David Mwebe, M.D.; Decision and Order, 51065-51068 [2020-18082]
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Federal Register / Vol. 85, No. 161 / Wednesday, August 19, 2020 / Notices
sanction less than revocation would
send a message to the regulated
community that compliance with the
law is not a condition precedent to
maintaining registration.
A balancing of the statutory public
interest factors, coupled with
consideration of Respondent
Pharmacy’s failure to accept
responsibility, the absence of any
evidence of remedial measures to guard
against recurrence, and the Agency’s
interest in deterrence, supports the
conclusion that Respondent Pharmacy
should not continue to be entrusted
with a registration. Accordingly, I shall
order the sanctions the Government
requested, as contained in the Order
below.
V. ORDER
Pursuant to 28 CFR 0.100(b) and the
authority vested in me by 21 U.S.C.
824(a), I hereby revoke DEA Certificate
of Registration FM3950070 issued to
Morning Star Pharmacy & Medical
Supply 1. Further, pursuant to 28 CFR
0.100(b) and the authority vested in me
by 21 U.S.C. 823(f), I hereby deny any
pending application of Morning Star
Pharmacy & Medical Supply 1 to renew
or modify this registration. This order is
effective September 18, 2020.
Timothy J. Shea,
Acting Administrator.
[FR Doc. 2020–18083 Filed 8–18–20; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
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David Mwebe, M.D.; Decision and
Order
On August 17, 2018, a former Acting
Administrator of the Drug Enforcement
Administration (hereinafter, DEA or
Government) issued an Order to Show
Cause and Immediate Suspension of
Registration to David Mwebe, M.D.
(hereinafter, Registrant). Government’s
Request for Final Agency Action Exhibit
(hereinafter, RFAAX) 2, at 1 (Order to
Show Cause and Immediate Suspension
Order (hereinafter, collectively OSC)).
The OSC informed Registrant of the
immediate suspension of his DEA
Certificate of Registration BM9925388
pursuant to 21 U.S.C. 824(d), ‘‘because
[his] continued registration constitute[d]
an imminent danger to the public health
and safety.’’ Id.
The substantive ground for the
proceeding, as alleged in the OSC, is
that Registrant’s ‘‘continued registration
is inconsistent with the public interest,
as that term is defined in 21 U.S.C.
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823(f).’’ Id. Specifically, the OSC alleges
that Registrant issued at least 42
fraudulent prescriptions for controlled
substances, either to himself using
various aliases, or to other individuals,
which Registrant filled himself in
violation of 21 U.S.C. 843(a)(3), 21 CFR
1306.04(a), and Nebraska law. Id. at 2
(citing Neb. Rev. St. § 28–418(1)(c) (It is
unlawful to ‘‘acquire or obtain or to
attempt to acquire or obtain possession
of a controlled substance by theft,
misrepresentation, fraud, forgery,
deception, or subterfuge.’’)).
In issuing the OSC, which
immediately suspended the registration,
the former Acting Administrator
concluded that Registrant’s ‘‘continued
registration is inconsistent with the
public interest’’ based on a preliminary
finding that Registrant ‘‘issued
prescriptions for controlled substances
that [Registrant] knew were without a
legitimate medical purpose and were
outside the course of professional
practice’’ and that were ‘‘indicative of
[Registrant’s] general illegitimate
practice of prescribing controlled
substances in violation of State and
Federal laws.’’ Id. at 7. Citing 21 U.S.C.
824(d), he also made the preliminary
finding that Registrant’s ‘‘continued
registration during the pendency of the
proceedings would constitute an
imminent danger to the public health or
safety because of the substantial
likelihood that [Registrant] will
continue to unlawfully prescribe
controlled substances, thereby allowing
the diversion of controlled substances
unless [Registrant’s] DEA COR is
suspended.’’ Id. The former Acting
Administrator authorized the DEA
Special Agents and Diversion
Investigators serving the OSC on
Registrant to place under seal or remove
for safekeeping all controlled substances
Registrant possessed pursuant to the
immediately suspended registration. Id.
(citing 21 U.S.C. 824(f) and 21 CFR
1301.36(f)). The former Acting
Administrator also directed those DEA
employees to take possession of
Registrant’s Certificate of Registration
BM9925388 1 and any unused
prescription forms. Id.
According to the Declaration of a DEA
Special Agent from the Philadelphia
Field Division, the DEA Special Agent
personally served the OSC on Registrant
on August 17, 2018. RFAAX 3
(Declaration of Special Agent A). A DEA
Diversion Investigator also stated that
1 The OSC identified Registrant’s DEA registration
number as BW9925388. RFAAX, at 1. The
Government has stated that this was a scrivener’s
error, and the correct number for Registrant’s DEA
registration, which the Government seeks to revoke,
is BM9925388. RFAA, at 2 n.1.
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Registrant called her on August 17,
2018, regarding questions he had about
the OSC he had received. RFAAX 4, at
2 (Declaration of DEA Diversion
Investigator). Based on the Special
Agent’s Declaration, the Diversion
Investigator’s Declaration, and my
review of the record, I find that the
Government accomplished service of
the OSC on Registrant on August 17,
2018.
On April 23, 2019, the Government
forwarded a Request for Final Agency
Action, along with the evidentiary
record for this matter, to my office.2 The
OSC notified Registrant of his right to
request a hearing on the allegations or
to submit a written statement while
waiving his right to a hearing, the
procedures for electing each option, and
the consequences for failing to elect
either option. Id. at 7–8 (citing 21 CFR
1301.43(c)). I find that more than thirty
days have now passed since the
Government accomplished service of
the OSC. I further find, based on the
Government’s written representations,
that neither Registrant, nor anyone
purporting to represent the Registrant,
requested a hearing, or submitted a
written statement while waiving
Registrant’s right to a hearing.
Accordingly, I find that Registrant has
waived the right to a hearing and the
right to submit a written statement. 21
CFR 1301.43(d). I, therefore, issue this
Decision and Order based on the record
submitted by the Government, which
constitutes the entire record before me.
21 CFR 1301.43(e).
Having considered the record in its
entirety, I find that the record
establishes, by substantial evidence, that
Registrant committed acts rendering his
continued registration inconsistent with
the public interest. I also find that
Registrant has submitted no evidence
that he accepts responsibility for his
failures to meet the responsibilities of a
registrant nor presented any evidence of
mitigation or remedial measures.
Accordingly, I conclude that the
appropriate sanctions are (1) for
Registrant’s DEA registration to be
revoked; and (2) for any pending
application by Registrant to be denied.
Based on the representations of the
Government in its RFAA, I make the
following findings of fact.
2 In the RFAA, the Government alleged that, in
addition to the allegations in the OSC, Registrant
lacks ‘‘authority to handle controlled substances in
the state of Nebraska, the state where he is
registered with the DEA.’’ RFAA at 1. I find it
unnecessary to address this allegation as I have
found that Registrant’s registration should be
revoked based on the allegations from the OSC.
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I. Findings of Fact
A. Registrant’s DEA Registration
Registrant is registered with the DEA
as a practitioner in schedules II through
V under DEA Certificate of Registration
No. BM9925388, at 106 East Wayne
Street, P.O. Box 8, Randolph, NE 68771.
RFAAX 1 (Registrant’s Certificate of
Registration). This registration expires
on January 31, 2021. Id. The registration
was suspended pursuant to the
Immediate Suspension Order dated
August 17, 2018. OSC, at 7.
B. The Investigation of Registrant
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DEA investigators began an
investigation into Registrant in July
2017 after receiving information that
Registrant was selling prescriptions for
oxycodone and hydrocodone at a
gentleman’s club. RFAAX 5 (Declaration
of Special Agent B), at 1.
On November 6, 2017, the Nebraska
State Patrol (hereinafter, NSP) notified a
DEA Special Agent (hereinafter, Special
Agent B) that the Norfolk (Nebraska)
Police Department (hereinafter, NPD)
was summoned to a pharmacy in
Norfolk, Nebraska (hereinafter,
Pharmacy A) regarding a fraudulent
prescription. Id. A man had attempted
to fill a prescription for Adderall 3 using
a driver’s license bearing the name
‘‘Joshua Masembe.’’ Id. The NPD
informed Special Agent B that they had
run a check of the driver’s license
number for ‘‘Joshua Masembe’’ and
discovered that it was associated with
Registrant’s name, David Mwebe;
Registrant’s date of birth; and
Registrant’s home address.4 Id. at 1–2.
NPD also informed Special Agent B that
Pharmacy A’s records showed that
‘‘Joshua Masembe’’ had also filled a
prescription for Adderall in July 2017.
Id. at 2. Special Agent B obtained from
NSP copies of the two Adderall
prescriptions issued to ‘‘Joshua
Masembe.’’ Id., App. A. The
prescriptions were issued by Registrant.
Id.
3 Amphetamine mixture products, which are
schedule II controlled substances pursuant to 21
CFR 1308.12(d)(1), are marketed under the brand
name ‘‘Adderall,’’ and methylphenidate, a schedule
II controlled substance pursuant to 21 CFR
1308.12(d)(4), is marketed under the brand name
‘‘Ritalin.’’ RFAA, at 3 (citing National Drug Code
Directory, available at https://
www.accessdata.fda.gov/scripts/cder/ndc/
index.cfm).
4 The Government included the license number,
date of birth, and address listed on the driver’s
license for ‘‘Joshua Masembe.’’ I am not listing that
information publicly in this Decision, because they
match Registrant’s actual license number, date of
birth, and home address.
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1. Interviews With Registrant
On May 30, 2018, Special Agent B, an
investigator from the Nebraska Health
Department, and an NSP investigator
(hereinafter, the Investigators)
interviewed Registrant at his DEA
registered address. Id. at 2. The
interview was recorded. Id. During the
interview, Registrant admitted, inter
alia, that he had written fraudulent
prescriptions, RFAAX 4, App. A
(transcript of recorded interview), at 72;
taken Adderall that Registrant
prescribed to ‘‘Joshua Masembe’’ and
lied to DEA investigators about doing
so, id. at 57, 66–67; filled
antihypertension, Adderall, and Ritalin
prescriptions that were written for
‘‘Peter Senteza,’’ id. at 55–56; and stolen
prescriptions because he could not fill
the prescriptions on a monthly basis by
himself, id. at 68. Registrant told the
investigators that he sent his driver’s
license to ‘‘Peter Senteza’’ to be altered,
so he could pick up prescriptions
written for Registrant’s aliases. Id. at 57–
59. Registrant stated that ‘‘Peter
Senteza’’ altered Registrant’s driver’s
license to create fake driver’s licenses by
swapping Registrant’s name with the
aliases’ name. Id. Registrant told the
investigators that ‘‘Peter Senteza’’ lived
in Pittsburgh. Id. at 57.
Later in the interview, Registrant
invited the Investigators to his
residence. RFAAX 5, at 2. At his
residence, Registrant gave the
Investigators three altered Nebraska
driver’s licenses. Id. Two of the licenses
bore the name ‘‘Sam Kajubi.’’ Id. One of
these licenses was expired. Id. The third
license bore the name ‘‘Joshua
Masembe.’’ Id. at 3. All three licenses
had Registrant’s actual license number,
date of birth, and home address. Id. at
2–3. They also contained Registrant’s
picture and identical physical
descriptors. Id. at 3; see RFAAX 5,
Appxs. C and D (copies of the three
altered Nebraska driver’s licenses).
Registrant also provided the
Investigators with a box of empty
prescription bottles. RFAAX 5, at 3. The
box contained two bottles of alprazolam
and two bottles of methylphenidate in
the name of ‘‘Peter Senteza,’’ and three
bottles of alprazolam, two bottles of
methylphenidate, and one bottle of
Adderall in the name of ‘‘Sam Kajubi.’’
Id.; RFAAX 5, Appxs. E and F (copies
of photographs of the empty bottles).
The labels on the bottles listed
Registrant as the prescriber. RFAAX 5,
Appxs. E and F.
On June 6, 2018, DEA Special Agent
B and the Diversion Investigator met
with Registrant at the Nebraska State
Patrol Troop B Headquarters. RFAAX 4,
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at 2. According to the Diversion
Investigator, Registrant stated that ‘‘he
used Ritalin and Adderall to help him
work through long hours’’ and ‘‘used
alprazolam to take ‘power naps’ during
his long shifts.’’ Id. The Diversion
Investigator asked Registrant to
voluntarily surrender his DEA
Registration. Id. Registrant declined. Id.
2. Administrative Subpoenas
On June 15, 2018, DEA served
administrative subpoenas on U-Save
Pharmacy in Norfolk, Nebraska
(hereinafter, U-Save Norfolk) and USave Pharmacy in Wayne, Nebraska
(hereinafter, U-Save Wayne). RFAAX 5,
at 3. The U-Save Norfolk administrative
subpoena sought information on ‘‘Peter
Senteza,’’ including a patient summary
of all prescriptions prescribed to ‘‘Peter
Senteza.’’ Id. at App. G. The U-Save
Wayne administrative subpoena sought
information on ‘‘Sam Kajubi,’’ including
a patient summary of all prescriptions
prescribed to ‘‘Sam Kajubi.’’ Id. at App.
H.
U-Save Norfolk provided DEA with
copies of sixteen prescriptions for
controlled substances issued by
Registrant to ‘‘Peter Senteza’’ and a
patient profile for ‘‘Peter Senteza’’ in
response to the administrative
subpoena. Id. at Appxs. I and K. The USave Norfolk records show that
Registrant issued, at a minimum, the
following prescriptions to ‘‘Peter
Senteza:’’ (1) Two prescriptions for 30
dosage units of Adderall 30 mg; (2) six
prescriptions for 60 dosage units of
methylphenidate 20 mg; and (3) eight
prescriptions for 60 dosage units of
alprazolam 1mg.5 Id at App. I. The
prescription labels U-Save Norfolk
provided for the ‘‘Peter Senteza’’
prescriptions listed Registrant’s home
address in Osmond, Nebraska,6 id. at 1,
2, 8, 15, 16, and U-Save Norfolk’s
patient profile for ‘‘Peter Senteza’’ also
lists Registrant’s home address in
Osmond, Nebraska, id. at App. K.
U-Save Wayne provided DEA with
copies of twenty-four prescriptions for
controlled substances issued by
Registrant to ‘‘Sam Kajubi’’ and a
patient profile for ‘‘Sam Kajubi’’ in
response to the administrative
subpoena. Id. at Appxs. J and L. The USave Wayne records show that
Registrant issued, at a minimum, the
following twenty-four prescriptions for
controlled substances to ‘‘Sam Kajubi:’’
(1) Three prescriptions for 60 dosage
units of Adderall 30 mg; (2) nine
5 Alprazolam is a schedule IV controlled
substance pursuant to 21 CFR 1308.14(c)(2).
6 Registrant did not write an address for ‘‘Peter
Senteza’’ on the hard copies of the prescriptions.
RFAAX 5, App. I.
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prescriptions for 60 dosage units of
methylphenidate 20 mg; (3) one
prescription for 30 dosage units of
methylphenidate 20 mg; and (4) eleven
prescriptions for 60 dosage units of
alprazolam 1 mg. Id. at App. J. U-Save
Wayne’s patient profile for ‘‘Sam
Kajubi’’ lists Registrant’s home address
in Osmond, Nebraska and the same date
of birth as Registrant.7 Id. at App. L.
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C. The Government’s Allegations
The Government has alleged that on
at least forty-two occasions, between
July 10, 2014 and March 8, 2018,
Registrant ‘‘issued fraudulent
prescriptions for controlled substances
to either [him]self using various aliases,
or to other individuals which
[Registrant] filled.’’ OSC, at 2.
Specifically, the Government alleged
that Registrant issued prescriptions for
controlled substances that ‘‘were not for
a legitimate medical purpose and that
were not issued in the usual course of
professional practice because
[Registrant] issued these prescriptions to
[him]self under various aliases,
including Sam Kajubi and Joshua
Masembe; and impersonated Peter
Senteza.’’ Id.
As discussed above, the pharmacy
records from U-Save Wayne, U-Save
Norfolk, and Pharmacy A show that
Registrant issued at least forty-two
prescriptions for controlled substances
to ‘‘Sam Kajubi,’’ ‘‘Joshua Masembe,’’
and ‘‘Peter Senteza.’’ The U-Save patient
profiles for ‘‘Sam Kajubi’’ and ‘‘Peter
Senteza’’ list Registrant’s home address
in Osmond, Nebraska, 8 and the person
filling the controlled substance
prescriptions for ‘‘Joshua Masembe’’ at
Pharmacy A used an altered driver’s
license bearing Registrant’s license
number, home address, and date of
birth.
Registrant admitted to the
Investigators that he filled prescriptions
that he wrote for controlled substances
under the names ‘‘Joshua Masembe’’
and ‘‘Peter Senteza.’’ He told the
Investigators that he sent his driver’s
license to ‘‘Peter Senteza’’ to be altered
so that Registrant could fill
prescriptions that he wrote for his
aliases. Registrant provided three of
these altered licenses in the names of
‘‘Joshua Masembe’’ and ‘‘Sam Kajubi’’ to
the Investigators. Registrant also had
empty prescription bottles for Adderall,
7 Registrant only wrote an address for ‘‘Sam
Kajubi’’ on one of the twenty-four prescriptions USave Wayne produced to the Agency. Registrant
wrote his own home address as ‘‘Sam Kajubi’s’’
address on the prescription. RFAAX 5, at App. J,
at 6.
8 Registrant told the Investigators that ‘‘Peter
Senteza’’ lived in Pittsburgh.
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alprazolam, and methylphenidate in the
names of ‘‘Sam Kajubi’’ and ‘‘Peter
Senteza’’ in his home. Registrant further
admitted that he wrote fraudulent
prescriptions, stole prescriptions
because he could not fill the
prescriptions on a monthly basis by
himself, and used methylphenidate and
Adderall to help him work and
alprazolam to take ‘‘power naps’’ during
his work shifts.
Based on the documentary evidence
and Registrant’s own admissions, I find
that the Government has proven by
substantial evidence that Registrant
issued and filled controlled substance
prescriptions under the aliases of ‘‘Sam
Kajubi’’ and ‘‘Joshua Masembe’’ for
personal use and that he issued and
filled prescriptions using the name
‘‘Peter Senteza’’ for his personal use.
II. Discussion
Under the Controlled Substances Act
(CSA), ‘‘[a] registration . . . to . . .
distribute[ ] or dispense a controlled
substance . . . may be suspended or
revoked by the Attorney General upon
a finding that the registrant . . . has
committed such acts as would render
his registration under section 823 of this
title inconsistent with the public
interest as determined under such
section.’’ 21 U.S.C. 824(a)(4). In the case
of a ‘‘practitioner,’’ which is 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 [registrant]’s experience in
dispensing . . . controlled substances.
(3) The [registrant]’s conviction record
under Federal or State laws relating to
the . . . 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). These factors are
considered in the disjunctive. Robert A.
Leslie, M.D., 68 FR 15,227, 15,230
(2003).
According to Agency decisions, I
‘‘may rely on any one or a combination
of factors and may give each factor the
weight [I] deem[ ] appropriate in
determining whether’’ to revoke a
registration. Id.; see also Jones Total
Health Care Pharm., LLC v. Drug Enf’t
Admin., 881 F.3d 823, 830 (11th Cir.
2018) (citing Akhtar-Zaidi v. Drug Enf’t
Admin., 841 F.3d 707, 711 (6th Cir.
2016); MacKay v. Drug Enf’t Admin.,
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664 F.3d 808, 816 (10th Cir. 2011);
Volkman v. Drug Enf’t Admin., 567 F.3d
215, 222 (6th Cir. 2009); Hoxie v. Drug
Enf’t Admin., 419 F.3d 477, 482 (6th Cir.
2005). Moreover, while I am required to
consider each of the factors, I ‘‘need not
make explicit findings as to each one.’’
MacKay, 664 F.3d at 816 (quoting
Volkman, 567 F.3d at 222); see also
Hoxie, 419 F.3d at 482. ‘‘In short, . . .
the Agency is not required to
mechanically count up the factors and
determine how many favor the
Government and how many favor the
registrant. Rather, it is an inquiry which
focuses on protecting the public
interest; what matters is the seriousness
of the registrant’s misconduct.’’ Jayam
Krishna-Iyer, M.D., 74 FR 459, 462
(2009). Accordingly, findings under a
single factor can support the revocation
of a registration. MacKay, 664 F.3d at
821.
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).
In this matter, while I have
considered all of the Factors, the
Government’s evidence in support of its
prima facie case is confined to Factors
Two and Four.9 I find the Government
has satisfied its prima facie burden of
showing that Registrant’s continued
registration would be ‘‘inconsistent with
the public interest.’’ 21 U.S.C. 824(a)(4).
9 In the RFAA, the Government alleged and
provided evidence that the state of Nebraska has
revoked Registrant’s medical license. RFAA at 1, 9–
10, 14–15; RFAAX 4, at Appxs. B and C. I am not
considering this evidence under Factor One,
because the Government did not notice the issue in
the OSC, and I find it unnecessary to reach because
Factors Two and Four demonstrate strongly that
Registrant’s continued registration would be
inconsistent with the public interest.
As to Factor Three, there is no evidence in the
record that Registrant has a ‘‘conviction record
under Federal or State laws 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
49,956, 49,973 (2010). Agency cases have therefore
held that ‘‘the absence of such a conviction is of
considerably less consequence in the public interest
inquiry’’ and is therefore not dispositive. Id.
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A. Factors Two and/or Four—The
Registrant’s Experience in Dispensing
Controlled Substances and Compliance
With Applicable Laws Related to
Controlled Substances
The Government has alleged that
Registrant violated federal and state
laws related to controlled substances
when, ‘‘on forty-two occasions,
[Registrant] issued fraudulent
prescriptions for controlled substances
to himself by using various aliases, or to
other individuals that he filled himself.’’
RFAA, at 11–14.
Under the CSA, ‘‘[i]t shall be unlawful
for any person knowingly or
intentionally to acquire or obtain
possession of a controlled substance by
misrepresentation, fraud, forgery,
deception, or subterfuge.’’ 21 U.S.C.
843(a)(3). Similarly, under Nebraska
state law, it is unlawful ‘‘to acquire or
obtain or to attempt to acquire or obtain
possession of a controlled substance by
theft, misrepresentation, fraud, forgery,
deception, or subterfuge.’’ Neb. Rev.
Stat. § 28–418(1)(c)(2016). I find that the
Government has established based on
uncontroverted evidence that by
knowingly issuing controlled substance
prescriptions to aliases and other
individuals that he filled himself using
fraudulent identification documents
Registrant violated 21 U.S.C. 843(a)(3)
and Neb. Rev. Stat. § 28–418(1)(c).
I also find that the record establishes
by substantial evidence that Registrant
violated 21 CFR 1306.04(a). Under
§ 1306.04, a lawful prescription for
controlled substances is one that is
‘‘issued for a legitimate medical purpose
by an individual practitioner acting in
the usual course of his professional
practice.’’ 21 CFR 1306.04(a). A
practitioner must establish and maintain
a legitimate doctor-patient relationship
in order to act ‘‘in the usual course of
. . . professional practice’’ and to issue
a prescription for a ‘‘legitimate medical
purpose’’ under the CSA. Ralph J.
Chambers, 79 FR 4962, 4970 (2014)
(citing Paul H. Volkman, 73 FR 30,629,
30,642 (2008), pet. for rev. denied
Volkman v. Drug Enf’t Admin., 567 F.3d
215, 223–24 (6th Cir. 2009)); see also
U.S. v. Moore, 423 U.S. 122, 142–43
(1975) (noting that evidence established
that the physician exceeded the bounds
of professional practice, when ‘‘he gave
inadequate physical examinations or
none at all,’’ ‘‘ignored the results of the
tests he did make,’’ and ‘‘took no
precautions against . . . misuse and
diversion’’). Agency decisions have
demonstrated that in order for a
physician to utilize his registration to
dispense controlled substances, there
must be a ‘‘valid physician-patient
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relationship’’ and that ‘‘[l]egally, there is
absolutely no difference between the
sale of an illicit drug on the street and
the illicit dispensing of a licit drug by
means of a physician’s prescription.’’
Mario Avello, M.D. 70 FR 11,695, 11,697
(2005) (citing Mark Wade, M.D., 69 FR
7018 (2004) and Floyd A. Santner, M.D.,
55 FR 37,581 (1990)). Registrant clearly
issued the subject fraudulent
prescriptions for controlled substances
absent a valid physician-patient
relationship and thereby violated 21
CFR 1306.04(a).
B. Registrant’s Registration is
Inconsistent With the Public Interest
and Presented an Imminent Danger
The Agency has previously found that
practitioners’ registrations were
inconsistent with the public interest in
matters where the practitioners had
issued fraudulent prescriptions for
themselves. See, e.g., David W. Bailey,
M.D., 81 FR 6045, 6047 (2016) (revoking
registration of physician who issued
controlled prescriptions in his wife’s
name for personal use); Ronald Phillips,
D.O., 61 FR 15,304, 15,305 (1996)
(revoking registration of practitioner
who admitted to prescribing controlled
substances in the names of family and
friends, filling the prescriptions himself
at pharmacies, and personally using a
large portion of the controlled
substances); John V. Scalera, 78 FR
12,092, 12,098 (2013) (denying
application of practitioner who issued
controlled substance prescriptions in a
deceased relative’s name for personal
use). Accordingly, I find that the
evidence in this matter establishes
Registrant ‘‘has committed such acts as
would render his registration . . .
inconsistent with the public interest.’’
See 21 U.S.C. 824(a)(4).
For purposes of the imminent danger
inquiry, my findings also lead to the
conclusion that Registrant has ‘‘fail[ed]
. . . to maintain effective controls
against diversion or otherwise comply
with the obligations of a registrant’’
under the CSA. 21 U.S.C. 824(d)(2). The
substantial evidence that Registrant was
issuing and filling fraudulent
prescriptions for controlled substances
for his personal use also establishes that
there was ‘‘a substantial likelihood [that
an] . . . abuse of a controlled substance
. . . [would] occur in the absence of the
immediate suspension’’ of Registrant’s
registration. Id.
III. Sanction
Where, as here, the Government has
met its prima facie burden of showing
that a Registrant’s continued registration
is inconsistent with the public interest,
the burden shifts to the Registrant to
PO 00000
Frm 00062
Fmt 4703
Sfmt 4703
show why he can be entrusted with a
registration. Garrett Howard Smith,
M.D., 83 FR 18,882, 18,910 (2018)
(collecting cases). Registrant did not
present any evidence of remorse for his
past misconduct or evidence of
rehabilitative actions taken to correct
his past unlawful behavior. Further, he
provided no assurances that he would
not engage in such conduct in the
future. Absent such evidence and such
assurances in this matter, I find that
continued registration of Registrant is
inconsistent with the public interest.
Registrant’s silence weighs against his
continued registration. Zvi H. Perper,
M.D., 77 FR 64,131, 64,142 (2012 (citing
Med. Shoppe-Jonesborough, 73 FR at
387); see also Samuel S. Jackson, 72 FR
23,848, 23,853 (2007). Accordingly, I
find that the factors weigh in favor of
sanction and I shall order the sanctions
the Government requested, as contained
in the Order below.
IV. Order
Pursuant to 28 CFR 0.100(b) and the
authority vested in me by 21 U.S.C.
823(f) and 824(a), I hereby revoke DEA
Certificate of Registration BM9925388
issued to David Mwebe, M.D. I further
hereby deny any pending application of
David Mwebe, M.D., to renew or modify
this registration. This Order is effective
September 18, 2020.
Timothy J. Shea,
Acting Administrator.
[FR Doc. 2020–18082 Filed 8–18–20; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Notice of Lodging of Proposed
Consent Judgment Under the Clean Air
Act
On August 13, 2020, the Department
of Justice lodged a proposed consent
judgment with the United States District
Court for the Eastern District of New
York in the lawsuit entitled United
States of America v. Village of Rockville
Centre, New York, Case No. 20–CV–
3663.
The United States filed this lawsuit to
seek civil penalties and injunctive relief
for violations of the Clean Air Act, 42
U.S.C. 7401 et seq. (‘‘CAA’’). The
alleged violations stem from the Village
of Rockville Centre’s (‘‘Village’’) failure
to comply with federally-enforceable
emissions limits for particulate matter
(‘‘PM’’) and nitrogen oxide (‘‘NOX’’).
The Village operates a 33 megawatt
municipal power plant (the ‘‘Power
Plant’’) that provides electric power to
its residents, in part, using diesel
engines. The Village operates the Power
E:\FR\FM\19AUN1.SGM
19AUN1
Agencies
[Federal Register Volume 85, Number 161 (Wednesday, August 19, 2020)]
[Notices]
[Pages 51065-51068]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-18082]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
David Mwebe, M.D.; Decision and Order
On August 17, 2018, a former Acting Administrator of the Drug
Enforcement Administration (hereinafter, DEA or Government) issued an
Order to Show Cause and Immediate Suspension of Registration to David
Mwebe, M.D. (hereinafter, Registrant). Government's Request for Final
Agency Action Exhibit (hereinafter, RFAAX) 2, at 1 (Order to Show Cause
and Immediate Suspension Order (hereinafter, collectively OSC)). The
OSC informed Registrant of the immediate suspension of his DEA
Certificate of Registration BM9925388 pursuant to 21 U.S.C. 824(d),
``because [his] continued registration constitute[d] an imminent danger
to the public health and safety.'' Id.
The substantive ground for the proceeding, as alleged in the OSC,
is that Registrant's ``continued registration is inconsistent with the
public interest, as that term is defined in 21 U.S.C. 823(f).'' Id.
Specifically, the OSC alleges that Registrant issued at least 42
fraudulent prescriptions for controlled substances, either to himself
using various aliases, or to other individuals, which Registrant filled
himself in violation of 21 U.S.C. 843(a)(3), 21 CFR 1306.04(a), and
Nebraska law. Id. at 2 (citing Neb. Rev. St. Sec. 28-418(1)(c) (It is
unlawful to ``acquire or obtain or to attempt to acquire or obtain
possession of a controlled substance by theft, misrepresentation,
fraud, forgery, deception, or subterfuge.'')).
In issuing the OSC, which immediately suspended the registration,
the former Acting Administrator concluded that Registrant's ``continued
registration is inconsistent with the public interest'' based on a
preliminary finding that Registrant ``issued prescriptions for
controlled substances that [Registrant] knew were without a legitimate
medical purpose and were outside the course of professional practice''
and that were ``indicative of [Registrant's] general illegitimate
practice of prescribing controlled substances in violation of State and
Federal laws.'' Id. at 7. Citing 21 U.S.C. 824(d), he also made the
preliminary finding that Registrant's ``continued registration during
the pendency of the proceedings would constitute an imminent danger to
the public health or safety because of the substantial likelihood that
[Registrant] will continue to unlawfully prescribe controlled
substances, thereby allowing the diversion of controlled substances
unless [Registrant's] DEA COR is suspended.'' Id. The former Acting
Administrator authorized the DEA Special Agents and Diversion
Investigators serving the OSC on Registrant to place under seal or
remove for safekeeping all controlled substances Registrant possessed
pursuant to the immediately suspended registration. Id. (citing 21
U.S.C. 824(f) and 21 CFR 1301.36(f)). The former Acting Administrator
also directed those DEA employees to take possession of Registrant's
Certificate of Registration BM9925388 \1\ and any unused prescription
forms. Id.
---------------------------------------------------------------------------
\1\ The OSC identified Registrant's DEA registration number as
BW9925388. RFAAX, at 1. The Government has stated that this was a
scrivener's error, and the correct number for Registrant's DEA
registration, which the Government seeks to revoke, is BM9925388.
RFAA, at 2 n.1.
---------------------------------------------------------------------------
According to the Declaration of a DEA Special Agent from the
Philadelphia Field Division, the DEA Special Agent personally served
the OSC on Registrant on August 17, 2018. RFAAX 3 (Declaration of
Special Agent A). A DEA Diversion Investigator also stated that
Registrant called her on August 17, 2018, regarding questions he had
about the OSC he had received. RFAAX 4, at 2 (Declaration of DEA
Diversion Investigator). Based on the Special Agent's Declaration, the
Diversion Investigator's Declaration, and my review of the record, I
find that the Government accomplished service of the OSC on Registrant
on August 17, 2018.
On April 23, 2019, the Government forwarded a Request for Final
Agency Action, along with the evidentiary record for this matter, to my
office.\2\ The OSC notified Registrant of his right to request a
hearing on the allegations or to submit a written statement while
waiving his right to a hearing, the procedures for electing each
option, and the consequences for failing to elect either option. Id. at
7-8 (citing 21 CFR 1301.43(c)). I find that more than thirty days have
now passed since the Government accomplished service of the OSC. I
further find, based on the Government's written representations, that
neither Registrant, nor anyone purporting to represent the Registrant,
requested a hearing, or submitted a written statement while waiving
Registrant's right to a hearing. Accordingly, I find that Registrant
has waived the right to a hearing and the right to submit a written
statement. 21 CFR 1301.43(d). I, therefore, issue this Decision and
Order based on the record submitted by the Government, which
constitutes the entire record before me. 21 CFR 1301.43(e).
---------------------------------------------------------------------------
\2\ In the RFAA, the Government alleged that, in addition to the
allegations in the OSC, Registrant lacks ``authority to handle
controlled substances in the state of Nebraska, the state where he
is registered with the DEA.'' RFAA at 1. I find it unnecessary to
address this allegation as I have found that Registrant's
registration should be revoked based on the allegations from the
OSC.
---------------------------------------------------------------------------
Having considered the record in its entirety, I find that the
record establishes, by substantial evidence, that Registrant committed
acts rendering his continued registration inconsistent with the public
interest. I also find that Registrant has submitted no evidence that he
accepts responsibility for his failures to meet the responsibilities of
a registrant nor presented any evidence of mitigation or remedial
measures. Accordingly, I conclude that the appropriate sanctions are
(1) for Registrant's DEA registration to be revoked; and (2) for any
pending application by Registrant to be denied.
Based on the representations of the Government in its RFAA, I make
the following findings of fact.
[[Page 51066]]
I. Findings of Fact
A. Registrant's DEA Registration
Registrant is registered with the DEA as a practitioner in
schedules II through V under DEA Certificate of Registration No.
BM9925388, at 106 East Wayne Street, P.O. Box 8, Randolph, NE 68771.
RFAAX 1 (Registrant's Certificate of Registration). This registration
expires on January 31, 2021. Id. The registration was suspended
pursuant to the Immediate Suspension Order dated August 17, 2018. OSC,
at 7.
B. The Investigation of Registrant
DEA investigators began an investigation into Registrant in July
2017 after receiving information that Registrant was selling
prescriptions for oxycodone and hydrocodone at a gentleman's club.
RFAAX 5 (Declaration of Special Agent B), at 1.
On November 6, 2017, the Nebraska State Patrol (hereinafter, NSP)
notified a DEA Special Agent (hereinafter, Special Agent B) that the
Norfolk (Nebraska) Police Department (hereinafter, NPD) was summoned to
a pharmacy in Norfolk, Nebraska (hereinafter, Pharmacy A) regarding a
fraudulent prescription. Id. A man had attempted to fill a prescription
for Adderall \3\ using a driver's license bearing the name ``Joshua
Masembe.'' Id. The NPD informed Special Agent B that they had run a
check of the driver's license number for ``Joshua Masembe'' and
discovered that it was associated with Registrant's name, David Mwebe;
Registrant's date of birth; and Registrant's home address.\4\ Id. at 1-
2. NPD also informed Special Agent B that Pharmacy A's records showed
that ``Joshua Masembe'' had also filled a prescription for Adderall in
July 2017. Id. at 2. Special Agent B obtained from NSP copies of the
two Adderall prescriptions issued to ``Joshua Masembe.'' Id., App. A.
The prescriptions were issued by Registrant. Id.
---------------------------------------------------------------------------
\3\ Amphetamine mixture products, which are schedule II
controlled substances pursuant to 21 CFR 1308.12(d)(1), are marketed
under the brand name ``Adderall,'' and methylphenidate, a schedule
II controlled substance pursuant to 21 CFR 1308.12(d)(4), is
marketed under the brand name ``Ritalin.'' RFAA, at 3 (citing
National Drug Code Directory, available at https://www.accessdata.fda.gov/scripts/cder/ndc/index.cfm).
\4\ The Government included the license number, date of birth,
and address listed on the driver's license for ``Joshua Masembe.'' I
am not listing that information publicly in this Decision, because
they match Registrant's actual license number, date of birth, and
home address.
---------------------------------------------------------------------------
1. Interviews With Registrant
On May 30, 2018, Special Agent B, an investigator from the Nebraska
Health Department, and an NSP investigator (hereinafter, the
Investigators) interviewed Registrant at his DEA registered address.
Id. at 2. The interview was recorded. Id. During the interview,
Registrant admitted, inter alia, that he had written fraudulent
prescriptions, RFAAX 4, App. A (transcript of recorded interview), at
72; taken Adderall that Registrant prescribed to ``Joshua Masembe'' and
lied to DEA investigators about doing so, id. at 57, 66-67; filled
antihypertension, Adderall, and Ritalin prescriptions that were written
for ``Peter Senteza,'' id. at 55-56; and stolen prescriptions because
he could not fill the prescriptions on a monthly basis by himself, id.
at 68. Registrant told the investigators that he sent his driver's
license to ``Peter Senteza'' to be altered, so he could pick up
prescriptions written for Registrant's aliases. Id. at 57-59.
Registrant stated that ``Peter Senteza'' altered Registrant's driver's
license to create fake driver's licenses by swapping Registrant's name
with the aliases' name. Id. Registrant told the investigators that
``Peter Senteza'' lived in Pittsburgh. Id. at 57.
Later in the interview, Registrant invited the Investigators to his
residence. RFAAX 5, at 2. At his residence, Registrant gave the
Investigators three altered Nebraska driver's licenses. Id. Two of the
licenses bore the name ``Sam Kajubi.'' Id. One of these licenses was
expired. Id. The third license bore the name ``Joshua Masembe.'' Id. at
3. All three licenses had Registrant's actual license number, date of
birth, and home address. Id. at 2-3. They also contained Registrant's
picture and identical physical descriptors. Id. at 3; see RFAAX 5,
Appxs. C and D (copies of the three altered Nebraska driver's
licenses).
Registrant also provided the Investigators with a box of empty
prescription bottles. RFAAX 5, at 3. The box contained two bottles of
alprazolam and two bottles of methylphenidate in the name of ``Peter
Senteza,'' and three bottles of alprazolam, two bottles of
methylphenidate, and one bottle of Adderall in the name of ``Sam
Kajubi.'' Id.; RFAAX 5, Appxs. E and F (copies of photographs of the
empty bottles). The labels on the bottles listed Registrant as the
prescriber. RFAAX 5, Appxs. E and F.
On June 6, 2018, DEA Special Agent B and the Diversion Investigator
met with Registrant at the Nebraska State Patrol Troop B Headquarters.
RFAAX 4, at 2. According to the Diversion Investigator, Registrant
stated that ``he used Ritalin and Adderall to help him work through
long hours'' and ``used alprazolam to take `power naps' during his long
shifts.'' Id. The Diversion Investigator asked Registrant to
voluntarily surrender his DEA Registration. Id. Registrant declined.
Id.
2. Administrative Subpoenas
On June 15, 2018, DEA served administrative subpoenas on U-Save
Pharmacy in Norfolk, Nebraska (hereinafter, U-Save Norfolk) and U-Save
Pharmacy in Wayne, Nebraska (hereinafter, U-Save Wayne). RFAAX 5, at 3.
The U-Save Norfolk administrative subpoena sought information on
``Peter Senteza,'' including a patient summary of all prescriptions
prescribed to ``Peter Senteza.'' Id. at App. G. The U-Save Wayne
administrative subpoena sought information on ``Sam Kajubi,'' including
a patient summary of all prescriptions prescribed to ``Sam Kajubi.''
Id. at App. H.
U-Save Norfolk provided DEA with copies of sixteen prescriptions
for controlled substances issued by Registrant to ``Peter Senteza'' and
a patient profile for ``Peter Senteza'' in response to the
administrative subpoena. Id. at Appxs. I and K. The U-Save Norfolk
records show that Registrant issued, at a minimum, the following
prescriptions to ``Peter Senteza:'' (1) Two prescriptions for 30 dosage
units of Adderall 30 mg; (2) six prescriptions for 60 dosage units of
methylphenidate 20 mg; and (3) eight prescriptions for 60 dosage units
of alprazolam 1mg.\5\ Id at App. I. The prescription labels U-Save
Norfolk provided for the ``Peter Senteza'' prescriptions listed
Registrant's home address in Osmond, Nebraska,\6\ id. at 1, 2, 8, 15,
16, and U-Save Norfolk's patient profile for ``Peter Senteza'' also
lists Registrant's home address in Osmond, Nebraska, id. at App. K.
---------------------------------------------------------------------------
\5\ Alprazolam is a schedule IV controlled substance pursuant to
21 CFR 1308.14(c)(2).
\6\ Registrant did not write an address for ``Peter Senteza'' on
the hard copies of the prescriptions. RFAAX 5, App. I.
---------------------------------------------------------------------------
U-Save Wayne provided DEA with copies of twenty-four prescriptions
for controlled substances issued by Registrant to ``Sam Kajubi'' and a
patient profile for ``Sam Kajubi'' in response to the administrative
subpoena. Id. at Appxs. J and L. The U-Save Wayne records show that
Registrant issued, at a minimum, the following twenty-four
prescriptions for controlled substances to ``Sam Kajubi:'' (1) Three
prescriptions for 60 dosage units of Adderall 30 mg; (2) nine
[[Page 51067]]
prescriptions for 60 dosage units of methylphenidate 20 mg; (3) one
prescription for 30 dosage units of methylphenidate 20 mg; and (4)
eleven prescriptions for 60 dosage units of alprazolam 1 mg. Id. at
App. J. U-Save Wayne's patient profile for ``Sam Kajubi'' lists
Registrant's home address in Osmond, Nebraska and the same date of
birth as Registrant.\7\ Id. at App. L.
---------------------------------------------------------------------------
\7\ Registrant only wrote an address for ``Sam Kajubi'' on one
of the twenty-four prescriptions U-Save Wayne produced to the
Agency. Registrant wrote his own home address as ``Sam Kajubi's''
address on the prescription. RFAAX 5, at App. J, at 6.
---------------------------------------------------------------------------
C. The Government's Allegations
The Government has alleged that on at least forty-two occasions,
between July 10, 2014 and March 8, 2018, Registrant ``issued fraudulent
prescriptions for controlled substances to either [him]self using
various aliases, or to other individuals which [Registrant] filled.''
OSC, at 2. Specifically, the Government alleged that Registrant issued
prescriptions for controlled substances that ``were not for a
legitimate medical purpose and that were not issued in the usual course
of professional practice because [Registrant] issued these
prescriptions to [him]self under various aliases, including Sam Kajubi
and Joshua Masembe; and impersonated Peter Senteza.'' Id.
As discussed above, the pharmacy records from U-Save Wayne, U-Save
Norfolk, and Pharmacy A show that Registrant issued at least forty-two
prescriptions for controlled substances to ``Sam Kajubi,'' ``Joshua
Masembe,'' and ``Peter Senteza.'' The U-Save patient profiles for ``Sam
Kajubi'' and ``Peter Senteza'' list Registrant's home address in
Osmond, Nebraska, \8\ and the person filling the controlled substance
prescriptions for ``Joshua Masembe'' at Pharmacy A used an altered
driver's license bearing Registrant's license number, home address, and
date of birth.
---------------------------------------------------------------------------
\8\ Registrant told the Investigators that ``Peter Senteza''
lived in Pittsburgh.
---------------------------------------------------------------------------
Registrant admitted to the Investigators that he filled
prescriptions that he wrote for controlled substances under the names
``Joshua Masembe'' and ``Peter Senteza.'' He told the Investigators
that he sent his driver's license to ``Peter Senteza'' to be altered so
that Registrant could fill prescriptions that he wrote for his aliases.
Registrant provided three of these altered licenses in the names of
``Joshua Masembe'' and ``Sam Kajubi'' to the Investigators. Registrant
also had empty prescription bottles for Adderall, alprazolam, and
methylphenidate in the names of ``Sam Kajubi'' and ``Peter Senteza'' in
his home. Registrant further admitted that he wrote fraudulent
prescriptions, stole prescriptions because he could not fill the
prescriptions on a monthly basis by himself, and used methylphenidate
and Adderall to help him work and alprazolam to take ``power naps''
during his work shifts.
Based on the documentary evidence and Registrant's own admissions,
I find that the Government has proven by substantial evidence that
Registrant issued and filled controlled substance prescriptions under
the aliases of ``Sam Kajubi'' and ``Joshua Masembe'' for personal use
and that he issued and filled prescriptions using the name ``Peter
Senteza'' for his personal use.
II. Discussion
Under the Controlled Substances Act (CSA), ``[a] registration . . .
to . . . distribute[ ] or dispense a controlled substance . . . may be
suspended or revoked by the Attorney General upon a finding that the
registrant . . . has committed such acts as would render his
registration under section 823 of this title inconsistent with the
public interest as determined under such section.'' 21 U.S.C.
824(a)(4). In the case of a ``practitioner,'' which is 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 [registrant]'s experience in dispensing . . . controlled
substances.
(3) The [registrant]'s conviction record under Federal or State
laws relating to the . . . 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). These factors are considered in the disjunctive.
Robert A. Leslie, M.D., 68 FR 15,227, 15,230 (2003).
According to Agency decisions, I ``may rely on any one or a
combination of factors and may give each factor the weight [I] deem[ ]
appropriate in determining whether'' to revoke a registration. Id.; see
also Jones Total Health Care Pharm., LLC v. Drug Enf't Admin., 881 F.3d
823, 830 (11th Cir. 2018) (citing Akhtar-Zaidi v. Drug Enf't Admin.,
841 F.3d 707, 711 (6th Cir. 2016); MacKay v. Drug Enf't Admin., 664
F.3d 808, 816 (10th Cir. 2011); Volkman v. Drug Enf't Admin., 567 F.3d
215, 222 (6th Cir. 2009); Hoxie v. Drug Enf't Admin., 419 F.3d 477, 482
(6th Cir. 2005). Moreover, while I am required to consider each of the
factors, I ``need not make explicit findings as to each one.'' MacKay,
664 F.3d at 816 (quoting Volkman, 567 F.3d at 222); see also Hoxie, 419
F.3d at 482. ``In short, . . . the Agency is not required to
mechanically count up the factors and determine how many favor the
Government and how many favor the registrant. Rather, it is an inquiry
which focuses on protecting the public interest; what matters is the
seriousness of the registrant's misconduct.'' Jayam Krishna-Iyer, M.D.,
74 FR 459, 462 (2009). Accordingly, findings under a single factor can
support the revocation of a registration. MacKay, 664 F.3d at 821.
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).
In this matter, while I have considered all of the Factors, the
Government's evidence in support of its prima facie case is confined to
Factors Two and Four.\9\ I find the Government has satisfied its prima
facie burden of showing that Registrant's continued registration would
be ``inconsistent with the public interest.'' 21 U.S.C. 824(a)(4).
---------------------------------------------------------------------------
\9\ In the RFAA, the Government alleged and provided evidence
that the state of Nebraska has revoked Registrant's medical license.
RFAA at 1, 9-10, 14-15; RFAAX 4, at Appxs. B and C. I am not
considering this evidence under Factor One, because the Government
did not notice the issue in the OSC, and I find it unnecessary to
reach because Factors Two and Four demonstrate strongly that
Registrant's continued registration would be inconsistent with the
public interest.
As to Factor Three, there is no evidence in the record that
Registrant has a ``conviction record under Federal or State laws
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 49,956, 49,973 (2010). Agency cases have
therefore held that ``the absence of such a conviction is of
considerably less consequence in the public interest inquiry'' and
is therefore not dispositive. Id.
---------------------------------------------------------------------------
[[Page 51068]]
A. Factors Two and/or Four--The Registrant's Experience in Dispensing
Controlled Substances and Compliance With Applicable Laws Related to
Controlled Substances
The Government has alleged that Registrant violated federal and
state laws related to controlled substances when, ``on forty-two
occasions, [Registrant] issued fraudulent prescriptions for controlled
substances to himself by using various aliases, or to other individuals
that he filled himself.'' RFAA, at 11-14.
Under the CSA, ``[i]t shall be unlawful for any person knowingly or
intentionally to acquire or obtain possession of a controlled substance
by misrepresentation, fraud, forgery, deception, or subterfuge.'' 21
U.S.C. 843(a)(3). Similarly, under Nebraska state law, it is unlawful
``to acquire or obtain or to attempt to acquire or obtain possession of
a controlled substance by theft, misrepresentation, fraud, forgery,
deception, or subterfuge.'' Neb. Rev. Stat. Sec. 28-418(1)(c)(2016). I
find that the Government has established based on uncontroverted
evidence that by knowingly issuing controlled substance prescriptions
to aliases and other individuals that he filled himself using
fraudulent identification documents Registrant violated 21 U.S.C.
843(a)(3) and Neb. Rev. Stat. Sec. 28-418(1)(c).
I also find that the record establishes by substantial evidence
that Registrant violated 21 CFR 1306.04(a). Under Sec. 1306.04, a
lawful prescription for controlled substances is one that is ``issued
for a legitimate medical purpose by an individual practitioner acting
in the usual course of his professional practice.'' 21 CFR 1306.04(a).
A practitioner must establish and maintain a legitimate doctor-patient
relationship in order to act ``in the usual course of . . .
professional practice'' and to issue a prescription for a ``legitimate
medical purpose'' under the CSA. Ralph J. Chambers, 79 FR 4962, 4970
(2014) (citing Paul H. Volkman, 73 FR 30,629, 30,642 (2008), pet. for
rev. denied Volkman v. Drug Enf't Admin., 567 F.3d 215, 223-24 (6th
Cir. 2009)); see also U.S. v. Moore, 423 U.S. 122, 142-43 (1975)
(noting that evidence established that the physician exceeded the
bounds of professional practice, when ``he gave inadequate physical
examinations or none at all,'' ``ignored the results of the tests he
did make,'' and ``took no precautions against . . . misuse and
diversion''). Agency decisions have demonstrated that in order for a
physician to utilize his registration to dispense controlled
substances, there must be a ``valid physician-patient relationship''
and that ``[l]egally, there is absolutely no difference between the
sale of an illicit drug on the street and the illicit dispensing of a
licit drug by means of a physician's prescription.'' Mario Avello, M.D.
70 FR 11,695, 11,697 (2005) (citing Mark Wade, M.D., 69 FR 7018 (2004)
and Floyd A. Santner, M.D., 55 FR 37,581 (1990)). Registrant clearly
issued the subject fraudulent prescriptions for controlled substances
absent a valid physician-patient relationship and thereby violated 21
CFR 1306.04(a).
B. Registrant's Registration is Inconsistent With the Public Interest
and Presented an Imminent Danger
The Agency has previously found that practitioners' registrations
were inconsistent with the public interest in matters where the
practitioners had issued fraudulent prescriptions for themselves. See,
e.g., David W. Bailey, M.D., 81 FR 6045, 6047 (2016) (revoking
registration of physician who issued controlled prescriptions in his
wife's name for personal use); Ronald Phillips, D.O., 61 FR 15,304,
15,305 (1996) (revoking registration of practitioner who admitted to
prescribing controlled substances in the names of family and friends,
filling the prescriptions himself at pharmacies, and personally using a
large portion of the controlled substances); John V. Scalera, 78 FR
12,092, 12,098 (2013) (denying application of practitioner who issued
controlled substance prescriptions in a deceased relative's name for
personal use). Accordingly, I find that the evidence in this matter
establishes Registrant ``has committed such acts as would render his
registration . . . inconsistent with the public interest.'' See 21
U.S.C. 824(a)(4).
For purposes of the imminent danger inquiry, my findings also lead
to the conclusion that Registrant has ``fail[ed] . . . to maintain
effective controls against diversion or otherwise comply with the
obligations of a registrant'' under the CSA. 21 U.S.C. 824(d)(2). The
substantial evidence that Registrant was issuing and filling fraudulent
prescriptions for controlled substances for his personal use also
establishes that there was ``a substantial likelihood [that an] . . .
abuse of a controlled substance . . . [would] occur in the absence of
the immediate suspension'' of Registrant's registration. Id.
III. Sanction
Where, as here, the Government has met its prima facie burden of
showing that a Registrant's continued registration is inconsistent with
the public interest, the burden shifts to the Registrant to show why he
can be entrusted with a registration. Garrett Howard Smith, M.D., 83 FR
18,882, 18,910 (2018) (collecting cases). Registrant did not present
any evidence of remorse for his past misconduct or evidence of
rehabilitative actions taken to correct his past unlawful behavior.
Further, he provided no assurances that he would not engage in such
conduct in the future. Absent such evidence and such assurances in this
matter, I find that continued registration of Registrant is
inconsistent with the public interest. Registrant's silence weighs
against his continued registration. Zvi H. Perper, M.D., 77 FR 64,131,
64,142 (2012 (citing Med. Shoppe-Jonesborough, 73 FR at 387); see also
Samuel S. Jackson, 72 FR 23,848, 23,853 (2007). Accordingly, I find
that the factors weigh in favor of sanction and I shall order the
sanctions the Government requested, as contained in the Order below.
IV. Order
Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21
U.S.C. 823(f) and 824(a), I hereby revoke DEA Certificate of
Registration BM9925388 issued to David Mwebe, M.D. I further hereby
deny any pending application of David Mwebe, M.D., to renew or modify
this registration. This Order is effective September 18, 2020.
Timothy J. Shea,
Acting Administrator.
[FR Doc. 2020-18082 Filed 8-18-20; 8:45 am]
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