint.''
Remand Order at 3.
On remand, the Government submitted an affidavit of the same
Diversion Investigator whose testimony I previously found to be
inadequate for establishing that the SearchPoint data is reliable. From
his affidavit, it is clear that the DI lacks personal knowledge of the
procedures and methods used by SearchPoint. See Affidavit of Miguel
Rodriguez.
This, by itself, is reason to conclude that the Government has
failed to comply with the remand order. However, even in his affidavit,
the DI offered no evidence which establishes that the SearchPoint data
is reliable. To the contrary, the DI explained that:
[t]he accuracy and authenticity of the data was only as good as the
accuracy of the pharmacy reporting. It was stipulated to all DEA
investigators, that SearchPoint was only a pointing tool and the
data provided by SearchPoint was to be verified against actual
records that the pharmacy, distributor, [or] practitioner was
required to maintain by current regulations and laws.''
Id. at 4 (emphasis added).
The DI further acknowledged that he ``did not verify the
information found during the query of the SearchPoint database prior to
meeting with [Respondent] on April 13, 2005.'' Id. at 4-5. (Indeed, it
is apparent that the DIs did not verify the information even after
meeting with Respondent as there are no ``actual records'' in
evidence.) The DI's statement that the SearchPoint data was only to be
used as a ``pointing tool'' begs the question of why the actual
pharmacy (or Respondent's patient) records were never obtained.
Based on the DI's assertion that the SearchPoint database was ``a
valuable tool in DEA's investigative efforts,'' id. at 5, ``the
Government respectfully request[ed] an additional finding that the
SearchPoint data proved useful in DEA's investigation of Respondent,
and helped further the objectives of DEA's investigation.'' Gov't
Memorandum on Remand at 2. Contrary to the Government's understanding,
whether the SearchPoint data proved useful in its investigation is not
material to the resolution of any issue in this proceeding.
As the Government's brief makes clear, determining the extent of
Respondent's issuance of prescriptions after his registration expired
and assessing his culpability in doing so is one of the central issues
in this matter. Given that there was no clear agency precedent
addressing the admissibility of similar data compilations, this
proceeding was remanded to determine whether the SearchPoint data was
sufficiently reliable to prove that Respondent had continued to issue
controlled substance prescriptions not only after he became aware that
his registration had expired, but also after he was told by a DI to
stop doing so.
Notwithstanding that the remand order clearly stated what the
Government was required to show to establish that this evidence is
reliable, it failed to do so. Because the Government failed to comply
with the remand order and offers no valid excuse for its failure to do
so, I conclude that the SearchPoint compilation is not competent
evidence and should have been excluded. See 21 CFR 1316.59(a) (``The
presiding officer shall admit only evidence that is competent,
relevant, material and not unduly repetitious.''). Accordingly, as
ultimate factfinder, I do not base any of my findings on it.
Findings
Respondent is a physician assistant, who is licensed by the Arizona
Regulatory Board of Physicians Assistants (The Board). GXs 6 & 7. At
the time of the hearing, Respondent was 49 years of age. Tr. 286.
Respondent obtained a Bachelor of Science degree in human biology
in 1997 and a Master's degree in physician assistant studies in October
1999. Id. at 208. After obtaining his state license, Respondent
commenced working as a physician assistant; his duties involve
performing physical exams, making diagnoses, treating patients,
interpreting test results, and ordering diagnostic tests and studies.
Id.
On October 26, 2000, Respondent applied for a DEA registration to
handle controlled substances in Schedules II through V as a mid-level
practitioner. GX 2. On the application, Respondent was required to
answer four ``liability questions''; the questions included whether the
applicant had ever been convicted of an offense related to controlled
substances under either federal or state law. Id. at 2.
Respondent answered in the affirmative and provided an explanation
of the circumstances surrounding a 1992 marijuana conviction. Id.
Respondent wrote that in 1989 or 1990, a friend he met in karate class
was involved in ``selling dope'' and that Respondent ``made the
horrible mistake of trying to make a `fast buck.' '' Id. Respondent
also stated on the application that ``I entered guilty pleas in 1992
and have never violated any of the terms of my probation.'' Id.
Respondent also stated on the application that his ``criminal
convictions were expunged by the Maricopa County Superior Court in
1999,'' based on the recommendation of his probation officer. Id. He
also ``regret[ted] this experience in [his] life'' and that his ``goal
was to be the best P.A. and father I can be.'' Id.
On February 12, 2001, the Agency granted Respondent's application.
GX 1. However, because of his prior conviction, the Agency issued him a
restricted registration; as a condition of his registration, Respondent
was required to enter into a Memorandum of Agreement (MOA), which
imposed various conditions on his registration. Tr. 19; GX 3.
The MOA further detailed Respondent's drug-related offenses, which
included two other drug convictions, one of which should clearly have
been disclosed on his application, but was not. On May 3, 1985,
Respondent was convicted in Bangkok, Thailand for ``Possession and
Attempted Smuggling'' of approximately 145 grams of marijuana. GX 3, at
1. The court suspended the 21-month sentence, and Respondent paid a
fine and completed two years of probation. Id.
On or about April 10, 1992, Respondent entered into a plea
agreement in which he pled guilty to ``Attempted[] Possession, Use,
Production, Sale and Transportation'' of approximately eight pounds of
marijuana, a class 3 felony under Arizona law. Id. Respondent paid a
fine, was jailed for two months, and was placed on five years'
probation.\5\ Id.
[[Page 20014]]
With respect to this incident, Respondent maintained at the hearing
that he ``was approached by somebody'' and ended up being ``a fall
guy.'' Tr. 284.
---------------------------------------------------------------------------
\5\ On June 16, 1999, the Maricopa County Superior Court vacated
the judgment of guilt and restored Respondent's civil rights. Id. at
2. This is the felony that he listed on his application in 2000.
---------------------------------------------------------------------------
On October 24, 1994, Respondent was found guilty of ``Conspiracy to
Transfer, Sell or Possess'' a narcotic drug, a class 2 felony under
Arizona law, based on his involvement in a conspiracy to illegally
import cocaine from Panama to the United States. GX 3, at 2. Respondent
was fined and sentenced to seven years' probation, but the probation
was subsequently reduced.\6\ Id. With respect to this conviction,
Respondent maintained at the hearing that he was not ``directly
involved'' in the conspiracy because he only ``had phone conversations
with the particular individual,'' but he nevertheless pled guilty. Id.
at 288-90.
---------------------------------------------------------------------------
\6\ The Superior Court also apparently vacated this conviction
in 1999, when it restored Respondent's civil rights. Tr. 210.
---------------------------------------------------------------------------
Respondent did not disclose this conviction on his initial
application. GX 2, at 2; Tr. 293. When questioned as to why, Respondent
stated that he ``suppose[d]'' that it was because of ``inadvertence''
on his part and added that ``[i]t was all at the same time,''
apparently referring to the marijuana distribution offense. Tr. 293.
As found above, as a condition of his registration, Respondent
entered into an MOA, under which he agreed to comply with various
conditions. The MOA was to remain in effect for five years from the
date of signing, January 25, 2001, during which time the DEA would be
able to monitor Respondent's handling of controlled substances. Tr.
115-16; GX 3, at 2.
As relevant to the allegations in this proceeding, Respondent
agreed ``to maintain a log for five years, which will list all
controlled substances that he prescribes.'' GX 3, at 2. The log was
``subject to inspection by DEA for five years from the date'' the MOA
was ``fully executed,'' which was January 30, 2001. Id. at 2-3.
Second, Respondent agreed ``that DEA personnel may enter his place
of practice at any time during regular business hours, without prior
notice, to verify compliance'' with the MOA. Id. at 3. Finally,
Respondent agreed ``to notify the DEA Phoenix Division prior to
transferring his DEA Certificate of Registration to another address
within the state of Arizona or to another state.'' Id. In the MOA,
Respondent indicated that he would be registered at the location of
3201 West Peoria Avenue, Suite A-202, Phoenix, Arizona. Id. at 1.
In October 2000, Respondent began working as a physician assistant
under the supervision of a Dr. John Curtin, at the above address. Tr.
223. Sometime thereafter, Respondent contracted pneumonia and missed
substantial time from work; upon his return, his hours were reduced.
Id. at 224. Consequently, in 2001 or 2002, Respondent left this
position and went to work for William Zachow, D.O., who owned 21st
Century Family Medicine (21st Century), 6707 North 19th Ave., Suite
201, Phoenix, Arizona. Id. at 167-68, 224. Respondent did not notify
DEA of this change of practice address, as required by the MOA.\7\ Tr.
38-39.
---------------------------------------------------------------------------
\7\ Respondent also testified that the year 2001 was a difficult
year: In May his father fell from a roof and was hospitalized for 21
days with a brain hemorrhage before he finally died; Respondent took
in three more dependents into his household as a result of his
father's death; later that year, Respondent developed pneumonia, and
when he returned to work his employer noticed he was depressed and
referred him to counseling; then the national crisis of September
11, 2001 happened. Tr. 220-221. Respondent testified that ``there
was a lot of stuff that happened in 2001 that I think I was a little
bit confused, just overwhelm[ed].'' Id. at 221. While this sequence
of events may have overwhelmed Respondent, and provide some basis
for excusing his failure to notify the Agency of his having changed
his location, it is not a credible explanation for his failure to
renew his registration, which did not expire until June 30, 2003.
---------------------------------------------------------------------------
As part of Respondent's employment agreement at 21st Century, the
clinic was to handle matters related to his licensing fees, his
malpractice coverage and his DEA registration. Id. at 224.
Specifically, Sonia Zachow, Dr. Zachow's wife, ``would take care of the
fees and all the licensing and the DEA.'' Id. at 224-25. Respondent
testified that this was a verbal agreement, as it had originally been
with his first employer, Dr. John Curtin, and that he trusted Dr.
Zachow to honor the agreement. Id. at 219. Respondent testified that
``[f]rom my understanding, all my mail went to [Sonia Zachow] and
through her. I didn't receive any.'' Id. at 225. In particular,
Respondent testified that he never received a notification from DEA
that his registration would expire after June 30, 2003. Id. Given that
he had not notified the Agency of his new address, this is hardly
surprising.
Shirley Reigle, a medical assistant at 21st Century, testified that
she was employed at the clinic when Respondent was hired and that she
worked with Respondent for four or five years. Id. at 168, 193. Ms.
Reigle testified that she managed the ``back office,'' coordinating the
activities of the medical assistants, while Sonia Zachow managed the
``front office,'' or business office. Id. at 169-71. Mrs. Zachow's
responsibilities included the renewal of the licenses and DEA
registrations held by the clinic's physicians and physician assistants,
the renewal of insurance coverage and the billing of insurance claims.
Id. at 171, 174, 176. According to Ms. Reigle, Mrs. Zachow's
responsibilities further included notifying the DEA if a physician or
physician assistant moved his or her location of practice. Id. at 188.
However, in one instance prior to Respondent's employment at 21st
Century, Ms. Reigle tried to induce Mrs. Zachow to give notice of a
move but ended up having to provide the information to DEA herself. Id.
at 204-05.
Respondent's DEA registration expired June 30, 2003. Id. at 42; GX
1. According to Ms. Reigle, sometime in late 2003, Mrs. Zachow entered
the office that Ms. Reigle shared with Respondent and threw a bill from
the DEA onto Respondent's desk, saying, ``Why should I pay his DEA
license when we're selling the practice.'' Tr. 176-77, 181. Ms. Reigle
testified that she believed that Respondent ``had gone for the day''
and that, when she told Respondent about the incident later and he went
to his desk to look, the bill was no longer on his desk. Id. at 177,
199. While Ms. Reigle testified that she told Respondent about the
incident, he apparently took no action to determine whether he still
held a valid registration.
Respondent testified that he did not receive notice that his
registration required renewal and that, had he known, he would not have
continued to practice without it. Id. at 225. Respondent admitted,
however, that at the time he received his registration he knew it was
subject to renewal in three years. Id. at 301. He further asserted that
he did not keep track of the time or display his registration
certificate and that he expected the office manager to handle matters
pertaining to his licenses, as that was done for all incoming health
care providers. Id. Respondent did, however, acknowledge that he was
ultimately responsible for renewing his registration. Id. at 220.
Respondent left 21st Century sometime between July and October
2004, when Dr. Zachow sold the clinic.\8\ Id. at 217. Respondent began
practicing at the 51st Avenue Clinic (51st Avenue), which is located at
4700 North 51st Street, Suite 6, in Phoenix. Id.; GX 4, at 1.\9\
---------------------------------------------------------------------------
\8\ As was much of his testimony regarding the dates of various
events, Respondent's testimony as to the date when he left 21st
Century and commenced working at the 51st Avenue clinic was vague.
\9\ Respondent used the address of this clinic on his 2004
application. GX 4.
---------------------------------------------------------------------------
When the clinic did not offer him adequate hours, Respondent
resumed
[[Page 20015]]
working on a part-time base at 21st Century and split his time between
the two clinics. Tr. 217-18. Sometime in October 2004, Respondent
received a letter from the Arizona Physician's Assistants Board
notifying him that his ``license had lapsed [on] October 1, 2004.'' GX
9, at 4.
Respondent testified that during the period in which he moved to
the new practice, pharmacies were not honoring the prescriptions he
wrote at his new employer, and that his ``office was getting calls for
the prescriptions that [he] had been writing, and they were talking
about a DEA number.'' Tr. 226-27. Notwithstanding the phone calls,
Respondent maintained that he did not know that the registration had
``lapsed'' until three or four months later when, in November 2004 or
early 2005, he was ``contacted by DEA.'' Id. at 226-27. In November
2004, Ms. Muniz, the office manager at 51st Avenue, told Respondent
that he needed to reapply for a DEA registration.\10\ Id. at 228.
---------------------------------------------------------------------------
\10\ In a letter he faxed to a DI on April 24, 2005, Respondent
indicated that in October of 2004, he ``received a letter stating
that my P.A. license had expired'' and that after ``doing some
investigation, it turn[ed] out [that] my fees had not been paid.''
GX 9, at 1. Sometime around the time that he got his state license
reinstated, he ``got a call from the former office manager stating
that I had better check up on my malpractice fees. It turn[ed] out
those had not been paid in over a year.'' Id. Moreover, in the same
October time period, his new clinic ``was getting calls back from
the pharmacy saying that my DEA license was no longer valid'' but
that he did not think too much about it at first as ``I didn't know
that the license could expire.'' Id. at 2.
---------------------------------------------------------------------------
According to Respondent, Ms. Muniz filled out the application for
him and showed him only the signature page, which he signed without
reviewing. Id. at 228-29, 262-63, 309-10. As with his previous
application, the form asked Respondent whether he had ``ever been
convicted of a crime in connection with controlled substances under
state or federal law?'' GX 4, at 1; ALJ Ex. 3, at 3. The ``no'' answer
was circled on the application. GX 4, at 1. Moreover, Respondent left
blank the box which the form provided for explaining a ``yes'' answer
to this question, and which is on the same page as the signature block.
Id. at 2. The application was then submitted.
As to why he did not disclose his convictions, Respondent
testified: ``I was busy. I was probably seeing 50 patients a day. I was
trying to make an impression.'' Tr. 228. According to Respondent, had
Ms. Muniz given him the entire application, he would have given a
detailed explanation and an answer of ``yes'' to the liability
question, just as he had done on his October 2000 application. Id. at
229.
The ALJ specifically credited Respondent's testimony that he would
not have provided a ``no'' answer ``had he personally filled out the
form'' and that ``he would have detailed the explanation of his past
conduct as he had done in 2000.'' ALJ at 29. The ALJ further credited
Respondent's ``expressions of regret and recognition of his
wrongdoing'' in submitting the application. Id. at 30. The Government
did not except to these findings.
It is undisputed that after filing his application, Respondent
continued to write prescriptions for controlled substances under his
expired registration even though he then clearly knew that it had
expired and did so through at least March 2005. See GX 9, at 4; see
also Resp. Prop. Findings at 6-7. Respondent offered two main (and
somewhat inconsistent) explanations for why he continued to write
prescriptions during this period.
First, in a written statement he provided to an Agency investigator
in April 2005, Respondent claimed that ``after reapplying'' there was
``some confusion * * * as to what was going on at that time, some
months went by and [he] was informed by the clinic's office manager
that she had taken care of everything and it was okay to write again.''
GX 9, at 4. Continuing, Respondent explained that Ms. Muniz had
contacted someone ``at DEA headquarters and he had informed her that we
had filled out the incorrect application and our money had been posted
to the wrong account, he said he would fax over the correct application
to be filled out immediately and faxed back.'' Id. Respondent
maintained that employees had said that ``the money would be posted to
the correct account and this would make the license active at this
point.'' Id. Respondent faxed in the new application on February 17,
2005. Id.
Respondent further asserted that he ``wrote very few prescriptions
during this time [when he] was waiting for a copy of the new license.''
Id. According to Respondent, ``[a]fter several weeks of not receiving
[the] paperwork[,] we called again and were informed that there was a
problem.'' Id. Respondent added that ``[a]t this time I discontinued
completely and left the controlled substances, the few we do write up
to the responsibility of my supervising physicians.'' Id. at 5.
Finally, Respondent claimed that while he could not ``recall the very
last prescription I wrote, it probably was over a month or two ago and
was some cough syrup with codeine as I wrote very little in the first
place.'' Id.
Second, in his testimony, Respondent further claimed that he ``was
getting co-signatures on the prescriptions if I did need to write or
just having them written altogether by a supervising physician.'' Tr.
230. Respondent explained that the co-signed prescriptions would be
``[o]ne prescription, my name and the doctor's name, usually above
mine.'' Id. at 231. Respondent also asserted that the pharmacy ``might
have run it [the prescription] as my DEA, but actually the doctor, the
supervising physician, it was under his DEA as well if his signature''
was on the prescription. Id. Respondent further asserted that he had
``some copies'' available that would show that his prescriptions were
being co-signed. Id.
Respondent submitted a letter (which is unsworn) dated April 22,
2005 written by Ms. Muniz, Director of Operations for the 51st Ave.
Family Clinic. RX 8. According to the letter, Respondent submitted a
renewal application sometime around December 3, 2004, when the payment
for the application fee cleared. Id. However, after several months,
Respondent had still not gotten his registration. Id. According to Ms.
Muniz, she then called DEA Headquarters and was told that Respondent
had submitted the wrong form. Id. The employee at DEA Headquarters then
faxed over the correct form which Respondent then submitted. Id.
According to Ms. Muniz, the employee told her that he would post the
previous payment to the correct account and this would activate
Respondent's registration. Id. However, according to an affidavit of a
DEA Diversion Investigator, ``there is no record of'' Respondent's
having submitted an application after November 21, 2004. Affidavit of
Miguel Rodriguez, at 6.
Based on Respondent's ``no'' answer on his 2004 application to the
liability question regarding whether he had any prior convictions for
controlled substances offenses, a DI commenced an investigation. Tr.
93. The DI reviewed the records from the Agency's prior investigation,
police reports and the MOA. Id. at 93-95. He also learned that, in
September 2003, Respondent had been arrested in Florida for a hit-and-
run incident while driving under the influence.\11\ Id. at 103.
---------------------------------------------------------------------------
\11\ There was no evidence presented that Respondent was under
the influence of a controlled substance at the time of the incident.
Tr. 256. Moreover, there is no evidence in this record that
Respondent has recently abused controlled substances. I therefore
conclude that the incident has little relevance to the issues in
this proceeding and deem it unnecessary to make further findings.
---------------------------------------------------------------------------
[[Page 20016]]
Using Respondent's registration number, the DI also conducted a
search of Respondent's controlled substance prescriptions using the
SearchPoint database. Id. at 42-44, 76. The data indicated that
Respondent had written controlled substance prescriptions after the
expiration of his registration (June 30, 2003). Id. at 42-43. However,
the DI testified that after reviewing the data, he did not have any
concerns about Respondent's prescribing other than that he lacked a
registration. Tr. 152.
On April 13, 2005, as part of his investigation of Respondent's
application, the DI and his senior partner visited Respondent at the
51st Avenue clinic, which was the address Respondent had given on his
application. Tr. 30-31. However, this address was different from
Respondent's address of record on file with the Agency, as Respondent
had not notified the Agency that he had changed his practice location
and had therefore violated the MOA. Id. at 31.
According to the DI, Respondent was not authorized to handle
controlled substances at the 51st Avenue clinic. Id. at 33. The DI
testified that, although failing to notify DEA of a change of address
is not typically the sole basis for revoking a DEA registration,
Respondent's failure to comply with the address-change provision of the
MOA gave cause for particular concern. Id. at 109. However, the
Government produced no evidence that Respondent had done anything other
than write prescriptions at this address.
During the visit, the DI did not observe Respondent working under
the supervision of a physician, and Respondent did not inform him or
his partner that he was working under physician supervision. Id. at 31-
32. The DIs then asked to inspect the log which Respondent was required
to maintain under the MOA. Id. at 33. Respondent left the room and
returned with a box containing an assortment of papers and several
folders in no particular order. Id. at 33-34. Respondent partially
attributed the disorganization of his ``log'' to the fact that he was
in the process of moving into a new practice while continuing to work
part-time at the other such that each location had its own records. Id.
at 327. Yet, at this point, he had been at 51st Avenue clinic for at
least six months.
According to the DI, his partner examined the contents of the box
and asked whether Respondent had records more recent than those for the
year 2003. Id. at 35-36, 124-25, 160-61. Respondent answered that he
could ``put something together,'' thus indicating that he was not
currently keeping a log. Id. at 36, 125. However, the DIs did not take
the box to copy the contents and ``never asked for a copy.'' Id. at
249, 251. Respondent later testified that ``I had it together and I'd
have produced--I even took a ledger and * * * copied them all down so I
did have a log book of the individual entries.'' \12\ Id. at 251.
---------------------------------------------------------------------------
\12\ Copies of this document were apparently offered as
Respondent's Exhibit 2. However, the Government objected to the
admission of the exhibit on the ground that it was not timely
exchanged, and the ALJ sustained the objection.
---------------------------------------------------------------------------
In a subsequent conversation, Respondent offered the material to
the DI to which the latter responded: `` `No, I'll give [the letters]
you have already provided to me to Washington and it will go from
there.' '' Id. The DI admitted that he and his partner did not ask for
copies of the materials in the box and did not offer Respondent the
option to submit later the materials that he would gather together. Id.
at 128.
Respondent testified that he had photocopied his notes of ``patient
encounters,'' which contained ``the patient's name, date of birth,
everything that we're seeing about that patient on that day and the
reasonable explanation of why you would write a controlled substance
for that patient on that day'' as well as the controlled substance
prescriptions he had written and then placed the copies in a manila
folder in a box. Id. at 216, 235, 239. Respondent testified that he
thought this would be ``even better than a logbook.'' Id. at 216, 235.
As he explained:
Now I thought that if there was ever a question about my writing
abilities and what I was doing, that I could pull up the patient
encounter and show my reasonable action on why I would write a
prescription on that particular day for that particular patient. So
I thought it was actually better than a logbook.
Id. at 236.\13\
---------------------------------------------------------------------------
\13\ At the hearing, Respondent attempted to enter copies of
this ``log'' into evidence as Respondent's Exhibit 1, but the
Government objected on the ground that the documents had not been
timely provided to the Government. Id. at 242-43, 248. The ALJ's
sustained the objection and rejected the evidence. Id. at 248.
The parties disputed whether what Respondent had presented to the
DIs constituted a log. According to the DI, a log is ``something that
we could easily obtain and review to check and verify [Respondent's]
prescription habits,'' which would normally be a ``bound book with
notations'' or a ``binder with prescriptions.'' Tr. 34-35. The DI
testified that he did not consider the records in the box to be
``easily reviewable.'' Id. at 36. However, he later conceded that the
MOA did not specify what format the log was to be maintained in and
that the information he sought could be obtained from the copies of the
prescriptions. Id. at 36, 122.
Respondent testified that he ``[p]robably'' did not ``completely''
understand the MOA's requirement. Id. at 215. However, he also
testified that ``[a] log is actually a journal reading; it's a
journal.'' Id. at 321. Respondent then testified that he thought ``that
a patient list was even better [and] was the same thing as a log
book.'' Id. He also maintained that ``there was nothing in the [MOA]
that told me how * * * a patient log book should look,'' but then
acknowledged that he never inquired of the Agency what the log should
consist of ``[b]ecause [he] thought that from what [he] had seen with
other physicians, what they used was a photo- a three- or double--you
know, the two-sided prescriptions where you just get a copy of it,
that's what I'd seen.'' Id. at 322.
Respondent further testified that, while initially he kept the
copies of prescriptions and patient encounters in a box in the office
in chronological order, when he moved from 21st Century to 51st Avenue
in October 2004, he placed the records from the new location in another
box. Id. at 217, 237. Thus, at the meeting on April 13, 2005, he was
only able to produce a portion of the prescriptions he had written as
the remaining records were at 21st Century. Id. at 235-38.
The DIs discussed with Respondent the MOA's requirement that he
notify the DEA before transferring his registration to another address.
Id. at 37; GX 3, at 3. Respondent told them that he was not sure
whether he had notified the Agency of his most recent move, and he
acknowledged that he had moved to 51st Avenue approximately six months
earlier. Tr. 38-39. He also told the DIs that he had worked at 21st
Century for four years prior to the move to 51st Avenue and that this
address was also different from the address at which he had originally
been registered. Id. at 38-39, 154; RXs 6 & 8. Respondent provided the
DIs with two changes of address: 4700 North 51st Avenue, Suite 6,
Phoenix, Arizona, and 1526 West Glendale Avenue, Suite 109, Phoenix,
Arizona. Tr. 38-39. Although he testified that it was ultimately his
responsibility to advise the DEA that he had changed his practice
address, Respondent maintained that it had been the responsibility of
Mrs. Zachow to do so. Id. at 188 & 190.
The DIs also discussed with Respondent the fact that his DEA
[[Page 20017]]
registration had expired. Tr. 59. Respondent told them that he had
learned that the registration had expired several months before their
meeting. Id. at 59, 113-14. Respondent further told the investigators
that the office manager (Sonia Zachow) had been responsible for
renewing the registration and had failed to do so. Id. at 112, 114-15.
During the April 13, 2005 meeting, the DI's senior partner
instructed Respondent to desist from writing prescriptions for
controlled substances; Respondent agreed that he would not write
prescriptions for controlled substances. Id. at 62-63, 78.
At the hearing, Respondent testified that he had complied with the
DI's instruction. Id. at 345. More specifically, Respondent testified
that ``I've been compliant from the day when I said--when they told me
you can't write controlled substances I've been--not written one.'' Id.
A DI testified that sometime after May 23, 2005, he conducted a
second search of Respondent's DEA registration number on SearchPoint
and found that Respondent had written controlled substance
prescriptions after the April 13, 2005, meeting. Tr. 77. However, for
reasons explained above, because the Government did not comply with the
instructions in the remand order for establishing that the SearchPoint
data is reliable, I conclude that the Government has not proved that
Respondent violated the DI's order to stop writing prescriptions. I
further find that the Government has failed to produce any reliable
evidence rebutting Respondent's contention that he had his
prescriptions co-signed by a supervising physician after he became
aware that his registration had expired.\14\
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\14\ The Government does not address whether this practice is
even permissible under Arizona law.
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At the hearing, Respondent testified that he was compliant with the
MOA; that his work as a physicians assistant was difficult and
stressful; that he had no training in office administration; and that
he had learned how to be a ``better professional'' from this experience
with his DEA registration expiring. Tr. 257-59.
Respondent testified that, although he currently works as a
physicians assistant without writing controlled substance
prescriptions, his lack of authority to do so significantly diminishes
his employer clinic's ability to treat patients: he is the only health
care provider at the current clinic and cannot prescribe drugs
necessary to treat such common ailments as excessive weight, Attention
Deficit Disorder/Attention Deficit-Hyperactivity Disorder, acute pain,
acute anxiety attacks, and testosterone deficiencies. Id. at 267 & 278.
If he cannot substitute a non-controlled substance, he must refer a
patient who requires a controlled substance to a physician or another
facility. Id. at 273.
According to Respondent, in around July 2005, his boss at the 51st
Avenue clinic gave him two weeks to resolve the issues surrounding his
DEA registration and told him he would lose his job if he did not do so
because insurance companies use the DEA registration number as a
tracking number for reimbursement. Id. at 259-60. Respondent
subsequently lost his job at this clinic but subsequently gained
employment at his current clinic. Id. at 260.
Respondent further testified that he had ``made a lot of mistakes''
and that he did not ``plan on this happening again.'' Id. at 267.
Respondent added that he could not ``afford to make any mistakes in
[his] life anymore,'' that he had ``made plenty'' and was ``sorry'' to
have ``made them'' and was ``remorseful.'' Id. at 268. He further
stated that while ``I made countless errors here * * * I've learned
from them and I don't think I'll ever see a courtroom again.'' Id.
Discussion
Section 303(f) of the Controlled Substances Act (CSA) provides that
an application for a practitioner's registration may be denied upon a
determination ``that the issuance of such registration would be
inconsistent with the public interest.'' 21 U.S.C. 823(f). In making
the public interest determination, the CSA requires 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.
These factors may be considered in the disjunctive, and I ``may
rely on any one or a combination of factors and may give each factor
the weight [I] deem[] appropriate'' in determining whether an
application for registration should be denied. Robert A. Leslie, 68 FR
15227, 15230 (2003). Moreover, I am ``not required to make findings as
to all the factors.'' Hoxie v. DEA, 419 F.3d 477, 482 (6th Cir. 2005);
see also Morall v. DEA, 412 F.3d 165, 173-74 (DC Cir. 2005).
Under DEA precedent, the various grounds for revocation or
suspension of an existing registration which Congress enumerated in
section 304(a), 21 U.S.C. 824(a), are also properly considered when
deciding whether to grant or deny an application under section 303(f)
because `` `the law would not require an agency to indulge in the
useless act of granting a license on one day only to withdraw it on the
next.' '' Anthony D. Funches, 64 FR 14267, 14268 (1999) (quoting Kuen
H. Chen, 58 FR 65401, 65402 (1993)); see also Alan R. Schankman, 63 FR
45260 (1998). These include section 304(a)(1), which provides for the
suspension or revocation of a registration in the event that the
registrant ``has materially falsified any application filed pursuant to
or required by this subchapter.'' 21 U.S.C. 824(a)(1). Thus, the
allegation that Respondent materially falsified his application is
properly considered in this proceeding.
The Government bears the burden of proof in showing that the
issuance of a registration is inconsistent with the public interest. 21
CFR 1301.44(d). However, where the Government has made out a prima
facie case, the burden shifts to the applicant to ``present[]
sufficient mitigating evidence'' to show why he 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 [his] actions
and demonstrate that [he] 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 Trong Tran, 63 FR 64280,
62483 (1998); Prince George Daniels, 60 FR 62884, 62887 (1995).
Factor One--The Recommendation of the State Licensing Board
The Arizona Regulatory Board of Physician Assistants has made no
recommendation in this matter as to whether Respondent's application
should be granted. However, it is undisputed that Respondent holds a
current Arizona Physician Assistant's license and possesses authority
under
[[Page 20018]]
State law to dispense controlled substances. While Respondent therefore
meets an essential prerequisite for obtaining a registration under the
CSA, 21 U.S.C. 823(f), DEA has held repeatedly that a practitioner's
possession of State authority is not dispositive of the public interest
determination. See Mortimer B. Levin, 55 FR 8209, 8210 (1990).
Factors Two, Three, and Four--Respondent's Experience in Dispensing
Controlled Substances, Conviction Record Under Federal and State Laws
for Offenses Related to the Manufacture, Distribution, or Dispensing of
Controlled Substances, and Compliance With Applicable Laws Related to
Controlled Substances
As found above, on two prior occasions, Respondent was convicted of
offenses under Arizona law related to the distribution of both
marijuana (in 1992) and cocaine (in 1994).\15\ Subsequently, in 1999,
both of these convictions were vacated upon his having successfully
completed probation.
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\15\ It is also noted that in 1985, Respondent was convicted in
Thailand of the offense of Possession and Attempted Smuggling'' of
marijuana. While this conviction is not encompassed within factor
three, it is properly considered under factor five.
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Given the obvious concerns raised by his prior criminal conduct,
see GX 3, at 2; following Respondent's obtaining of his PA license, the
Agency granted his application for a registration on the condition that
he enter into the MOA, under which he agreed to comply with several
conditions beyond those imposed by the CSA and DEA regulations. Of
relevance here, Respondent agreed to maintain, for a period of five
years, a log ``list[ing] all controlled substances that he prescribes''
which was also to ``be subject to inspection * * * for five years.'' GX
3, at 3. In addition, Respondent ``agree[d] to notify the DEA Phoenix
Division prior to transferring his * * * [r]egistration to another
address within the state of Arizona or to another state.'' Id.
As the ALJ found, Respondent did not comply with either condition.
ALJ at 30-32. When asked to present his log, he provided a box which
contained an assortment of papers and folders in no particular order,
with some papers hanging out from the sides of the box. Moreover, the
most recent records were for the year 2003.
While the meaning of the MOA provision seems clear, and Respondent
eventually acknowledged that a log is ``a journal,'' Tr. 321, even
accepting Respondent's explanation that he was in compliance by
compiling his notes of patient encounters and the controlled substance
prescriptions, it undisputed that he did not have a complete record of
his prescribing activities as he lacked records after the year
2003.\16\ I therefore hold that he violated the MOA's log-keeping
provision.
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\16\ Respondent did not dispute that he prescribed after 2003.
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Moreover, while the MOA clearly stated that Respondent was required
to notify the local DEA office prior to transferring his registration
to another address, Respondent twice changed his practice location
without notifying the Agency. Here again, Respondent violated the terms
of the MOA. However, standing alone, Respondent's violations of the MOA
would not warrant the denial of his application given his expression of
remorse.
Alleged Violations of 21 U.S.C. 843(a)(2)
Under the CSA, it is ``unlawful for any person knowingly or
intentionally * * * to use in the * * * dispensing of a controlled
substance * * * a registration number which is fictitious, revoked,
suspended, expired, or issued to another person[.]'' 21 U.S.C.
843(a)(2) (emphasis added). Doing so is a felony offense which is
punishable by ``a term of imprisonment of not more than 4 years, a fine
under Title 18, or both.'' Id. at Sec. 843(d)(1).
The ALJ found that that ``is undisputed that Respondent issued
prescriptions for controlled substances after his DEA registration
expired in June 2003, and that he continued to do so even after
submitting an application for a new registration.'' ALJ at 24. While
apparently crediting Respondent's testimony that he was not aware that
his registration expired ``until late 2004,'' the ALJ concluded that
``there is no doubt that he was aware of its expiration after that
time, and that he therefore knowingly used an expired registration in
violation of the statute when he continued to write prescriptions after
late 2004.'' Id. (citing 21 U.S.C. 843(a)(2)). However, the ALJ
rejected the Government's contention that Respondent issued
prescriptions even after the April 2005 meeting during which a DI told
him to stop. Id.
The Government apparently accepts Respondent's contention that he
did not know that his registration had expired until sometime in the
fall of 2004 when he applied for a new registration. See Gov. Br. 6
(Proposed Finding 11) (``Respondent testified that he was unaware that
his DEA registration had expired and wasn't notified in writing or
otherwise of the expiration.'').\17\ The Government's contention that
Respondent violated 21 U.S.C. 843(a)(2) is therefore based on his
having issued prescriptions even after he submitted his application and
clearly knew that his registration had expired. Id. at 10. The
Government further argues that ``exacerbat[ing] his unlawful conduct,
Respondent continued issuing prescriptions under his expired * * *
registration after DEA investigators advised him against doing so
during the * * * April 2005 inspection.'' Id. at 10-11.
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\17\ While the Government established that Respondent's
registration expired on June 30, 2003, GX 1, it did not introduce
into evidence a copy of the Certificate of Registration which was
issued to him. Such certificates typically include the expiration
date. Nor does the Government argue that proof of actual knowledge
is not required to sustain a violation of 21 U.S.C. 843(a)(2).
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To prove these allegations, the Government relied on a data
compilation of his purported prescriptions, the reliability of which it
failed to establish. As the DI candidly explained, this data ``was only
a pointing tool'' and ``was to be verified against the actual records
that'' a pharmacy or practitioner is ``required to maintain'' under the
CSA and DEA's regulations. Inexplicably, the Government did not produce
any reliable evidence showing the controlled substances prescriptions
he authorized such as patient medical records, copies of the actual
prescriptions, or pharmacy dispensing logs. In sum, the Government did
not produce reliable evidence establishing the extent to which
Respondent continued to prescribe controlled substances following the
expiration of his registration.
It acknowledged that in a letter to one of the DIs, Respondent
stated that he had resumed prescribing at some point following the
submission of his application. Moreover, there is a degree of
inconsistency between Respondent's contentions that: (1) His office
manager had contacted someone at DEA Headquarters and been told that he
could write again; and (2) that he had a supervising physician co-sign
the prescriptions. Nonetheless, because there is no reliable proof
establishing the specific prescriptions which Respondent wrote
following his becoming aware that his registration had expired, and the
Government does not dispute either the factual basis of his contention
that he had his prescriptions co-signed or the legality of this
practice, there is insufficient evidence to show that Respondent
violated 21 U.S.C. 843(a)(2). I therefore reject the
[[Page 20019]]
Government's contention (and the ALJ's conclusion) that Respondent
violated 21 U.S.C. 843(a)(2).
Factor Five--Such Other Conduct Which May Threaten Public Health and
Safety
Under this factor, the ALJ considered the allegations that
Respondent materially falsified his 2004 application and that he had
been convicted of driving under the influence. ALJ at 27-33. She also
deemed it appropriate to consider Respondent's ``employment at a clinic
that serves a primarily underserved and underinsured population.'' Id.
at 33.\18\
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\18\ She also considered Respondent's violations of the MOA
under this factor. I conclude, however that these violations are
properly considered in assessing his experience in dispensing
controlled substances. Moreover, as noted above, Respondent's 1985
conviction in the Thai courts for possession and attempting to
smuggle marijuana is properly considered under this factor. However,
it is noted that this conviction is now twenty-five years old.
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The Material Falsification Allegation
As found above, on his 2004 application, Respondent answered ``no''
to the question: ``Has the applicant ever been convicted of a crime in
connection with controlled substances under state or federal law?'' GX
4, at 1. Moreover, Respondent left blank the box which the application
provided for explaining a ``yes'' answer. Id. at 2. By signing the
application, Respondent ``certif[ied] that the forgoing information
furnished on [the] application [wa]s true and correct.'' Id.
Respondent does not dispute that he should have disclosed the two
Arizona convictions on his application. Resp. Br. at 13 (``It seems
obvious that the 2004 application should have included the same
information regarding felony convictions that [the] 2000 application
had.''). Indeed, it cannot be disputed that his answer was false and
materially so given that under the public interest standard, the Agency
is required to consider, inter alia, both an ``applicant's conviction
record under Federal or State laws relating to the manufacture,
distribution, or dispensing of controlled substances,'' 21 U.S.C.
823(f)(3), and his ``[c]ompliance with applicable State, Federal, or
local laws relating to controlled substances.'' Id. Sec. 823(f)(4).
Given the statutory factors, it is clear that Respondent's false answer
was ``capable of influencing'' the decision as to whether his
application should be granted. See Jackson, 72 FR at 23852 (`` `The
most common formulation' of the concept of materiality is that `a
concealment or misrepresentation is material if it ``has a natural
tendency to influence, or was capable of influencing, the decision of''
the decisionmaking body to which it was addressed.' '' (quoting Kungys
v. United States, 485 U.S. 759, 770 (1988)