Aaron Gloskowski, D.O.; Decision and Order, 66969-66972 [2011-28011]
Download as PDF
Federal Register / Vol. 76, No. 209 / Friday, October 28, 2011 / Notices
contained in the Order to Show Cause.
See 21 CFR 1301.46; 1316.49. I make the
following findings of fact.
Findings
Respondent previously held a DEA
registration as a practitioner. However,
on September 19, 2005, Respondent was
issued an Order to Show Cause and
Immediate Suspension of Registration
based on allegations that he had issued
controlled-substance prescriptions over
the internet to persons he neither saw
nor physically examined and with
whom ‘‘he had no prior doctor-patient
relationship,’’ and on whom he did not
maintain patient records. GX 3, at 5. The
2005 Show Cause Order thus alleged
that Respondent acted outside of the
usual course of professional practice
and lacked a legitimate medical purpose
in issuing the prescriptions. Id. at 6–7.
Thereafter, Respondent and DEA
settled the matter by entering into a
Memorandum of Agreement (MOA),
which became effective on July 11,
2006, and which is to remain in effect
for five years. GX 4, at 8. Pursuant to the
MOA, Respondent agreed to surrender
his registration and the Government
agreed that it would approve his
application for a new registration ‘‘after
the expiration of twenty-four (24)
months from service of the’’ 2005 Show
Cause Order ‘‘barring any unforeseen or
heretofore unknown basis to deny the
application,’’ and that ‘‘no act that
formed the basis for * * * paragraphs
15–17’’ of the 2005 Show Cause Order
‘‘shall form the sole basis for [the]
denial of Registration.’’ 1 Id. at 4–5. On
August 21, 2006, Respondent
surrendered his registration. GX 5.
On May 2, 2007, a Federal grand jury
sitting in the District of Puerto Rico,
issued a superseding indictment, which
charged Respondent with conspiring to
distribute controlled substances, in
violation of 21 U.S.C. 846; unlawfully
distributing a controlled substance
(hydrocodone), in violation of 21 U.S.C.
841(a)(1); conspiracy to commit wire
fraud, in violation of 18 U.S.C. 1349;
and conspiracy to commit money
laundering, in violation of 18 U.S.C.
sroberts on DSK5SPTVN1PROD with NOTICES
1 The
MOA also provided that:
DEA is not precluded from introducing this
Agreement, violations of this Agreement and any
other relevant allegations, whether enumerated
herein or not, that preceded or may ensue during
or after the effective period of this Agreement in
any future administrative proceedings. Further,
nothing in this Agreement shall be construed as a
waiver to use any other grounds for revocation or
denial of a DEA registration, including, but not
limited to, the admissibility of this Agreement and/
or any violations of this Agreement in the event that
future administrative proceedings become
necessary.
GX 4, at 5–6.
VerDate Mar<15>2010
16:56 Oct 27, 2011
Jkt 226001
66969
1956(h) and 1956(a)(1)(A)(i). See GX 7.
On January 10, 2008, Respondent pled
guilty to one count of Conspiracy to
Possess with Intent to Distribute
Hydrocodone, in violation of 21 U.S.C.
841(a)(1) and 846; on August 8, 2008,
the United States District Court entered
its judgment finding him guilty of the
offense and sentenced him to three
years’ probation and 288 hours of
community service. See GX 8.
On April 7, 2009, Respondent
submitted an online application for a
new DEA Certificate of Registration as a
Practitioner in schedules II–V.
Respondent sought registration at the
address of 620 Lady Di Street, Apt. #10,
Parque Los Almendros, Ponce, Puerto
Rico 00716. GX 1, at 1.
On May 26, 2010, the Puerto Rico
Board issued a complaint against
Respondent’s license on the ground that
he had been convicted of a crime
involving moral turpitude. Declaration
of Diversion Investigator, at 2. On
September 2, 2010, Respondent and the
Board’s Investigator agreed to a
settlement; on September 22, the Board
voted to adopt the settlement. Id.
Pursuant to the settlement,
Respondent was allowed to continue
practicing medicine. Id. at 3. However,
Respondent ‘‘[s]urrender[ed] his
capacity to prescribe controlled
substances for a term of three years.’’ Id.
I therefore find that Respondent is
currently without authority to handle
controlled substances in the
Commonwealth of Puerto Rico, the
jurisdiction in which he has sought
registration.
As these provisions make plain,
possessing authority under state law (or
in the case of Puerto Rico, the law of the
Commonwealth) to handle controlled
substances is an essential condition for
obtaining and maintaining a DEA
registration. Steven B. Brown, 75 FR
65660, 65663 (2010) (citing John B.
Freitas, 74 FR 17524, 17525 (2009));
Dominick A. Ricci, 58 FR 51104, 51105
(1993); Bobby Watts, 53 FR 11919,
11920 (1988).
It is undisputed that the Puerto Rico
Board has suspended Respondent’s
authority to dispense controlled
substances in the Commonwealth, the
jurisdiction in which he practices, for a
period of three years, and that he does
not satisfy the CSA’s requirement for
obtaining a registration. See 21 U.S.C.
802(21) & 823(f). Accordingly, his
pending application will be denied.2
Discussion
Section 303(f) of the Controlled
Substances Act (CSA) provides that
‘‘[t]he Attorney General shall register
practitioners * * * to dispense * * *
controlled substances * * * if the
applicant is authorized to dispense
* * * controlled substances under the
laws of the State in which he practices.’’
21 U.S.C. 823(f). Moreover, the CSA
defines ‘‘[t]he term ‘practitioner’ [to]
mean[] a physician * * * licensed,
registered, or otherwise permitted, by
the United States or the jurisdiction in
which he practices * * * to distribute,
dispense, * * * [or] administer * * * a
controlled substance in the course of
professional practice.’’ 21 U.S.C.
802(21). See also id. § 824(a)(3)
(authorizing revocation of a registration
‘‘upon a finding that the registrant
* * * has had his State license or
registration suspended [or] revoked
* * * and is no longer authorized by
State law to engage in the * * *
distribution [or] dispensing of
controlled substances’’).
Drug Enforcement Administration
PO 00000
Frm 00079
Fmt 4703
Sfmt 4703
Order
Pursuant to the authority vested in me
by 21 U.S.C. 823(f), as well as 28 CFR
0.100(b) and 0.104, I order that the
pending application by Abelardo E.
Lecompte-Torres, M.D., for DEA
Certificate of Registration as a
practitioner, be, and it hereby is, denied.
This Order is effective immediately.
Dated: October 17, 2011.
Michele M. Leonhart,
Administrator.
[FR Doc. 2011–27929 Filed 10–27–11; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Aaron Gloskowski, D.O.; Decision and
Order
On March 17, 2011, the Deputy
Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration, issued an Order to
Show Cause to Aaron Gloskowski, D.O.
(Registrant), of Kearny, Arizona. The
Show Cause Order proposed the
revocation of Registrant’s DEA
Certificate of Registration BG6908757,
as a practitioner in Schedules II through
V, and the denial of any pending
applications to renew or modify his
registration, pursuant to 21 U.S.C.
824(a)(3) & (4) and 823(f). Show Cause
Order at 1.
2 While the Government contends that
Respondent’s application should also be denied
based on his involvement in an additional internet
prescribing scheme and his felony conviction for
participating in this scheme, see Request for Final
Agency Action, at 7–9; for the reason stated above,
I conclude that it is unnecessary to address whether
this conduct provides a further ground for denying
his application.
E:\FR\FM\28OCN1.SGM
28OCN1
sroberts on DSK5SPTVN1PROD with NOTICES
66970
Federal Register / Vol. 76, No. 209 / Friday, October 28, 2011 / Notices
More specifically, the Show Cause
Order alleged that as a result of action
by the Arizona Board of Osteopathic
Examiners in Medicine and Surgery
(hereinafter, the Board), Registrant is
without authority to practice medicine
or handle controlled substances in the
State of Arizona, the State in which he
is registered with DEA, and therefore is
not entitled to hold a DEA registration.
Id. at 1–2.
The Show Cause Order also alleged
that pursuant to Registrant’s consent
agreements with the Board, on two
occasions, Registrant provided urine
samples for drug testing, which tested
positive for methamphetamine, a
Schedule I 1 controlled substance. Id. at
2. The Order further alleged that
Registrant has a history of drug abuse
dating to at least November 2008, when
he entered into a Rehabilitation
Agreement with the Board, and that his
self-abuse of a controlled substance is
also a ground for revocation of his DEA
registration. Id. The Order also notified
Registrant of his right to request a
hearing on the allegations or to submit
a written statement in lieu of a hearing,
the procedure for doing either, and the
consequence for failing to do either. Id.
at 2. (citing 21 CFR 1301.43).
The Government initially attempted
to serve the Show Cause Order by
certified mail addressed to Registrant at
his registered address. However, the
mailing was returned to the Government
marked: ‘‘Moved, Left no Address’’ and
‘‘Unable to Forward.’’ Government
Request for Final Agency Action
(Request), at 1.
Registrant was then located by a DEA
Diversion Investigator (DI), who then
resent the Show Cause Order to him by
certified mail; according to a certified
mail receipt, on April 4, 2011,
Registrant was served with the Order.
Request at 1–2. On March 21, 2011, the
Government also emailed the Order to
Registrant; the DI confirmed that
Registrant had received the email and
had opened the attachment containing
the Order. Id. at 2.
Since the date of service of the Show
Cause Order, thirty days have now
passed and neither Registrant, nor
anyone purporting to represent him, has
requested a hearing or submitted a
written statement in lieu of a hearing. I
therefore find that Registrant has waived
his right to a hearing or to submit a
written statement in lieu of a hearing,
and issue this Decision and Final Order
based on relevant evidence contained in
the record submitted by the
1 In fact, methamphetamine is a schedule II
controlled substance. See 21 CFR 1308.l2(d).
VerDate Mar<15>2010
16:56 Oct 27, 2011
Jkt 226001
Government. 21 CFR 1301.43(d) & (e). I
make the following findings of fact.
Findings
Registrant is the holder of DEA
Certificate of Registration BG6908757,
which authorizes him to handle
controlled substances in Schedules II
through V as a practitioner, at the
registered address of 100 Tilbury Drive,
Kearny, Arizona. His registration does
not expire until September 30, 2012.
Registrant was formerly licensed as an
osteopathic physician in Arizona. On
November 21, 2008, Registrant entered
into a Stipulated Rehabilitation
Agreement with the Arizona Board of
Osteopathic Examiners in Medicine and
Surgery, under which he was allowed to
participate in the Board’s confidential
program for the treatment and
rehabilitation of doctors of medicine
who are impaired by alcohol or drug
abuse, pursuant to A.R.S. § 32–1861. See
GX E, at 1 (Stipulated Rehabilitation
Agreement). The Rehabilitation
Agreement was to remain in effect for 5
years. Id. at 3.
The Rehabilitation Agreement
stipulated that any violation of its terms
constituted unprofessional conduct as
defined in A.R.S. § 32–1854,2 and may
have resulted in disciplinary action
pursuant to A.R.S. § 32–1855. Id. at 1.
Therein, Registrant agreed to various
conditions, including that he take only
those medications prescribed to him by
his primary care physician; that he
submit to biological fluid collection for
testing, id. at 4–5; and that in the event
of a relapse, he would enter into an
Interim Consent Agreement for Practice
Restriction that required, among other
things, that he not practice medicine
until such time as he successfully
completed a long-term inpatient or
residential treatment program
designated by the Board. Id. at 7.
On February 25, 2009, the Board was
notified that Registrant had provided a
biological fluid sample which tested
positive for methamphetamine. GX F, at
3 (Consent Agreement and Order For
Probation, June 29, 2009). Upon notice
2 Under Arizona law, ‘‘unprofessional conduct’’
includes, inter alia: ‘‘[p]racticing medicine while
under the influence of alcohol, narcotic or hypnotic
drugs or any substance that impairs or may impair
the licensee’s ability to safely and skillfully practice
medicine’’; ‘‘[e]ngaging in the practice of medicine
in a manner that harms or may harm a patient or
that the Board determines falls below the
community standard’’; ‘‘[v]iolating a formal order,
probation or a stipulation issued by the Board
under this chapter;’’ ‘‘[a]ny conduct or practice that
endangers a patient’s or the public’s health or may
reasonably be expected to do so’’; and ‘‘[a]ny
conduct or practice that impairs the licensee’s
ability to safely and skillfully practice medicine or
that may reasonably be expected to do so.’’ Ariz.
Rev. Stat. § 32–1854 (3), (6), (25), (38), and (39).
PO 00000
Frm 00080
Fmt 4703
Sfmt 4703
from the Executive Director of the
Board, Registrant voluntarily refrained
from practicing medicine, successfully
completed an inpatient treatment
program, and entered an outpatient
program. Id. at 3.
On June 29, 2009, the Board issued an
Interim Order placing Registrant on
probation for five years. The Board
imposed extensive conditions on
Registrant, including that he participate
in the Board’s monitored aftercare
program and participate in the intensive
outpatient program until the program’s
medical director approved his discharge
from it. Id. at 4. The Board also ordered
that he attend a 12-step program or selfhelp group; obtain psychological
counseling; take no medication unless
prescribed by his primary care
physician or in an emergency; consume
no alcohol or poppy seeds; and submit
biological fluid samples upon the
Board’s request with the further
provision that his failure to cooperate in
the collection of such samples ‘‘may be
considered [a] failure to comply with
th[e] Order.’’ Id. at 4–7. Finally, the
Order provided that ‘‘the positive
finding in [Registrant’s] biological fluid
of a drug or medication not prescribed
to [him] in accordance with this Order
shall be considered proof of a relapse,’’
and that in the event of a relapse, his
‘‘license to practice medicine shall be
summarily suspended pending a formal
administrative hearing for revocation.’’
Id. at 7–8.
On June 9, 2010, Registrant submitted
a biological fluid sample for testing
pursuant to the 2009 Order. GX H, at
5–6. As a result of irregularities found
in the sample, Registrant was directed
by the Board to submit an observed
urine test and hair test for sampling. Id.
at 6. Registrant submitted the biological
fluid testing sample; however, the
collected sample had not been
‘‘observed’’ and the chain of custody
form did not indicate ‘‘observed’’ but
‘‘monitored.’’ Id. at 7. The Board then
informed Registrant by letter that all
future biological testing fluid samples
must be observed. Id. at 8.
On July 27, 2010, the day after
meeting with Board staff to discuss his
compliance with the 2009 Order,
Registrant submitted to another urine
test, which tested positive for
amphetamines and methamphetamine.
Based in part on this test result, the
Board summarily suspended
Registrant’s license to practice
osteopathic medicine. GX G, at 3–4.
Following a hearing before a State
Administrative Law Judge (ALJ), the
Board made extensive findings
regarding Registrant’s compliance with
the Consent Order. GX H. Regarding
E:\FR\FM\28OCN1.SGM
28OCN1
Federal Register / Vol. 76, No. 209 / Friday, October 28, 2011 / Notices
Registrant’s July 27, 2010 drug test, the
Board found that while the positive
result for amphetamines could be
explained by a legitimate prescription
Registrant had for Vyvanse, the
methamphetamine result revealed a
high concentration of an isomer which
‘‘marks the biologically active
ingredient in the street drug
methamphetamine that is not normally
prescribed.’’ Id. at 9. While Respondent
argued that he was also taking ClaritinD at the time of the test, the director of
the laboratory that performs biological
fluid testing for the Board, and who
holds a Ph.D. in toxicology, id. at 4,
‘‘testified that he had no doubt
whatsoever that [Registrant’s] July 27,
2010 specimen tested positive for
methamphetamine.’’ Id. at 9, 12. The
Board thus found that Registrant had
‘‘relapsed to substance abuse and
violated the Consent Agreement’’ and
that ‘‘[t]hese acts constitute
unprofessional conduct as defined by’’
Arizona law. Id. at 12 (citing Ariz. Rev.
Stat. § 32–1854(25), (38), and (39)). The
Board further found that Registrant had
failed to accept responsibility ‘‘for his
repeated failures to comply with the
Consent Agreement and his relapse,’’
and revoked his state osteopathic
license. Id. at 12–13.
I therefore find that Registrant is
currently without authority to handle
controlled substances under the laws of
the State of Arizona, the State in which
he is registered with DEA.
sroberts on DSK5SPTVN1PROD with NOTICES
Discussion
The Loss of State Authority Ground
Under the Controlled Substances Act
(CSA), a practitioner must be currently
authorized to handle controlled
substances in the ‘‘jurisdiction in which
he practices’’ in order to maintain a
DEA registration. See 21 U.S.C. 802(21)
(‘‘[t]he term ‘practitioner’ means a
physician * * * licensed, registered, or
otherwise permitted, by * * * the
jurisdiction in which he practices * * *
to distribute, dispense, [or] administer
* * * a controlled substance in the
course of professional practice’’). See
also id. § 823(f) (‘‘The Attorney General
shall register practitioners * * * if the
applicant is authorized to dispense
* * * controlled substances under the
laws of the State in which he
practices.’’). As these provisions make
plain, possessing authority under state
law to handle controlled substances is
an essential condition for obtaining and
maintaining a DEA registration.
Accordingly, DEA has held that
revocation of a registration is warranted
whenever a practitioner’s state authority
to dispense controlled substances has
VerDate Mar<15>2010
16:56 Oct 27, 2011
Jkt 226001
been suspended or revoked. David W.
Wang, 72 FR 54297, 54298 (2007);
Sheran Arden Yeates, 71 FR 39130,
39131 (2006); Dominick A. Ricci, 58 FR
51104, 51105 (1993); Bobby Watts, 53
FR 11919, 11920 (1988). See also 21
U.S.C. 824(a)(3) (authorizing revocation
of a registration ‘‘upon a finding that the
registrant * * * has had his State
license or registration suspended [or]
revoked * * * and is no longer
authorized by State law to engage in the
* * * distribution [or] dispensing of
controlled substances’’).
As found above, on March 22, 2011,
the Arizona Board revoked Registrant’s
state osteopathic medicine license.
Accordingly, Registrant is without
authority to dispense controlled
substances in the State where he
practices medicine and holds his DEA
registration, and is therefore no longer
entitled to hold his registration. See 21
U.S.C. 802 (21), 823(f), 824(a)(3).
Therefore, pursuant to the authority
granted under 21 U.S.C. 824(a)(3), his
registration will be revoked.
66971
(1) The recommendation of the appropriate
State licensing board or professional
disciplinary authority.
(2) The applicant’s experience in
dispensing * * * controlled substances.
(3) The applicant’s conviction record under
Federal or State laws relating to the
manufacture, distribution, or dispensing of
controlled substances.
(4) Compliance with applicable State,
Federal, or local laws relating to controlled
substances.
(5) Such other conduct which may threaten
the public health and safety.
Leslie, 68 FR 15227, 15230 (2003). 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 an
existing registration or to deny an
application for a registration. Id.
Moreover, I am ‘‘not required to make
findings as to all of the factors.’’ Hoxie
v. DEA, 419 F.3d 477, 482 (6th Cir.
2005); see also Morall v. DEA, 412 F.3d
165, 173–74 (DC Cir. 2005).
In this matter, while I have
considered all of the factors, I conclude
that it is not necessary to make findings
with respect to factors one 3 through
four. However, I conclude that factor
five, which authorizes the Agency to
consider ‘‘other such conduct which
may threaten public health and safety,’’
21 U.S.C. 823(f)(5), supports a finding
that Respondent has committed acts
which render his continued
‘‘registration inconsistent with the
public interest.’’ 21 U.S.C. 824(a)(4).
Under longstanding Agency
precedent, factor five encompasses
‘‘wrongful acts relating to controlled
substances committed by a registrant
outside of his professional practice but
which relate to controlled substances.’’
David E. Trawick, 53 FR 5326, 5327
(1988). More recently, I explained that
‘‘DEA has long held that a practitioner’s
self-abuse of a controlled substance is a
relevant consideration under factor five
and has done so even when there is no
evidence that the registrant abused his
prescription writing authority.
Moreover, DEA has revoked
registrations and/or denied applications
for a registration even where there is no
evidence that the practitioner
committed acts involving unlawful
distribution to others.’’ Tony T. Bui,
M.D., 75 FR 49979, 49989 (2010)
(citations omitted.)
As found above, in 2008, Registrant
self-reported to the Arizona Board that
he was beginning in-patient treatment
for substance abuse. GX H, at 3.
Moreover, on two subsequent occasions
(February 25, 2009 and July 27, 2010),
Registrant provided biological
specimens which tested positive for
methamphetamine, in violation of his
agreements with the Board. Of further
significance, the Board found that
Registrant’s July 2010 test sample had a
90% concentration of an isomer which
is the biologically active ingredient in
methamphetamine which is sold on the
street. Id. at 9.
Thus, substantial evidence supports
the conclusion that Registrant has
21 U.S.C. 823(f).
The public interest factors are
considered in the disjunctive. Robert A.
3 For the same reason that supports revocation
under 21 U.S.C. 824(a)(3), factor one would also
support revocation.
The Public Interest Ground
The Government further argues that
Registrant’s abuse of methamphetamine
is an additional ground for revoking his
registration because he has committed
acts that render his registration
inconsistent with the public interest.
Request for Final Agency Action, at 3
(citing 21 U.S.C. 824(a)(4)). I agree.
Section 304(a) of the Controlled
Substances Act provides that a
‘‘registration pursuant to section 823 of
this title to * * * 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). With
respect to a practitioner, the Act
requires the consideration of the
following factors in making the public
interest determination:
PO 00000
Frm 00081
Fmt 4703
Sfmt 4703
E:\FR\FM\28OCN1.SGM
28OCN1
66972
Federal Register / Vol. 76, No. 209 / Friday, October 28, 2011 / Notices
repeatedly engaged in the self–abuse of
a Schedule II controlled substance, and
done so notwithstanding the attempts
by the Arizona Board to assist Registrant
to rehabilitate himself. I therefore hold
that Registrant has engaged in ‘‘such
other conduct which may threaten
public health or safety,’’ 21 U.S.C.
823(f)(5), and that he has committed
acts which render his registration
‘‘inconsistent with the public interest.’’
Id. § 824(a)(4). This conclusion provides
a further reason to revoke Registrant’s
registration and to deny any pending
applications.
Order
Pursuant to the authority vested in me
by 21 U.S.C. 823(f) and 824(a), as well
as 28 CFR 0.100(b), I order that DEA
Certificate of Registration BG6908757,
issued to Aaron Gloskowski, D.O., be,
and it hereby is, revoked. I further order
that any pending application of Aaron
Gloskowski, D.O., to renew or modify
his registration, be, and it hereby is,
denied. This Order is effective
immediately.
Dated: October 7, 2011.
Michele M. Leonhart,
Administrator.
[FR Doc. 2011–28011 Filed 10–27–11; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 10–55]
sroberts on DSK5SPTVN1PROD with NOTICES
Linda Sue Cheek, M.D., Decision and
Order
On December 30, 2010,
Administrative Law Judge (ALJ)
Timothy D. Wing issued the attached
recommended decision. Thereafter,
Respondent filed exceptions to the
decision.
Having reviewed the entire record
including Respondent’s exceptions, I
have decided to adopt the ALJ’s rulings,
findings of fact, conclusions of law, and
recommended order, except as
discussed below. Accordingly, I will
order that Respondent’s application be
denied.
Before proceeding to discuss
Respondent’s exceptions, a discussion
of the ALJ’s consideration of
‘‘community impact’’ evidence is
warranted. See ALJ at 33–35.1 Therein,
the ALJ acknowledged the recent
decision in Gregory Owens, D.D.S., 74
FR 36751 (2009). In Owens, I explicitly
declined to extend the holding of
1 All citations to the ALJ’s decision are to the slip
opinion as issued by him.
VerDate Mar<15>2010
16:56 Oct 27, 2011
Jkt 226001
Pettigrew Rexall Drugs, 64 FR 8855,
8859–60 (1999), which cited evidence
that a pharmacy was ‘‘one of two
pharmacies in a relatively poor,
medically underserved community’’ as
ground for staying a revocation order, to
the case of a prescribing practitioner. 74
FR at 36757. As Owens explained,
‘‘consideration of the socioeconomic
status of a practitioner’s patient
population is not mandated by the text
of either 21 U.S.C. 823(f) or 824(a)(4).’’
Id. Owens further explained that such a
rule is ‘‘unworkable’’ and ‘‘would inject
a new level of complexity into already
complex proceedings and take the
Agency far afield of the purpose of the
CSA’s registration provisions, which is
to prevent diversion.’’ Id.
The ALJ further noted, however, that
in Imran I. Chaudry, M.D., 69 FR 62081,
62083–84 (2004), the Agency had
‘‘considered and given weight to
community impact evidence, without
specifically citing Pettigrew.’’ ALJ at 34.
Notwithstanding the lengthy
explanation Owens provided as to why
community impact evidence is
irrelevant in a proceeding involving a
prescribing practitioner, the ALJ
reasoned that in ‘‘[i]n light of [Chaudry],
I find that community impact evidence
as a threshold matter is not entirely
irrelevant.’’ Id.
While in Chaudry, the Agency noted
that evidence that the respondent, who
was a cardiologist, practiced in a
medically underserved community
‘‘provide[d] some support for
maintaining [his] registration,’’ the
Agency further held that this evidence
‘‘also has a negative implication for
continued registration’’ because
Respondent placed the community at
risk by abusing methamphetamine and
distributing it to another physician. 69
FR at 62084. Thus, in Chaudry, while
the registrant was the only cardiologist
in ‘‘a town of approximately 4,000
people,’’ the Agency actually relied on
this evidence to revoke the
practitioner’s registration.
The decision in Chaudry did not,
however, explain to what factor this
evidence—whether cited in mitigation
by the registrant or cited in aggravation
by the final decision—was relevant.
While it is possible to view such
evidence as relevant (at least when
offered as evidence of an aggravating
circumstance) in determining whether a
registrant has engaged in ‘‘such other
conduct as may threaten public health
and safety,’’ 21 U.S.C. 823(f)(5), a
practitioner’s self-abuse of a controlled
substance ‘‘threaten[s] public health and
safety’’ without regard to the
socioeconomic characteristics of the
PO 00000
Frm 00082
Fmt 4703
Sfmt 4703
community in which he or she
practices.2
Moreover, my review of Chaudry
reinforces the correctness of my
conclusion in Owens. As I explained in
Owens, ‘‘[t]he public interest standard
of 21 U.S.C. § 823(f) is not a
freewheeling inquiry but is guided by
the five specific factors which Congress
directed the Attorney General to
consider; consideration of the
socioeconomic status of a practitioner’s
patient population is not mandated by
the text of either 21 U.S.C. §§ 823(f) or
824(a)(4), which focus primarily on the
acts committed by a practitioner.’’ 74 FR
at 36757.
As I further explained in Owens (as
well as in numerous other cases),
‘‘where the Government has made out a
prima facie case that a practitioner has
committed acts which render [her]
registration inconsistent with the public
interest, the relevant inquiry is * * *
whether the practitioner has put
forward ‘sufficient mitigating evidence
to assure the Administrator that he can
be entrusted with the responsibility
carried by such a registration.’ ’’ Id.
(quoting Medicine ShoppeJonesborough, 73 FR 364, 387 (2008)).
Moreover, in numerous decisions, I
have made clear that ‘‘this inquiry looks
to whether the registrant has accepted
responsibility for [her] misconduct and
undertaken corrective measures to
prevent the re-occurrence of similar
acts.’’ Id. As explained in Owens,
‘‘[w]hether a practitioner treats patients
who come from a medically
underserved community or who have
limited incomes has no bearing on
whether [she] has accepted
responsibility and undertaken adequate
corrective measures.3’’ Id.
In Owens, I also noted that the
diversion of prescription controlled
substances ‘‘has become an increasingly
serious societal problem, which is
particularly significant in poorer
communities whether they are located
in rural or urban areas.’’ Id. (citing
George C. Aycock, 74 FR 17529, 17544
n.33 (2009); Laurence T. McKinney, 73
FR 43260 (2008); Paul H. Volkman, 73
2 While the decision noted that the registrant had
also distributed methamphetamine to another
physician, this conduct would clearly fall within
factor four, ‘‘[c]ompliance with applicable State,
Federal, or local laws relating to controlled
substances.’’ 21 U.S.C. 823(f)(4).
3 Of course, in determining the appropriate
sanction, DEA also considers the extent and
egregiousness of a registrant’s misconduct, the
degree of the registrant’s candor, as well as the
Agency’s interest in deterring others from engaging
in similar acts. See Owens, 74 FR at 36757; Paul
Weir Battershell, 76 FR 44359 (2010); Joseph
Gaudio, 74 FR 10083, 10095 (2009); Janet Thornton,
73 FR 50354 (2008).
E:\FR\FM\28OCN1.SGM
28OCN1
Agencies
[Federal Register Volume 76, Number 209 (Friday, October 28, 2011)]
[Notices]
[Pages 66969-66972]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-28011]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Aaron Gloskowski, D.O.; Decision and Order
On March 17, 2011, the Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement Administration, issued an Order to
Show Cause to Aaron Gloskowski, D.O. (Registrant), of Kearny, Arizona.
The Show Cause Order proposed the revocation of Registrant's DEA
Certificate of Registration BG6908757, as a practitioner in Schedules
II through V, and the denial of any pending applications to renew or
modify his registration, pursuant to 21 U.S.C. 824(a)(3) & (4) and
823(f). Show Cause Order at 1.
[[Page 66970]]
More specifically, the Show Cause Order alleged that as a result of
action by the Arizona Board of Osteopathic Examiners in Medicine and
Surgery (hereinafter, the Board), Registrant is without authority to
practice medicine or handle controlled substances in the State of
Arizona, the State in which he is registered with DEA, and therefore is
not entitled to hold a DEA registration. Id. at 1-2.
The Show Cause Order also alleged that pursuant to Registrant's
consent agreements with the Board, on two occasions, Registrant
provided urine samples for drug testing, which tested positive for
methamphetamine, a Schedule I \1\ controlled substance. Id. at 2. The
Order further alleged that Registrant has a history of drug abuse
dating to at least November 2008, when he entered into a Rehabilitation
Agreement with the Board, and that his self-abuse of a controlled
substance is also a ground for revocation of his DEA registration. Id.
The Order also notified Registrant of his right to request a hearing on
the allegations or to submit a written statement in lieu of a hearing,
the procedure for doing either, and the consequence for failing to do
either. Id. at 2. (citing 21 CFR 1301.43).
---------------------------------------------------------------------------
\1\ In fact, methamphetamine is a schedule II controlled
substance. See 21 CFR 1308.l2(d).
---------------------------------------------------------------------------
The Government initially attempted to serve the Show Cause Order by
certified mail addressed to Registrant at his registered address.
However, the mailing was returned to the Government marked: ``Moved,
Left no Address'' and ``Unable to Forward.'' Government Request for
Final Agency Action (Request), at 1.
Registrant was then located by a DEA Diversion Investigator (DI),
who then resent the Show Cause Order to him by certified mail;
according to a certified mail receipt, on April 4, 2011, Registrant was
served with the Order. Request at 1-2. On March 21, 2011, the
Government also emailed the Order to Registrant; the DI confirmed that
Registrant had received the email and had opened the attachment
containing the Order. Id. at 2.
Since the date of service of the Show Cause Order, thirty days have
now passed and neither Registrant, nor anyone purporting to represent
him, has requested a hearing or submitted a written statement in lieu
of a hearing. I therefore find that Registrant has waived his right to
a hearing or to submit a written statement in lieu of a hearing, and
issue this Decision and Final Order based on relevant evidence
contained in the record submitted by the Government. 21 CFR 1301.43(d)
& (e). I make the following findings of fact.
Findings
Registrant is the holder of DEA Certificate of Registration
BG6908757, which authorizes him to handle controlled substances in
Schedules II through V as a practitioner, at the registered address of
100 Tilbury Drive, Kearny, Arizona. His registration does not expire
until September 30, 2012.
Registrant was formerly licensed as an osteopathic physician in
Arizona. On November 21, 2008, Registrant entered into a Stipulated
Rehabilitation Agreement with the Arizona Board of Osteopathic
Examiners in Medicine and Surgery, under which he was allowed to
participate in the Board's confidential program for the treatment and
rehabilitation of doctors of medicine who are impaired by alcohol or
drug abuse, pursuant to A.R.S. Sec. 32-1861. See GX E, at 1
(Stipulated Rehabilitation Agreement). The Rehabilitation Agreement was
to remain in effect for 5 years. Id. at 3.
The Rehabilitation Agreement stipulated that any violation of its
terms constituted unprofessional conduct as defined in A.R.S. Sec. 32-
1854,\2\ and may have resulted in disciplinary action pursuant to
A.R.S. Sec. 32-1855. Id. at 1. Therein, Registrant agreed to various
conditions, including that he take only those medications prescribed to
him by his primary care physician; that he submit to biological fluid
collection for testing, id. at 4-5; and that in the event of a relapse,
he would enter into an Interim Consent Agreement for Practice
Restriction that required, among other things, that he not practice
medicine until such time as he successfully completed a long-term
inpatient or residential treatment program designated by the Board. Id.
at 7.
---------------------------------------------------------------------------
\2\ Under Arizona law, ``unprofessional conduct'' includes,
inter alia: ``[p]racticing medicine while under the influence of
alcohol, narcotic or hypnotic drugs or any substance that impairs or
may impair the licensee's ability to safely and skillfully practice
medicine''; ``[e]ngaging in the practice of medicine in a manner
that harms or may harm a patient or that the Board determines falls
below the community standard''; ``[v]iolating a formal order,
probation or a stipulation issued by the Board under this chapter;''
``[a]ny conduct or practice that endangers a patient's or the
public's health or may reasonably be expected to do so''; and
``[a]ny conduct or practice that impairs the licensee's ability to
safely and skillfully practice medicine or that may reasonably be
expected to do so.'' Ariz. Rev. Stat. Sec. 32-1854 (3), (6), (25),
(38), and (39).
---------------------------------------------------------------------------
On February 25, 2009, the Board was notified that Registrant had
provided a biological fluid sample which tested positive for
methamphetamine. GX F, at 3 (Consent Agreement and Order For Probation,
June 29, 2009). Upon notice from the Executive Director of the Board,
Registrant voluntarily refrained from practicing medicine, successfully
completed an inpatient treatment program, and entered an outpatient
program. Id. at 3.
On June 29, 2009, the Board issued an Interim Order placing
Registrant on probation for five years. The Board imposed extensive
conditions on Registrant, including that he participate in the Board's
monitored aftercare program and participate in the intensive outpatient
program until the program's medical director approved his discharge
from it. Id. at 4. The Board also ordered that he attend a 12-step
program or self-help group; obtain psychological counseling; take no
medication unless prescribed by his primary care physician or in an
emergency; consume no alcohol or poppy seeds; and submit biological
fluid samples upon the Board's request with the further provision that
his failure to cooperate in the collection of such samples ``may be
considered [a] failure to comply with th[e] Order.'' Id. at 4-7.
Finally, the Order provided that ``the positive finding in
[Registrant's] biological fluid of a drug or medication not prescribed
to [him] in accordance with this Order shall be considered proof of a
relapse,'' and that in the event of a relapse, his ``license to
practice medicine shall be summarily suspended pending a formal
administrative hearing for revocation.'' Id. at 7-8.
On June 9, 2010, Registrant submitted a biological fluid sample for
testing pursuant to the 2009 Order. GX H, at 5-6. As a result of
irregularities found in the sample, Registrant was directed by the
Board to submit an observed urine test and hair test for sampling. Id.
at 6. Registrant submitted the biological fluid testing sample;
however, the collected sample had not been ``observed'' and the chain
of custody form did not indicate ``observed'' but ``monitored.'' Id. at
7. The Board then informed Registrant by letter that all future
biological testing fluid samples must be observed. Id. at 8.
On July 27, 2010, the day after meeting with Board staff to discuss
his compliance with the 2009 Order, Registrant submitted to another
urine test, which tested positive for amphetamines and methamphetamine.
Based in part on this test result, the Board summarily suspended
Registrant's license to practice osteopathic medicine. GX G, at 3-4.
Following a hearing before a State Administrative Law Judge (ALJ),
the Board made extensive findings regarding Registrant's compliance
with the Consent Order. GX H. Regarding
[[Page 66971]]
Registrant's July 27, 2010 drug test, the Board found that while the
positive result for amphetamines could be explained by a legitimate
prescription Registrant had for Vyvanse, the methamphetamine result
revealed a high concentration of an isomer which ``marks the
biologically active ingredient in the street drug methamphetamine that
is not normally prescribed.'' Id. at 9. While Respondent argued that he
was also taking Claritin-D at the time of the test, the director of the
laboratory that performs biological fluid testing for the Board, and
who holds a Ph.D. in toxicology, id. at 4, ``testified that he had no
doubt whatsoever that [Registrant's] July 27, 2010 specimen tested
positive for methamphetamine.'' Id. at 9, 12. The Board thus found that
Registrant had ``relapsed to substance abuse and violated the Consent
Agreement'' and that ``[t]hese acts constitute unprofessional conduct
as defined by'' Arizona law. Id. at 12 (citing Ariz. Rev. Stat. Sec.
32-1854(25), (38), and (39)). The Board further found that Registrant
had failed to accept responsibility ``for his repeated failures to
comply with the Consent Agreement and his relapse,'' and revoked his
state osteopathic license. Id. at 12-13.
I therefore find that Registrant is currently without authority to
handle controlled substances under the laws of the State of Arizona,
the State in which he is registered with DEA.
Discussion
The Loss of State Authority Ground
Under the Controlled Substances Act (CSA), a practitioner must be
currently authorized to handle controlled substances in the
``jurisdiction in which he practices'' in order to maintain a DEA
registration. See 21 U.S.C. 802(21) (``[t]he term `practitioner' means
a physician * * * licensed, registered, or otherwise permitted, by * *
* the jurisdiction in which he practices * * * to distribute, dispense,
[or] administer * * * a controlled substance in the course of
professional practice''). See also id. Sec. 823(f) (``The Attorney
General shall register practitioners * * * if the applicant is
authorized to dispense * * * controlled substances under the laws of
the State in which he practices.''). As these provisions make plain,
possessing authority under state law to handle controlled substances is
an essential condition for obtaining and maintaining a DEA
registration.
Accordingly, DEA has held that revocation of a registration is
warranted whenever a practitioner's state authority to dispense
controlled substances has been suspended or revoked. David W. Wang, 72
FR 54297, 54298 (2007); Sheran Arden Yeates, 71 FR 39130, 39131 (2006);
Dominick A. Ricci, 58 FR 51104, 51105 (1993); Bobby Watts, 53 FR 11919,
11920 (1988). See also 21 U.S.C. 824(a)(3) (authorizing revocation of a
registration ``upon a finding that the registrant * * * has had his
State license or registration suspended [or] revoked * * * and is no
longer authorized by State law to engage in the * * * distribution [or]
dispensing of controlled substances'').
As found above, on March 22, 2011, the Arizona Board revoked
Registrant's state osteopathic medicine license. Accordingly,
Registrant is without authority to dispense controlled substances in
the State where he practices medicine and holds his DEA registration,
and is therefore no longer entitled to hold his registration. See 21
U.S.C. 802 (21), 823(f), 824(a)(3). Therefore, pursuant to the
authority granted under 21 U.S.C. 824(a)(3), his registration will be
revoked.
The Public Interest Ground
The Government further argues that Registrant's abuse of
methamphetamine is an additional ground for revoking his registration
because he has committed acts that render his registration inconsistent
with the public interest. Request for Final Agency Action, at 3 (citing
21 U.S.C. 824(a)(4)). I agree.
Section 304(a) of the Controlled Substances Act provides that a
``registration pursuant to section 823 of this title to * * * 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). With respect to a practitioner, the Act
requires the consideration of 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 * * * 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 public interest factors are considered in the disjunctive.
Robert A. Leslie, 68 FR 15227, 15230 (2003). 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 an existing registration
or to deny an application for a registration. Id. Moreover, I am ``not
required to make findings as to all of the factors.'' Hoxie v. DEA, 419
F.3d 477, 482 (6th Cir. 2005); see also Morall v. DEA, 412 F.3d 165,
173-74 (DC Cir. 2005).
In this matter, while I have considered all of the factors, I
conclude that it is not necessary to make findings with respect to
factors one \3\ through four. However, I conclude that factor five,
which authorizes the Agency to consider ``other such conduct which may
threaten public health and safety,'' 21 U.S.C. 823(f)(5), supports a
finding that Respondent has committed acts which render his continued
``registration inconsistent with the public interest.'' 21 U.S.C.
824(a)(4).
---------------------------------------------------------------------------
\3\ For the same reason that supports revocation under 21 U.S.C.
824(a)(3), factor one would also support revocation.
---------------------------------------------------------------------------
Under longstanding Agency precedent, factor five encompasses
``wrongful acts relating to controlled substances committed by a
registrant outside of his professional practice but which relate to
controlled substances.'' David E. Trawick, 53 FR 5326, 5327 (1988).
More recently, I explained that ``DEA has long held that a
practitioner's self-abuse of a controlled substance is a relevant
consideration under factor five and has done so even when there is no
evidence that the registrant abused his prescription writing authority.
Moreover, DEA has revoked registrations and/or denied applications for
a registration even where there is no evidence that the practitioner
committed acts involving unlawful distribution to others.'' Tony T.
Bui, M.D., 75 FR 49979, 49989 (2010) (citations omitted.)
As found above, in 2008, Registrant self-reported to the Arizona
Board that he was beginning in-patient treatment for substance abuse.
GX H, at 3. Moreover, on two subsequent occasions (February 25, 2009
and July 27, 2010), Registrant provided biological specimens which
tested positive for methamphetamine, in violation of his agreements
with the Board. Of further significance, the Board found that
Registrant's July 2010 test sample had a 90% concentration of an isomer
which is the biologically active ingredient in methamphetamine which is
sold on the street. Id. at 9.
Thus, substantial evidence supports the conclusion that Registrant
has
[[Page 66972]]
repeatedly engaged in the self-abuse of a Schedule II controlled
substance, and done so notwithstanding the attempts by the Arizona
Board to assist Registrant to rehabilitate himself. I therefore hold
that Registrant has engaged in ``such other conduct which may threaten
public health or safety,'' 21 U.S.C. 823(f)(5), and that he has
committed acts which render his registration ``inconsistent with the
public interest.'' Id. Sec. 824(a)(4). This conclusion provides a
further reason to revoke Registrant's registration and to deny any
pending applications.
Order
Pursuant to the authority vested in me by 21 U.S.C. 823(f) and
824(a), as well as 28 CFR 0.100(b), I order that DEA Certificate of
Registration BG6908757, issued to Aaron Gloskowski, D.O., be, and it
hereby is, revoked. I further order that any pending application of
Aaron Gloskowski, D.O., to renew or modify his registration, be, and it
hereby is, denied. This Order is effective immediately.
Dated: October 7, 2011.
Michele M. Leonhart,
Administrator.
[FR Doc. 2011-28011 Filed 10-27-11; 8:45 am]
BILLING CODE 4410-09-P