Tamika Mayo, M.D.; Decision and Order, 69681-69685 [2021-26533]
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[FR Doc. 2021–26535 Filed 12–7–21; 8:45 am]
BILLING CODE 4830–01–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Tamika Mayo, M.D.; Decision and
Order
On July 23, 2019, the Assistant
Administrator, Diversion Control
Division, Drug Enforcement
Administration (hereinafter, DEA or
Government), issued an Order to Show
Cause (hereinafter, OSC) to Tamika
Mayo, M.D. (hereinafter, Respondent),
of Baton Rouge, Louisiana. Request for
Final Agency Action (hereinafter,
RFAA), Exhibit (hereinafter RFAAX) A
(OSC), at 1 and 5. The OSC proposed to
revoke Respondent’s DEA Certificate of
Registration, Control No. BM7946835
and to deny any pending applications
for a new registration or for renewal
pursuant to 21 U.S.C. 824(a)(4) and
823(f), because Respondent had
‘‘committed acts which render [her]
registration inconsistent with the public
interest.’’ Id. at 1.
The OSC alleged that Respondent had
issued thousands of prescriptions for
controlled substances in Louisiana
during periods when her Louisiana
Controlled Dangerous Substance
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(hereinafter, CDS) license was expired.
Id. at 2–3. Specifically, the OSC alleged
that between September 1, 2016, and
January 17, 2017, Respondent issued
over 1,850 prescriptions for controlled
substances while her CDS license was
expired; between September 1, 2017,
and June 13, 2018, Respondent issued
over 1,730 prescriptions for controlled
substances while her CDS license was
expired; and between September 1,
2018, and February 15, 2019,
Respondent issued over 400
prescriptions for controlled substances
while her CDS license was expired. Id.
According to the OSC, because
Respondent was not authorized to issue
prescriptions for controlled substances
during these periods, the prescriptions
were issued in violation of state and
federal law. Id. at 3 (citing La. Stat.
§§ 40:967(A)(1)(a) & 40:973; La. Admin.
Code tit. 46, §§ 2705 & 2707(B)(3)–(4);
21 U.S.C. 841(a)(1); 21 CFR 1306.03 &
1306.04). The OSC concluded that ‘‘[b]y
issuing more than 3,900 prescriptions
for controlled substances without state
authorization, and therefore in violation
of state and federal law, [Respondent
has] committed such acts as would
render [her] continued registration
inconsistent with the public interest.’’
Id. (citing 21 U.S.C. 824(a)(4) & 823(f)(2)
& (4)).
The OSC notified Respondent of the
right to request a hearing on the
allegations or to submit a written
statement, while waiving the right to a
hearing, the procedures for electing each
option, and the consequences for failing
to elect either option. Id. at 4 (citing 21
CFR 1301.43). The OSC also notified
Respondent of the opportunity to
submit a corrective action plan. Id. at 4–
5 (citing 21 U.S.C. 824(c)(2)(C)).
By letter dated August 17, 2019,
Respondent offered an explanation in
response to the allegations and stated
that she was ‘‘not waving [sic] [her]
right to a hearing.’’ RFAAX B. On
August 20, 2019, Administrative Law
Judge Mark M. Dowd (hereinafter, the
ALJ) issued an Order Directing
Clarification, in which the ALJ
instructed Respondent, if she was
seeking a hearing, to ‘‘submit a
document affirmatively and
unconditionally requesting a hearing’’
and stated that if the new document was
timely filed, the initial filing would be
deemed a timely hearing request.
RFAAX C, at 3. By email dated August
27, 2019, Respondent requested a
hearing. RFAAX D. On August 28, 2019,
the ALJ issued an Order for Prehearing
Statements. RFAAX E, at 1. The
Government timely filed its prehearing
statement on September 9, 2019. Id. at
2. On September 30, 2019, the ALJ
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issued an Order Terminating
Proceedings, in which the ALJ found
that based on Respondent’s failure to
comply with the Order for Prehearing
Statements, ‘‘Respondent has implicitly
withdrawn her request for a hearing’’
and ordered the proceedings terminated.
Id. at 4. The ALJ noted that Respondent
had contacted the Office of
Administrative Law Judges on
September 20, 2019, and in response
she had received: Specific instructions
on where to call if she had questions, an
additional copy of the Order for
Prehearing Statements and an additional
request for Respondent to provide a
phone number where she could be
reached for the conference, which she
never provided. Id. at 2. On October 2,
2019, Respondent sent multiple emails
to the Tribunal offering an explanation
and requesting that the proceedings be
reopened. ALJX 13–17. However, on
October 2, 2019, the ALJ issued an
Order Denying Respondent’s Request to
Reopen These Proceedings, in which the
ALJ found that Respondent had not
demonstrated sufficient good cause to
reopen the matter. RFAAX F, at 4. I have
reviewed and agree with the procedural
rulings of the ALJ.
On March 30, 2020, the Government
forwarded its RFAA, along with the
evidentiary record for this matter, to my
office. Having considered the record in
its entirety, I find that the record
established, by substantial evidence,
that Respondent committed acts that
render her continued registration
inconsistent with the public interest.
Accordingly, I conclude that the
appropriate sanction is to revoke
Respondent’s DEA registration and to
deny any pending applications for
renewal or new registration in
Louisiana. I make the following findings
of fact.
I. Findings of Fact
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A. Respondent’s DEA Registration
Respondent is registered with the
DEA as a practitioner authorized to
handle controlled substances in
schedules II–V under DEA registration
number BM7946835 at 4336 North
Blvd., Suite 101, Baton Rouge, LA
70806. RFAAX G–1. Respondent filed a
renewal of her DEA registration ‘‘on or
about December 5, 2019.’’ RFAAX G, at
1.1
1 It appears from Agency records that
Respondent’s registration is in retired status,
although it is unclear exactly what precipitated that
status. Regardless, the fact that a registration has
expired during the pendency of an OSC does not
impact my jurisdiction or prerogative under the
Controlled Substances Act (hereinafter, CSA) to
adjudicate the OSC to finality. Jeffrey D. Olsen,
M.D., 84 FR 68474 (2019). Adjudicating this matter
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B. Government’s Case
The Government’s RFAA includes 18
attached exhibits consisting of copies of
hearing procedural documents and
orders, a declaration from a DEA
Diversion Investigator (hereinafter, DI),
a copy of Respondent’s DEA certificate
of registration, various documents
pertaining to the status of Respondent’s
Louisiana CDS license, and various
prescription records from Respondent.
See RFAAX A–G–11.
In a Declaration dated February 27,
2020, a DI assigned to the New Orleans
Field Division described the service of
the OSC on Respondent as well as the
investigation activities involved in the
current matter, including the collection
of the Government’s exhibits. RFAAX G,
at 1–4.
On November 3, 2016, the Louisiana
Board of Pharmacy (hereinafter, the
Board) provided Respondent with a
Termination Notice, notifying her that
her CDS license had been terminated
because she had failed to renew her
license within 30 days after its
expiration on September 1, 2016.
RFAAX G–3. Respondent’s CDS license
remained in an expired status until it
was renewed, effective January 17, 2017.
RFAAX G–2 (Expiration Summary
Memo from the Louisiana Board of
Pharmacy, dated June 27, 2019).2
Nonetheless, from September 1, 2016, to
January 17, 2017, Respondent issued
approximately 1,850 prescriptions for
controlled substances in the State of
Louisiana. RFAAX G–6 and G–9.
On November 3, 2017, the Board
provided Respondent with a second
Termination Notice, notifying her that
her CDS license had been terminated,
because she had failed to renew her
license within 30 days after its
expiration on September 1, 2017.
RFAAX G–4. Respondent’s CDS
licensed remained in an expired status
until it was renewed, effective June 13,
2018. RFAAX G–2. Nonetheless, from
to finality will create an official record the Agency
can use in any future interactions with Respondent.
As additionally noted in Olsen, ‘‘a final
adjudication is a public record of the Agency’s
expectations for current and prospective members
of that community,’’ and adjudications inform
stakeholders, such as legislators and the public,
about the Agency’s work and allow them to provide
feedback to the Agency, thereby helping shape how
the Agency carries out its responsibilities under the
CSA. Id. Adjudicating this matter to finality will
create a public record to educate current and
prospective registrants about the Agency’s
expectations regarding the responsibilities of
registrants under the CSA and allow stakeholders
to provide feedback regarding the Agency’s
enforcement priorities and practices.
2 According to the Expiration Summary Memo,
the Board was only able to verify periods of
expiration after 2007 because prior to 2007, the CDS
program was overseen by another agency. Id.
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September 1, 2017, to June 13, 2018,
Respondent issued approximately 1,730
prescriptions for controlled substances
in the State of Louisiana. RFAAX G–7
and G–10.
On November 6, 2018, the Board
provided Respondent with a third
Termination Notice, notifying her that
her CDS license had been terminated
because she had failed to renew her
license within 30 days after its
expiration on September 1, 2018.
RFAAX G–5. Respondent’s CDS
licensed remained in an expired status
until it was renewed, effective February
15, 2019. RFAAX G–2. Nonetheless,
from September 1, 2018, to February 15,
2019, Respondent issued approximately
400 prescriptions for controlled
substances in the State of Louisiana.
RFAAX G–8 and G–11.
II. Discussion
A. Government’s Position
In its RFAA, the Government sought
to revoke Respondent’s DEA registration
and to deny any pending applications
for renewal or modification of
Respondent’s DEA registration because
Respondent ‘‘[had] committed acts
which render her continued registration
inconsistent with the public interest, in
violation of 21 U.S.C. 824(a) and
823(f).’’ RFAA, at 1. Specifically, the
Government argued that Respondent
had repeatedly violated state and federal
law by issuing thousands of
prescriptions for controlled substances
while she lacked the authority to do so
due to the expiration of her Louisiana
CDS license. Id. at 7–11. The
Government concluded its RFAA by
requesting that Respondent’s DEA
registration be revoked and that any
pending applications for modification or
renewal of Respondent’s DEA
registration be denied. Id. at 11.
B. Respondent’s Position
The only statements from Respondent
regarding the allegations appear in the
initial letter that Respondent submitted
in response to the OSC, which offers
some explanation as to her misconduct,
but offers no supporting evidence or
ability for me to assess the credibility of
her unsworn statements. See RFAAX B.
In her letter, Respondent stated that, as
to the first period when she was issuing
prescriptions while her license was
expired, she was under a lot of stress
due to an ongoing divorce and from
working two jobs. Id. Respondent stated
that she did not know that her license
was expired, and that ‘‘when [she] was
notified in early 2017 that the license
had expired, [she] immediately got it
renewed.’’ Id. As to the second period
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when she was issuing prescriptions
while her license was expired,
Respondent stated that due to personal
family issues, ‘‘[she] wasn’t even
thinking about the CDS license since
[she] knew [she] had just gotten it
renewed in the early part of the year
2017.’’ Id. Respondent again stated that
she did not realize her license was
expired, and that as soon as she was
notified in early 2018 that the license
was expired, she immediately got it
renewed. Id. Respondent did not offer
an explanation as to the third period
when she was issuing prescriptions
while her license was expired. Id.
Respondent noted that she has
practiced medicine in Louisiana for 20
years, she has never had a problem with
her CDS license, her medical license has
never expired, and her DEA license has
never expired. Id. Respondent stated
that her misconduct was unintentional
and that because ‘‘[she] was commuting
and not in the office every day, [she]
missed the renewal dates.’’ Id.
Respondent also noted that she was
‘‘under horrible levels of stress’’ and
apologized for ‘‘the license having
expired’’, stating that it would ‘‘never
happen again.’’ Respondent concluded
her letter by describing corrective action
that she had taken, specifically that she
had ‘‘logged the expiration date in
several places, even on [her] personal
cell phone’’ and that she was ‘‘renewing
on the date that [she receives] the
renewal letter.’’ Id. Respondent also
stated that she had already completed
the most recent renewal in July 2019. Id.
Finally, Respondent stated that she was
‘‘not waving [sic] [her] right to a
hearing’’ and that ‘‘[i]f the DEA wish[ed]
to pursue [the matter] after [her]
explanation, [she] still would like to
come to a hearing.’’ Id.
As for Respondent’s failure to comply
with the Order for Prehearing
Statements that led to the termination of
the proceedings without a hearing,
Respondent offered some explanation in
her subsequent emails to the Tribunal,
in which she requested that the
proceedings be reopened. See ALJX 13–
17. Specifically, Respondent stated that
she did not realize that she had to
provide additional documents, noting
that she did not have a lawyer and was
unfamiliar with the course of the
proceedings. ALJX 17.
I do not find this explanation
regarding her noncompliance with the
proceedings to be persuasive. As the
ALJ noted in the Order Denying
Respondent’s Request to Reopen These
Proceedings, the Respondent was given
clear instructions in the Order for
Prehearing Statements to file a
Prehearing Statement, as well as the
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logistics and deadlines for doing so.
RFAAX F, at 2–3; see also ALJX 5.
Further, ‘‘the Respondent’s argument
that she does not have a lawyer and is
not familiar with these proceedings does
not provide sufficient cause for her
failure to file a Prehearing Statement.’’
RFAAX F, at 3; see also ALJX 17. There
was also ample evidence that the
instructions to provide a telephone
number were clear and that the date to
file a prehearing statement was clear.
See ALJX 5, at 2–4. Respondent also was
in receipt of the Government’s
Prehearing Statement, so it would be
difficult for her to credibly argue
ignorance as to what a prehearing
statement was. See ALJX 6 (Email:
Government’s Pre-Hearing Statement).
Respondent’s statements in her
hearing request notably do not refute the
allegations in the OSC; therefore, I find
that the facts in the record remain
uncontested.
C. Analysis
Under Section 304 of the CSA, ‘‘[a]
registration . . . to . . . dispense a
controlled substance . . . may be
suspended or revoked by the Attorney
General upon a finding that the
registrant . . . has committed such acts
that would render his [or her]
registration under section 823 of this
title inconsistent with the public
interest as determined by such section.’’
21 U.S.C. 824(a)(4). In the case of a
‘‘practitioner,’’ defined in 21 U.S.C.
802(21) to include a ‘‘physician,’’
Congress directed the Attorney General
to consider the following factors in
making the public interest
determination:
(1) The recommendation of the
appropriate State licensing board or
professional disciplinary authority.
(2) The applicant’s experience in
dispensing, or conducting research with
respect to 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. 21
U.S.C. 823(f).
The DEA considers these public
interest factors in the disjunctive. Robert
A. Leslie, M.D., 68 FR 15227, 15230
(2003). Each factor is weighed on a caseby-case basis. Morall v. Drug Enf’t
Admin., 412 F.3d 165, 173–74 (D.C. Cir.
2005). Any one factor, or combination of
factors, may be decisive. David H. Gillis,
M.D., 58 FR 37507, 37508 (1993). Thus,
there is no need to enter findings on
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each of the factors. Hoxie v. Drug Enf’t
Admin., 419 F.3d 477, 482 (6th Cir.
2005). Furthermore, there is no
requirement to consider a factor in any
given level of detail. Trawick v. Drug
Enf’t Admin., 861 F.2d 72, 76–77 (4th
Cir. 1988). The balancing of the public
interest factors ‘‘is not a contest in
which score is kept; the Agency is not
required to mechanically count up the
factors and determine how many favor
the Government and how many favor
the registrant. Rather, it is an inquiry
which focuses on protecting the public
interest. . . .’’ Jayam Krishna-Iyer,
M.D., 74 FR 459, 462 (2009). When
deciding whether registration is in the
public interest, the DEA must consider
the totality of the circumstances. See
generally Joseph Gaudio, M.D., 74 FR
10083, 10094–95 (2009) (basing sanction
on all evidence on record).
The Government has the burden of
proving that the requirements for
revocation of a DEA registration in 21
U.S.C. 824(a) are satisfied. 21 CFR
1301.44(e). When the Government has
met its prima facie case, the burden
then shifts to the Respondent to show
that revoking registration would not be
appropriate, given the totality of the
facts and circumstances on the record.
Med. Shoppe-Jonesborough, 73 FR 364,
387 (2008).
While I have considered all of the
public interest factors,3 the
Government’s case invoking the public
interest factors of 21 U.S.C. 823(f) seeks
revocation of Respondent’s registration
based solely under Public Interest
Factors Two and Four. I find that the
Government’s evidence with respect to
Factors Two and Four satisfies its prima
3 As to Factor One, there is no evidence in the
record of any recommendation from Respondent’s
state licensing board or professional disciplinary
authority. 21 U.S.C. 823(f)(1). ‘‘The fact that the
record contains no evidence of a recommendation
by a state licensing board does not weigh for or
against a determination as to whether continuation
of Respondent’s DEA certification is consistent with
the public interest.’’ Roni Dreszer, M.D., 76 FR
19434, 19444 (2011).
As to Factor Three, there is no evidence in the
record that Respondent has been convicted of an
offense under either federal or state law ‘‘relating
to the manufacture, distribution, or dispensing of
controlled substances.’’ 21 U.S.C. 823(f)(3).
However, as Agency cases have noted, there are a
number of reasons why a person who has engaged
in criminal misconduct may never have been
convicted of an offense under this factor, let alone
prosecuted for one. Dewey C. MacKay, M.D., 75 FR
49956, 49973 (2010). Agency cases have therefore
found that ‘‘the absence of such a conviction is of
considerably less consequence in the public interest
inquiry’’ and is therefore not dispositive. Id.
As to Factor Five, the Government’s allegations
fit squarely within the parameters of Factors Two
and Four and do not raise ‘‘other conduct which
may threaten the public health and safety.’’ 21
U.S.C. 823(f)(5). Accordingly, Factor Five does not
weigh for or against Respondent.
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facie burden of showing that
Respondent’s continued registration
would be ‘‘inconsistent with the public
interest.’’ 21 U.S.C. 824(a)(4).
Specifically, I find that the record
contains substantial evidence that
Respondent violated both Louisiana
state law and federal law when she
issued thousands of prescriptions for
controlled substances in Louisiana
during periods when she lacked state
authorization to do so. I further find that
Respondent failed to provide evidence
to rebut the Government’s prima facie
case.
1. Factors Two and Four
The DEA often analyzes Factors Two
and Four together. See, e.g., Fred
Samimi, M.D., 79 FR 18698, 18709
(2014); John V. Scalera, M.D., 78 FR
12092, 12098 (2013). Under Factor Two,
the DEA analyzes a registrant’s
‘‘experience in dispensing controlled
substances.’’ 21 U.S.C. 823(f)(2). Factor
Two analysis focuses on a registrant’s
acts that are inconsistent with the
public interest, rather than on a
registrant’s neutral or positive acts and
experience. Randall L. Wolff, M.D., 77
FR 5106, 5121 n.25 (2012) (explaining
that ‘‘every registrant can undoubtedly
point to an extensive body of legitimate
prescribing over the course of [the
registrant’s] professional career’’
(quoting Jayam Krishna-Iyer, M.D., 74
FR 459, 463 (2009))). Similarly, under
Factor Four, the DEA analyzes an
applicant’s compliance with federal and
state controlled substance laws. 21
U.S.C. 823(f)(4). The Factor Four
analysis focuses on violations of state
and federal laws and regulations
concerning controlled substances.
Volkman v. Drug Enf’t Admin., 567 F.3d
215, 223–24 (6th Cir. 2009) (citing
Gonzales v. Oregon, 546 U.S. 243, 272,
274 (2006)); Gaudio, 74 FR 10090–91.
In this case, Respondent dispensed
thousands of prescriptions without a
controlled substance license in violation
of both state and federal law. Although
there are not specific allegations
regarding the legitimacy of these
prescriptions, I find that dispensing
controlled substances without a license
constitutes negative dispensing
experience and weighs against
Respondent’s continued registration. In
fact, during one year, Respondent’s CDS
had lapsed for 9 months—the majority
of the year.
Regarding Factor Four, the
Government alleged that Respondent
repeatedly violated state and federal
laws related to controlled substances by
issuing thousands of prescriptions for
controlled substances in Louisiana
during periods when her Louisiana CDS
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license was expired. OSC, at 2–3 (citing
La. Stat. §§ 40:967(A)(1)(a) & 40:973; La.
Admin. Code tit. 46, §§ 2705 &
2707(B)(3)–(4); 21 U.S.C. 841(a)(1); 21
CFR 1306.03 & 1306.04). According to
Louisiana statute, ‘‘[e]very person who
conducts research with, manufactures,
distributes, procures, possesses,
prescribes, or dispenses any controlled
dangerous substance within this state
. . . shall obtain a controlled dangerous
substance license issued by the
Louisiana Board of Pharmacy in
accordance with the rules and
regulations promulgated by the board
prior to engaging in such activity.’’ La.
Stat. Ann. § 40:973(A)(1) (West 2021).
Moreover, Louisiana law states that ‘‘[a]
licensee shall not engage in any activity
requiring a valid CDS license while his
license is expired.’’ 4 La. Admin. Code
tit. 46, § 2707(B)(3) (2021). As for federal
law, ‘‘[a] prescription for a controlled
substance to be effective must be issued
for a legitimate medical purpose by an
individual practitioner acting in the
usual course of his professional
practice.’’ 21 CFR 1306.04(a). Further,
federal law defines an ‘‘individual
practitioner’’ as ‘‘a physician . . .
licensed, registered, or otherwise
permitted by . . . the jurisdiction in
which he/she practices, to dispense a
controlled substance in the course of
professional practice.’’ 21 CFR
1300.01(b). Additionally, federal law
states that ‘‘[a] prescription for a
controlled substance may be issued only
by an individual practitioner who is
. . . authorized to prescribe controlled
substances by the jurisdiction in which
he is licensed to practice his
profession.’’ 21 CFR 1306.03(a)(1).
Respondent issued thousands of
prescriptions for controlled substances
in Louisiana during three separate
periods when her Louisiana CDS license
was expired. Thus, I find that
Respondent violated both federal and
Louisiana state law related to controlled
substances. See Lisa Hamilton, N.P., 84
FR 71465, 71472 (2019) (finding that
prescriptions issued during the lapse of
the respondent’s Massachusetts
Controlled Substances Registration
violated state and federal law). In this
case, given the repeated and extensive
nature of Respondent’s violations of
federal and state law related to
4 The Government argues that under state law, the
period of expiration during which a Louisiana
practitioner cannot prescribe includes the 30 day
renewal window because the license has
technically expired. See RFAA, at 9. This position
is supported by the plain language of the statute
and the Louisiana Board of Pharmacy’s
memorandum to DEA, in which it included the
initial 30-day window in the listed periods of
expiration for Respondent’s CDS. See RFAAX G–2.
PO 00000
Frm 00074
Fmt 4703
Sfmt 4703
controlled substances, I find that Factors
Two and Four weigh against
Respondent such that I find
Respondent’s continued registration to
be inconsistent with the public interest
and, therefore, that a ground for
revocation exists under 21 U.S.C.
824(a)(4). Where, as here, the
Government has met its prima facie
burden of showing that a ground for
revocation exists, the burden shifts to
the Respondent to show why she can be
entrusted with a registration. See Jeffrey
Stein, M.D., 84 FR 46968, 46972 (2019).
III. Sanction
The Government has established
grounds to deny a registration; therefore,
I will review any evidence and
argument the Respondent submitted to
determine whether or not the
Respondent has presented ‘‘sufficient
mitigating evidence to assure the
Administrator that [she] can be trusted
with the responsibility carried by such
a registration.’’ Samuel S. Jackson,
D.D.S., 72 FR 23848, 23853 (2007)
(quoting Leo R. Miller, M.D., 53 FR
21931, 21932 (1988)). ‘‘‘Moreover,
because ‘‘past performance is the best
predictor of future performance,’’ ALRA
Labs, Inc. v. Drug Enf’t Admin., 54 F.3d
450, 452 (7th Cir. 1995), [the Agency]
has repeatedly held that where a
registrant has committed acts
inconsistent with the public interest, the
registrant must accept responsibility for
[the registrant’s] actions and
demonstrate that [registrant] will not
engage in future misconduct.’ ’’ Jayam
Krishna-Iyer, 74 FR 459, 463 (2009)
(quoting Medicine Shoppe, 73 FR 364,
387 (2008)); see also Samuel S. Jackson,
D.D.S., 72 FR 23853; John H. Kennnedy,
M.D., 71 FR 35705, 35709 (2006); Prince
George Daniels, D.D.S., 60 FR 62884,
62887 (1995). The issue of trust is
necessarily a fact-dependent
determination based on the
circumstances presented by the
individual respondent; therefore, the
Agency looks at factors, such as the
acceptance of responsibility and the
credibility of that acceptance as it
relates to the probability of repeat
violations or behavior and the nature of
the misconduct that forms the basis for
sanction, while also considering the
Agency’s interest in deterring similar
acts. See Arvinder Singh, M.D., 81 FR
8247, 8248 (2016).
A. Acceptance of Responsibility
As previously discussed, Respondent
effectively waived her right to a hearing
and therefore there is no credible
evidence on the record regarding
acceptance of responsibility for me to
consider. Even if I could consider the
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08DEN1
Federal Register / Vol. 86, No. 233 / Wednesday, December 8, 2021 / Notices
jspears on DSK121TN23PROD with NOTICES1
initial letter she submitted in response
to the OSC, it does not demonstrate
sufficient acceptance of responsibility or
remedial measures that would aid me in
entrusting Respondent with a
registration. See RFAAX B. In her letter,
Respondent offers some explanation as
to why she repeatedly failed to renew
her Louisiana CDS license in a timely
manner, and while the stressful
circumstances that she described
certainly garner sympathy, Respondent
did not unequivocally acknowledge her
own error in failing to keep track of the
status of her CDS license, which was
essential to her ability to lawfully
prescribe controlled substances. Id.
Respondent stated in her letter that
she had logged the expiration date for
her CDS license in multiple places, that
going forward, she would renew on the
date she receives the renewal letter, and
that she had already completed the most
recent renewal in July 2019. RFAAX B.
However, Respondent has not provided
any supporting documentation as to
these statements. The fact that she
repeatedly allowed this lapse to happen
year-after-year, does not demonstrate
confidence in her future compliance.
Moreover, Respondent’s errors regarding
the prehearing process—errors that
ultimately led to the termination of the
proceedings—do not inspire confidence
that she has improved upon the
underlying issue of responsibility
regarding her professional licensure.
B. Specific and General Deterrence
In addition to acceptance of
responsibility, the Agency considers
both specific and general deterrence
when determining an appropriate
sanction. Daniel A. Glick, D.D.S., 80 FR
74800, 74810 (2015). Specific deterrence
is the DEA’s interest in ensuring that a
registrant complies with the laws and
regulations governing controlled
substances in the future. Id. General
deterrence concerns the DEA’s
responsibility to deter conduct similar
to the proven allegations against the
respondent for the protection of the
public at large. Id. In this case, I believe
revocation of her DEA registration
would deter Respondent and the general
registrant community from ignoring the
serious state and federal requirements to
have specific licensure in order to be
entrusted with the responsibility of
issuing prescriptions for controlled
substances.
C. Egregiousness
The Agency also looks to the
egregiousness and the extent of the
misconduct as significant factors in
determining the appropriate sanction.
Garrett Howard Smith, M.D., 83 FR
VerDate Sep<11>2014
16:53 Dec 07, 2021
Jkt 256001
18910 (collecting cases). Although
Respondent’s actions in failing to renew
her CDS might seem minor or
transactional, the extent of the
misconduct was not. She issued
thousands of prescriptions for
controlled substances in Louisiana
during three separate periods when her
Louisiana CDS license was expired,
with these three separate periods
occurring successively and each ranging
from 4 to 9 months. The record evidence
demonstrates that Respondent had been
given timely notice via letter that her
license was terminated because she had
failed to renew it within 30 days after
its expiration date, and Respondent did
not provide any documentation or
explanation to support her claim that
she was not made aware until much
later. See RFAAX B and G–2–G–11.
Moreover, the multiple and successive
occurrences suggest that Respondent
did not take sufficient measures to
ensure that her mistake would not be
repeated.
As discussed above, to maintain a
registration when grounds for
revocation exist, a respondent must
convince the Administrator that her
acceptance of responsibility is
sufficiently credible to demonstrate that
the misconduct will not reoccur and
that she can be entrusted with a
registration. I find that Respondent has
not met this burden. Respondent has not
offered any credible evidence on the
record to rebut the Government’s case
for revocation. Further, Respondent’s
description of corrective measures was
unsupported by evidence, and given
Respondent’s subsequent errors
regarding the prehearing process,
Respondent has not demonstrated that
she can be trusted with the
responsibility of registration at this
time. Accordingly, I will order the
revocation of Respondent’s certificate of
registration.
Order
Pursuant to 28 CFR 0.100(b) and the
authority vested in me by 21 U.S.C.
824(a) and 21 U.S.C. 823(f), I hereby
revoke DEA Certificate of Registration
No. BM7946835 issued to Tamika Mayo,
M.D. Further, pursuant to 28 CFR
0.100(b) and the authority vested in me
by 21 U.S.C. 824(a) and 21 U.S.C. 823(f),
I hereby deny any pending application
of Tamika Mayo, M.D. to renew or
modify this registration, as well as any
other pending application of Tamika
PO 00000
Frm 00075
Fmt 4703
Sfmt 4703
69685
Mayo, M.D. for registration in Louisiana.
This Order is effective January 7, 2022.
Anne Milgram,
Administrator.
[FR Doc. 2021–26533 Filed 12–7–21; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Notice of Lodging of Proposed Third
Amendment To Consent Decree Under
the Clean Air Act
On December 2, 2021, the Department
of Justice lodged a proposed Third
Amendment to Consent Decree
(‘‘Amendment’’) with the United States
District Court for the Northern District
of Indiana in the lawsuit entitled United
States and the State of Indiana v. BP
Products North America Inc., Civil
Action No. 2:12–CV–207.
The Amendment relates to alleged
violations of a 2012 Consent Decree
(‘‘Decree’’) by BP Products North
America Inc., (‘‘BP Products’’) at its
refinery in Whiting, Indiana (‘‘Whiting
Refinery’’).
The Amendment will resolve BP
Products’ violations of particulate
matter (‘‘PM’’) limits contained in the
Decree and at 40 CFR part 60, subpart
Ja that are applicable to two fluidized
catalytic cracking units (‘‘FCCUs’’) at
the Whiting Refinery, and a motion to
enforce the Decree filed by several
Plaintiff-Intervenors.
The Amendment requires more
frequent PM testing, revised PM testing
parameters, operating parameters for
emissions and opacity monitors and for
electrostatic precipitators (‘‘ESPs’’), a
PM emissions control technology, and
the installation of various process
analyzers. BP Products will also
undertake a study to evaluate stack
testing and ESP operation during unit
startup and shutdown. BP Products will
pay $512,450 in stipulated penalties
after the Amendment is entered.
The publication of this notice opens
a period for public comment on the
Amendment. Comments should be
addressed to the Assistant Attorney
General, Environment and Natural
Resources Division, and should refer to
United States and the State of Indiana
v. BP Products North America Inc., D.J.
Ref. No. 90–5–2–1–09244. All
comments must be submitted no later
than thirty (30) days after the
publication date of this notice.
Comments may be submitted either by
email or by mail:
E:\FR\FM\08DEN1.SGM
08DEN1
Agencies
[Federal Register Volume 86, Number 233 (Wednesday, December 8, 2021)]
[Notices]
[Pages 69681-69685]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-26533]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Tamika Mayo, M.D.; Decision and Order
On July 23, 2019, the Assistant Administrator, Diversion Control
Division, Drug Enforcement Administration (hereinafter, DEA or
Government), issued an Order to Show Cause (hereinafter, OSC) to Tamika
Mayo, M.D. (hereinafter, Respondent), of Baton Rouge, Louisiana.
Request for Final Agency Action (hereinafter, RFAA), Exhibit
(hereinafter RFAAX) A (OSC), at 1 and 5. The OSC proposed to revoke
Respondent's DEA Certificate of Registration, Control No. BM7946835 and
to deny any pending applications for a new registration or for renewal
pursuant to 21 U.S.C. 824(a)(4) and 823(f), because Respondent had
``committed acts which render [her] registration inconsistent with the
public interest.'' Id. at 1.
The OSC alleged that Respondent had issued thousands of
prescriptions for controlled substances in Louisiana during periods
when her Louisiana Controlled Dangerous Substance (hereinafter, CDS)
license was expired. Id. at 2-3. Specifically, the OSC alleged that
between September 1, 2016, and January 17, 2017, Respondent issued over
1,850 prescriptions for controlled substances while her CDS license was
expired; between September 1, 2017, and June 13, 2018, Respondent
issued over 1,730 prescriptions for controlled substances while her CDS
license was expired; and between September 1, 2018, and February 15,
2019, Respondent issued over 400 prescriptions for controlled
substances while her CDS license was expired. Id. According to the OSC,
because Respondent was not authorized to issue prescriptions for
controlled substances during these periods, the prescriptions were
issued in violation of state and federal law. Id. at 3 (citing La.
Stat. Sec. Sec. 40:967(A)(1)(a) & 40:973; La. Admin. Code tit. 46,
Sec. Sec. 2705 & 2707(B)(3)-(4); 21 U.S.C. 841(a)(1); 21 CFR 1306.03 &
1306.04). The OSC concluded that ``[b]y issuing more than 3,900
prescriptions for controlled substances without state authorization,
and therefore in violation of state and federal law, [Respondent has]
committed such acts as would render [her] continued registration
inconsistent with the public interest.'' Id. (citing 21 U.S.C.
824(a)(4) & 823(f)(2) & (4)).
The OSC notified Respondent of the right to request a hearing on
the allegations or to submit a written statement, while waiving the
right to a hearing, the procedures for electing each option, and the
consequences for failing to elect either option. Id. at 4 (citing 21
CFR 1301.43). The OSC also notified Respondent of the opportunity to
submit a corrective action plan. Id. at 4-5 (citing 21 U.S.C.
824(c)(2)(C)).
By letter dated August 17, 2019, Respondent offered an explanation
in response to the allegations and stated that she was ``not waving
[sic] [her] right to a hearing.'' RFAAX B. On August 20, 2019,
Administrative Law Judge Mark M. Dowd (hereinafter, the ALJ) issued an
Order Directing Clarification, in which the ALJ instructed Respondent,
if she was seeking a hearing, to ``submit a document affirmatively and
unconditionally requesting a hearing'' and stated that if the new
document was timely filed, the initial filing would be deemed a timely
hearing request. RFAAX C, at 3. By email dated August 27, 2019,
Respondent requested a hearing. RFAAX D. On August 28, 2019, the ALJ
issued an Order for Prehearing Statements. RFAAX E, at 1. The
Government timely filed its prehearing statement on September 9, 2019.
Id. at 2. On September 30, 2019, the ALJ
[[Page 69682]]
issued an Order Terminating Proceedings, in which the ALJ found that
based on Respondent's failure to comply with the Order for Prehearing
Statements, ``Respondent has implicitly withdrawn her request for a
hearing'' and ordered the proceedings terminated. Id. at 4. The ALJ
noted that Respondent had contacted the Office of Administrative Law
Judges on September 20, 2019, and in response she had received:
Specific instructions on where to call if she had questions, an
additional copy of the Order for Prehearing Statements and an
additional request for Respondent to provide a phone number where she
could be reached for the conference, which she never provided. Id. at
2. On October 2, 2019, Respondent sent multiple emails to the Tribunal
offering an explanation and requesting that the proceedings be
reopened. ALJX 13-17. However, on October 2, 2019, the ALJ issued an
Order Denying Respondent's Request to Reopen These Proceedings, in
which the ALJ found that Respondent had not demonstrated sufficient
good cause to reopen the matter. RFAAX F, at 4. I have reviewed and
agree with the procedural rulings of the ALJ.
On March 30, 2020, the Government forwarded its RFAA, along with
the evidentiary record for this matter, to my office. Having considered
the record in its entirety, I find that the record established, by
substantial evidence, that Respondent committed acts that render her
continued registration inconsistent with the public interest.
Accordingly, I conclude that the appropriate sanction is to revoke
Respondent's DEA registration and to deny any pending applications for
renewal or new registration in Louisiana. I make the following findings
of fact.
I. Findings of Fact
A. Respondent's DEA Registration
Respondent is registered with the DEA as a practitioner authorized
to handle controlled substances in schedules II-V under DEA
registration number BM7946835 at 4336 North Blvd., Suite 101, Baton
Rouge, LA 70806. RFAAX G-1. Respondent filed a renewal of her DEA
registration ``on or about December 5, 2019.'' RFAAX G, at 1.\1\
---------------------------------------------------------------------------
\1\ It appears from Agency records that Respondent's
registration is in retired status, although it is unclear exactly
what precipitated that status. Regardless, the fact that a
registration has expired during the pendency of an OSC does not
impact my jurisdiction or prerogative under the Controlled
Substances Act (hereinafter, CSA) to adjudicate the OSC to finality.
Jeffrey D. Olsen, M.D., 84 FR 68474 (2019). Adjudicating this matter
to finality will create an official record the Agency can use in any
future interactions with Respondent. As additionally noted in Olsen,
``a final adjudication is a public record of the Agency's
expectations for current and prospective members of that
community,'' and adjudications inform stakeholders, such as
legislators and the public, about the Agency's work and allow them
to provide feedback to the Agency, thereby helping shape how the
Agency carries out its responsibilities under the CSA. Id.
Adjudicating this matter to finality will create a public record to
educate current and prospective registrants about the Agency's
expectations regarding the responsibilities of registrants under the
CSA and allow stakeholders to provide feedback regarding the
Agency's enforcement priorities and practices.
---------------------------------------------------------------------------
B. Government's Case
The Government's RFAA includes 18 attached exhibits consisting of
copies of hearing procedural documents and orders, a declaration from a
DEA Diversion Investigator (hereinafter, DI), a copy of Respondent's
DEA certificate of registration, various documents pertaining to the
status of Respondent's Louisiana CDS license, and various prescription
records from Respondent. See RFAAX A-G-11.
In a Declaration dated February 27, 2020, a DI assigned to the New
Orleans Field Division described the service of the OSC on Respondent
as well as the investigation activities involved in the current matter,
including the collection of the Government's exhibits. RFAAX G, at 1-4.
On November 3, 2016, the Louisiana Board of Pharmacy (hereinafter,
the Board) provided Respondent with a Termination Notice, notifying her
that her CDS license had been terminated because she had failed to
renew her license within 30 days after its expiration on September 1,
2016. RFAAX G-3. Respondent's CDS license remained in an expired status
until it was renewed, effective January 17, 2017. RFAAX G-2 (Expiration
Summary Memo from the Louisiana Board of Pharmacy, dated June 27,
2019).\2\ Nonetheless, from September 1, 2016, to January 17, 2017,
Respondent issued approximately 1,850 prescriptions for controlled
substances in the State of Louisiana. RFAAX G-6 and G-9.
---------------------------------------------------------------------------
\2\ According to the Expiration Summary Memo, the Board was only
able to verify periods of expiration after 2007 because prior to
2007, the CDS program was overseen by another agency. Id.
---------------------------------------------------------------------------
On November 3, 2017, the Board provided Respondent with a second
Termination Notice, notifying her that her CDS license had been
terminated, because she had failed to renew her license within 30 days
after its expiration on September 1, 2017. RFAAX G-4. Respondent's CDS
licensed remained in an expired status until it was renewed, effective
June 13, 2018. RFAAX G-2. Nonetheless, from September 1, 2017, to June
13, 2018, Respondent issued approximately 1,730 prescriptions for
controlled substances in the State of Louisiana. RFAAX G-7 and G-10.
On November 6, 2018, the Board provided Respondent with a third
Termination Notice, notifying her that her CDS license had been
terminated because she had failed to renew her license within 30 days
after its expiration on September 1, 2018. RFAAX G-5. Respondent's CDS
licensed remained in an expired status until it was renewed, effective
February 15, 2019. RFAAX G-2. Nonetheless, from September 1, 2018, to
February 15, 2019, Respondent issued approximately 400 prescriptions
for controlled substances in the State of Louisiana. RFAAX G-8 and G-
11.
II. Discussion
A. Government's Position
In its RFAA, the Government sought to revoke Respondent's DEA
registration and to deny any pending applications for renewal or
modification of Respondent's DEA registration because Respondent
``[had] committed acts which render her continued registration
inconsistent with the public interest, in violation of 21 U.S.C. 824(a)
and 823(f).'' RFAA, at 1. Specifically, the Government argued that
Respondent had repeatedly violated state and federal law by issuing
thousands of prescriptions for controlled substances while she lacked
the authority to do so due to the expiration of her Louisiana CDS
license. Id. at 7-11. The Government concluded its RFAA by requesting
that Respondent's DEA registration be revoked and that any pending
applications for modification or renewal of Respondent's DEA
registration be denied. Id. at 11.
B. Respondent's Position
The only statements from Respondent regarding the allegations
appear in the initial letter that Respondent submitted in response to
the OSC, which offers some explanation as to her misconduct, but offers
no supporting evidence or ability for me to assess the credibility of
her unsworn statements. See RFAAX B. In her letter, Respondent stated
that, as to the first period when she was issuing prescriptions while
her license was expired, she was under a lot of stress due to an
ongoing divorce and from working two jobs. Id. Respondent stated that
she did not know that her license was expired, and that ``when [she]
was notified in early 2017 that the license had expired, [she]
immediately got it renewed.'' Id. As to the second period
[[Page 69683]]
when she was issuing prescriptions while her license was expired,
Respondent stated that due to personal family issues, ``[she] wasn't
even thinking about the CDS license since [she] knew [she] had just
gotten it renewed in the early part of the year 2017.'' Id. Respondent
again stated that she did not realize her license was expired, and that
as soon as she was notified in early 2018 that the license was expired,
she immediately got it renewed. Id. Respondent did not offer an
explanation as to the third period when she was issuing prescriptions
while her license was expired. Id.
Respondent noted that she has practiced medicine in Louisiana for
20 years, she has never had a problem with her CDS license, her medical
license has never expired, and her DEA license has never expired. Id.
Respondent stated that her misconduct was unintentional and that
because ``[she] was commuting and not in the office every day, [she]
missed the renewal dates.'' Id. Respondent also noted that she was
``under horrible levels of stress'' and apologized for ``the license
having expired'', stating that it would ``never happen again.''
Respondent concluded her letter by describing corrective action that
she had taken, specifically that she had ``logged the expiration date
in several places, even on [her] personal cell phone'' and that she was
``renewing on the date that [she receives] the renewal letter.'' Id.
Respondent also stated that she had already completed the most recent
renewal in July 2019. Id. Finally, Respondent stated that she was ``not
waving [sic] [her] right to a hearing'' and that ``[i]f the DEA
wish[ed] to pursue [the matter] after [her] explanation, [she] still
would like to come to a hearing.'' Id.
As for Respondent's failure to comply with the Order for Prehearing
Statements that led to the termination of the proceedings without a
hearing, Respondent offered some explanation in her subsequent emails
to the Tribunal, in which she requested that the proceedings be
reopened. See ALJX 13-17. Specifically, Respondent stated that she did
not realize that she had to provide additional documents, noting that
she did not have a lawyer and was unfamiliar with the course of the
proceedings. ALJX 17.
I do not find this explanation regarding her noncompliance with the
proceedings to be persuasive. As the ALJ noted in the Order Denying
Respondent's Request to Reopen These Proceedings, the Respondent was
given clear instructions in the Order for Prehearing Statements to file
a Prehearing Statement, as well as the logistics and deadlines for
doing so. RFAAX F, at 2-3; see also ALJX 5. Further, ``the Respondent's
argument that she does not have a lawyer and is not familiar with these
proceedings does not provide sufficient cause for her failure to file a
Prehearing Statement.'' RFAAX F, at 3; see also ALJX 17. There was also
ample evidence that the instructions to provide a telephone number were
clear and that the date to file a prehearing statement was clear. See
ALJX 5, at 2-4. Respondent also was in receipt of the Government's
Prehearing Statement, so it would be difficult for her to credibly
argue ignorance as to what a prehearing statement was. See ALJX 6
(Email: Government's Pre-Hearing Statement).
Respondent's statements in her hearing request notably do not
refute the allegations in the OSC; therefore, I find that the facts in
the record remain uncontested.
C. Analysis
Under Section 304 of the CSA, ``[a] registration . . . to . . .
dispense a controlled substance . . . may be suspended or revoked by
the Attorney General upon a finding that the registrant . . . has
committed such acts that would render his [or her] registration under
section 823 of this title inconsistent with the public interest as
determined by such section.'' 21 U.S.C. 824(a)(4). In the case of a
``practitioner,'' defined in 21 U.S.C. 802(21) to include a
``physician,'' Congress directed the Attorney General to consider the
following factors in making the public interest determination:
(1) The recommendation of the appropriate State licensing board or
professional disciplinary authority.
(2) The applicant's experience in dispensing, or conducting
research with respect to 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. 21 U.S.C. 823(f).
The DEA considers these public interest factors in the disjunctive.
Robert A. Leslie, M.D., 68 FR 15227, 15230 (2003). Each factor is
weighed on a case-by-case basis. Morall v. Drug Enf't Admin., 412 F.3d
165, 173-74 (D.C. Cir. 2005). Any one factor, or combination of
factors, may be decisive. David H. Gillis, M.D., 58 FR 37507, 37508
(1993). Thus, there is no need to enter findings on each of the
factors. Hoxie v. Drug Enf't Admin., 419 F.3d 477, 482 (6th Cir. 2005).
Furthermore, there is no requirement to consider a factor in any given
level of detail. Trawick v. Drug Enf't Admin., 861 F.2d 72, 76-77 (4th
Cir. 1988). The balancing of the public interest factors ``is not a
contest in which score is kept; the Agency is not required to
mechanically count up the factors and determine how many favor the
Government and how many favor the registrant. Rather, it is an inquiry
which focuses on protecting the public interest. . . .'' Jayam Krishna-
Iyer, M.D., 74 FR 459, 462 (2009). When deciding whether registration
is in the public interest, the DEA must consider the totality of the
circumstances. See generally Joseph Gaudio, M.D., 74 FR 10083, 10094-95
(2009) (basing sanction on all evidence on record).
The Government has the burden of proving that the requirements for
revocation of a DEA registration in 21 U.S.C. 824(a) are satisfied. 21
CFR 1301.44(e). When the Government has met its prima facie case, the
burden then shifts to the Respondent to show that revoking registration
would not be appropriate, given the totality of the facts and
circumstances on the record. Med. Shoppe-Jonesborough, 73 FR 364, 387
(2008).
While I have considered all of the public interest factors,\3\ the
Government's case invoking the public interest factors of 21 U.S.C.
823(f) seeks revocation of Respondent's registration based solely under
Public Interest Factors Two and Four. I find that the Government's
evidence with respect to Factors Two and Four satisfies its prima
[[Page 69684]]
facie burden of showing that Respondent's continued registration would
be ``inconsistent with the public interest.'' 21 U.S.C. 824(a)(4).
Specifically, I find that the record contains substantial evidence that
Respondent violated both Louisiana state law and federal law when she
issued thousands of prescriptions for controlled substances in
Louisiana during periods when she lacked state authorization to do so.
I further find that Respondent failed to provide evidence to rebut the
Government's prima facie case.
---------------------------------------------------------------------------
\3\ As to Factor One, there is no evidence in the record of any
recommendation from Respondent's state licensing board or
professional disciplinary authority. 21 U.S.C. 823(f)(1). ``The fact
that the record contains no evidence of a recommendation by a state
licensing board does not weigh for or against a determination as to
whether continuation of Respondent's DEA certification is consistent
with the public interest.'' Roni Dreszer, M.D., 76 FR 19434, 19444
(2011).
As to Factor Three, there is no evidence in the record that
Respondent has been convicted of an offense under either federal or
state law ``relating to the manufacture, distribution, or dispensing
of controlled substances.'' 21 U.S.C. 823(f)(3). However, as Agency
cases have noted, there are a number of reasons why a person who has
engaged in criminal misconduct may never have been convicted of an
offense under this factor, let alone prosecuted for one. Dewey C.
MacKay, M.D., 75 FR 49956, 49973 (2010). Agency cases have therefore
found that ``the absence of such a conviction is of considerably
less consequence in the public interest inquiry'' and is therefore
not dispositive. Id.
As to Factor Five, the Government's allegations fit squarely
within the parameters of Factors Two and Four and do not raise
``other conduct which may threaten the public health and safety.''
21 U.S.C. 823(f)(5). Accordingly, Factor Five does not weigh for or
against Respondent.
---------------------------------------------------------------------------
1. Factors Two and Four
The DEA often analyzes Factors Two and Four together. See, e.g.,
Fred Samimi, M.D., 79 FR 18698, 18709 (2014); John V. Scalera, M.D., 78
FR 12092, 12098 (2013). Under Factor Two, the DEA analyzes a
registrant's ``experience in dispensing controlled substances.'' 21
U.S.C. 823(f)(2). Factor Two analysis focuses on a registrant's acts
that are inconsistent with the public interest, rather than on a
registrant's neutral or positive acts and experience. Randall L. Wolff,
M.D., 77 FR 5106, 5121 n.25 (2012) (explaining that ``every registrant
can undoubtedly point to an extensive body of legitimate prescribing
over the course of [the registrant's] professional career'' (quoting
Jayam Krishna-Iyer, M.D., 74 FR 459, 463 (2009))). Similarly, under
Factor Four, the DEA analyzes an applicant's compliance with federal
and state controlled substance laws. 21 U.S.C. 823(f)(4). The Factor
Four analysis focuses on violations of state and federal laws and
regulations concerning controlled substances. Volkman v. Drug Enf't
Admin., 567 F.3d 215, 223-24 (6th Cir. 2009) (citing Gonzales v.
Oregon, 546 U.S. 243, 272, 274 (2006)); Gaudio, 74 FR 10090-91.
In this case, Respondent dispensed thousands of prescriptions
without a controlled substance license in violation of both state and
federal law. Although there are not specific allegations regarding the
legitimacy of these prescriptions, I find that dispensing controlled
substances without a license constitutes negative dispensing experience
and weighs against Respondent's continued registration. In fact, during
one year, Respondent's CDS had lapsed for 9 months--the majority of the
year.
Regarding Factor Four, the Government alleged that Respondent
repeatedly violated state and federal laws related to controlled
substances by issuing thousands of prescriptions for controlled
substances in Louisiana during periods when her Louisiana CDS license
was expired. OSC, at 2-3 (citing La. Stat. Sec. Sec. 40:967(A)(1)(a) &
40:973; La. Admin. Code tit. 46, Sec. Sec. 2705 & 2707(B)(3)-(4); 21
U.S.C. 841(a)(1); 21 CFR 1306.03 & 1306.04). According to Louisiana
statute, ``[e]very person who conducts research with, manufactures,
distributes, procures, possesses, prescribes, or dispenses any
controlled dangerous substance within this state . . . shall obtain a
controlled dangerous substance license issued by the Louisiana Board of
Pharmacy in accordance with the rules and regulations promulgated by
the board prior to engaging in such activity.'' La. Stat. Ann. Sec.
40:973(A)(1) (West 2021). Moreover, Louisiana law states that ``[a]
licensee shall not engage in any activity requiring a valid CDS license
while his license is expired.'' \4\ La. Admin. Code tit. 46, Sec.
2707(B)(3) (2021). As for federal law, ``[a] prescription for a
controlled substance to be effective must be issued for a legitimate
medical purpose by an individual practitioner acting in the usual
course of his professional practice.'' 21 CFR 1306.04(a). Further,
federal law defines an ``individual practitioner'' as ``a physician . .
. licensed, registered, or otherwise permitted by . . . the
jurisdiction in which he/she practices, to dispense a controlled
substance in the course of professional practice.'' 21 CFR 1300.01(b).
Additionally, federal law states that ``[a] prescription for a
controlled substance may be issued only by an individual practitioner
who is . . . authorized to prescribe controlled substances by the
jurisdiction in which he is licensed to practice his profession.'' 21
CFR 1306.03(a)(1).
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\4\ The Government argues that under state law, the period of
expiration during which a Louisiana practitioner cannot prescribe
includes the 30 day renewal window because the license has
technically expired. See RFAA, at 9. This position is supported by
the plain language of the statute and the Louisiana Board of
Pharmacy's memorandum to DEA, in which it included the initial 30-
day window in the listed periods of expiration for Respondent's CDS.
See RFAAX G-2.
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Respondent issued thousands of prescriptions for controlled
substances in Louisiana during three separate periods when her
Louisiana CDS license was expired. Thus, I find that Respondent
violated both federal and Louisiana state law related to controlled
substances. See Lisa Hamilton, N.P., 84 FR 71465, 71472 (2019) (finding
that prescriptions issued during the lapse of the respondent's
Massachusetts Controlled Substances Registration violated state and
federal law). In this case, given the repeated and extensive nature of
Respondent's violations of federal and state law related to controlled
substances, I find that Factors Two and Four weigh against Respondent
such that I find Respondent's continued registration to be inconsistent
with the public interest and, therefore, that a ground for revocation
exists under 21 U.S.C. 824(a)(4). Where, as here, the Government has
met its prima facie burden of showing that a ground for revocation
exists, the burden shifts to the Respondent to show why she can be
entrusted with a registration. See Jeffrey Stein, M.D., 84 FR 46968,
46972 (2019).
III. Sanction
The Government has established grounds to deny a registration;
therefore, I will review any evidence and argument the Respondent
submitted to determine whether or not the Respondent has presented
``sufficient mitigating evidence to assure the Administrator that [she]
can be trusted with the responsibility carried by such a
registration.'' Samuel S. Jackson, D.D.S., 72 FR 23848, 23853 (2007)
(quoting Leo R. Miller, M.D., 53 FR 21931, 21932 (1988)). ```Moreover,
because ``past performance is the best predictor of future
performance,'' ALRA Labs, Inc. v. Drug Enf't Admin., 54 F.3d 450, 452
(7th Cir. 1995), [the Agency] has repeatedly held that where a
registrant has committed acts inconsistent with the public interest,
the registrant must accept responsibility for [the registrant's]
actions and demonstrate that [registrant] will not engage in future
misconduct.' '' Jayam Krishna-Iyer, 74 FR 459, 463 (2009) (quoting
Medicine Shoppe, 73 FR 364, 387 (2008)); see also Samuel S. Jackson,
D.D.S., 72 FR 23853; John H. Kennnedy, M.D., 71 FR 35705, 35709 (2006);
Prince George Daniels, D.D.S., 60 FR 62884, 62887 (1995). The issue of
trust is necessarily a fact-dependent determination based on the
circumstances presented by the individual respondent; therefore, the
Agency looks at factors, such as the acceptance of responsibility and
the credibility of that acceptance as it relates to the probability of
repeat violations or behavior and the nature of the misconduct that
forms the basis for sanction, while also considering the Agency's
interest in deterring similar acts. See Arvinder Singh, M.D., 81 FR
8247, 8248 (2016).
A. Acceptance of Responsibility
As previously discussed, Respondent effectively waived her right to
a hearing and therefore there is no credible evidence on the record
regarding acceptance of responsibility for me to consider. Even if I
could consider the
[[Page 69685]]
initial letter she submitted in response to the OSC, it does not
demonstrate sufficient acceptance of responsibility or remedial
measures that would aid me in entrusting Respondent with a
registration. See RFAAX B. In her letter, Respondent offers some
explanation as to why she repeatedly failed to renew her Louisiana CDS
license in a timely manner, and while the stressful circumstances that
she described certainly garner sympathy, Respondent did not
unequivocally acknowledge her own error in failing to keep track of the
status of her CDS license, which was essential to her ability to
lawfully prescribe controlled substances. Id.
Respondent stated in her letter that she had logged the expiration
date for her CDS license in multiple places, that going forward, she
would renew on the date she receives the renewal letter, and that she
had already completed the most recent renewal in July 2019. RFAAX B.
However, Respondent has not provided any supporting documentation as to
these statements. The fact that she repeatedly allowed this lapse to
happen year-after-year, does not demonstrate confidence in her future
compliance. Moreover, Respondent's errors regarding the prehearing
process--errors that ultimately led to the termination of the
proceedings--do not inspire confidence that she has improved upon the
underlying issue of responsibility regarding her professional
licensure.
B. Specific and General Deterrence
In addition to acceptance of responsibility, the Agency considers
both specific and general deterrence when determining an appropriate
sanction. Daniel A. Glick, D.D.S., 80 FR 74800, 74810 (2015). Specific
deterrence is the DEA's interest in ensuring that a registrant complies
with the laws and regulations governing controlled substances in the
future. Id. General deterrence concerns the DEA's responsibility to
deter conduct similar to the proven allegations against the respondent
for the protection of the public at large. Id. In this case, I believe
revocation of her DEA registration would deter Respondent and the
general registrant community from ignoring the serious state and
federal requirements to have specific licensure in order to be
entrusted with the responsibility of issuing prescriptions for
controlled substances.
C. Egregiousness
The Agency also looks to the egregiousness and the extent of the
misconduct as significant factors in determining the appropriate
sanction. Garrett Howard Smith, M.D., 83 FR 18910 (collecting cases).
Although Respondent's actions in failing to renew her CDS might seem
minor or transactional, the extent of the misconduct was not. She
issued thousands of prescriptions for controlled substances in
Louisiana during three separate periods when her Louisiana CDS license
was expired, with these three separate periods occurring successively
and each ranging from 4 to 9 months. The record evidence demonstrates
that Respondent had been given timely notice via letter that her
license was terminated because she had failed to renew it within 30
days after its expiration date, and Respondent did not provide any
documentation or explanation to support her claim that she was not made
aware until much later. See RFAAX B and G-2-G-11. Moreover, the
multiple and successive occurrences suggest that Respondent did not
take sufficient measures to ensure that her mistake would not be
repeated.
As discussed above, to maintain a registration when grounds for
revocation exist, a respondent must convince the Administrator that her
acceptance of responsibility is sufficiently credible to demonstrate
that the misconduct will not reoccur and that she can be entrusted with
a registration. I find that Respondent has not met this burden.
Respondent has not offered any credible evidence on the record to rebut
the Government's case for revocation. Further, Respondent's description
of corrective measures was unsupported by evidence, and given
Respondent's subsequent errors regarding the prehearing process,
Respondent has not demonstrated that she can be trusted with the
responsibility of registration at this time. Accordingly, I will order
the revocation of Respondent's certificate of registration.
Order
Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21
U.S.C. 824(a) and 21 U.S.C. 823(f), I hereby revoke DEA Certificate of
Registration No. BM7946835 issued to Tamika Mayo, M.D. Further,
pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 U.S.C.
824(a) and 21 U.S.C. 823(f), I hereby deny any pending application of
Tamika Mayo, M.D. to renew or modify this registration, as well as any
other pending application of Tamika Mayo, M.D. for registration in
Louisiana. This Order is effective January 7, 2022.
Anne Milgram,
Administrator.
[FR Doc. 2021-26533 Filed 12-7-21; 8:45 am]
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