Registrant Actions - 2011
[Federal Register Volume 76, Number 222 (Thursday, November 17, 2011)]
[Notices]
[Pages 71375-71378]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-29722]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Scott D. Fedosky, M.D.; Denial of Application
On March 30, 2010, the Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement Administration, issued an Order to
Show Cause to Scott D. Fedosky, M.D. (Respondent), of Fayetteville,
Arkansas. The Show Cause Order proposed the denial of Respondent's
pending application for a DEA Certificate of Registration as a
practitioner, on the ground that his "registration would be
inconsistent with the public interest." Show Cause Order, at 1 (citing
21 U.S.C. 823(f)).
More specifically, the Show Cause Order alleged that "from
December 1999 through September 2003," Respondent had "issued
fraudulent prescriptions for
[[Page 71376]]
controlled substances, specifically hydrocodone under other names to
obtain [the drug] for [his] personal use," and that he had
"voluntarily surrendered" his previous registration "for cause."
Id. at 1. The Show Cause Order further alleged that on February 16,
2006, Respondent applied for a new registration but that he
"[s]ubsequently * * * admitted to obtaining and diverting the
controlled substance, Nubain for [his] own use and voluntarily withdrew
[his] application for registration." Id. Finally, the Show Cause Order
alleged that Respondent "illegally possessed controlled substances in
violation of the Arkansas Medical Practice Act" and that his
"repeated drug abuse and diversion of controlled substances is
inconsistent with the public interest." Id. at 2.
On May 3, 2010, Respondent submitted a letter to the Hearing Clerk,
Office of Administrative Law Judges, in which he acknowledged receipt
of the Show Cause Order. Letter from Respondent to Hearing Clerk (May
3, 2010). Respondent further waived his right to a hearing and
submitted the letter "as a written statement of position." Id.
Thereafter, the Government filed with my Office a Request for Final
Agency Action along with the Investigative Record.
Having considered the entire record, including Respondent's
statement of position and supporting letter, I conclude that the
Government has made out a prima facie case to deny his application. I
further conclude that while Respondent has accepted responsibility for
his misconduct, his evidence is not sufficient to establish that he can
be entrusted with a new registration. Accordingly, his application will
be denied. I make the following findings of fact.
Findings
On June 12, 2009, Respondent, who holds a medical license issued by
the Arkansas State Medical Board, applied for a DEA Certificate of
Registration as a practitioner in schedules II through V. Respondent
previously held DEA Registration BF5374234. However, between December
1999 and September 2003, Respondent wrote fraudulent prescriptions for
hydrocodone, a schedule III controlled substance, "in the name of
family members and an individual identified as 'S.J.'" to obtain drugs
which he diverted "for his own use." Order at 1, In re Scott David
Fedosky, M.D. (Ark. Med. Bd. Feb. 17, 2004). On October 8, 2003,
Respondent voluntarily surrendered his registration.
On February 6, 2004, Respondent appeared before the Arkansas Board.
Id. On February 17, 2004, the Board found that Respondent had
"violated the laws of the United States or the State of Arkansas
regulating the possession, distribution and prescribing of scheduled
medication, more specifically, the writing of fraudulent prescriptions
for scheduled medication and diverting the same for his own use and
benefit." Id. The Board also found that Respondent had violated state
law in that he "ha[d] exhibited habitual or excessive use of narcotics
or other dangerous or habit forming drugs." Id. The Board then revoked
Respondent's medical license but stayed the revocation provided that
he, inter alia, enter into, and comply with, a "rehabilitation and
monitoring" contract "with the Arkansas Medical Foundation for five
(5) years." Id. at 2.
Pursuant to the contract, Respondent was required "to refrain from
the use of any scheduled medication not prescribed by a physician" and
from taking any prescribed medication prior to reporting it to the
Arkansas Medical Foundation; he was also required "to attend
meetings" of one of several self-help organizations such as AA or NA
and to provide proof of his attendance to the Foundation. Order at 2,
In re Scott David Fedosky, M.D. (Ark. Med. Bd. Feb. 9, 2005). However,
on October 20, 2004, Respondent "tested positive for a metabolite of
Propoxyphene, thus violating the terms of his contract with the"
Foundation. Id. at 3. Moreover, Respondent also failed to attend
Caduceus meetings as required by his contract. Id.
The Board thus found that Respondent had violated its previous
order and the Arkansas Medical Practice Act, and required him to enter
into a new five-year contract with the Arkansas Medical Foundation. Id.
The Board also required Respondent to undergo a psychiatric evaluation,
that he provide reports from his psychiatrist every two months, and
that he "obtain a sponsor to counsel him and assist him in
rehabilitation"; the Board also re-imposed the other conditions of the
2004 order. Id.; see also Amendment to Order at 1 (Ark. Med. Bd. Mar.
31, 2005).
On June 8, 2006, the Board conducted another hearing, at which it
found that Respondent had "obtained and diverted for his own use
Nalbuphine," and had thus violated his contract with the Arkansas
Medical Foundation. Order at 2, In re Scott David Fedosky, M.D., (Ark.
Med. Bd. June 21, 2006). The Board again found that Respondent had
violated the Medical Practice Act, its February 9, 2005 order, as well
his contract "by taking controlled substances or mind altering
drugs." Id. The Board then revoked Respondent's medical license. Id.
at 3.
On December 7, 2007, Respondent appeared before the Board to
discuss his status. The Board agreed to allow him to reapply upon his
presenting proof that he had passed the Special Purpose Examination,
which is used to assess a previously licensed (or currently licensed)
physician's level of medical knowledge. On February 7, 2008, Respondent
appeared before the Board and presented evidence that he had passed the
examination. The Board then voted to reinstate Respondent's medical
license with the stipulations that he continue to comply with his
contract with the Arkansas Medical Foundation and that he attend
Caduceus meetings; the Board, however, barred him from re-applying for
a DEA registration.
On October 3, 2008, Respondent again appeared before the Board and
sought permission to re-apply for a DEA registration. The Board,
however, unanimously rejected his request. On June 5, 2009, Respondent
again appeared before the Board and sought permission to re-apply for a
DEA registration. The Board voted unanimously to approve his request.
DEA, however, denied his request and served him with the Show Cause
Order, which initiated this proceeding.
In his letter which he submitted in lieu of his hearing, Respondent
wrote that he had "carefully reviewed the information in the Order To
Show Cause," that "DEA rightfully accepted the surrender of [his]
license [in] 2004," and that "the history as set forth [in the Order]
is factual." Resp. Ltr. at 1. Continuing, Respondent wrote: "The fact
that the prescriptions were obtained fraudulently understandably
creates the issue of self treatment and misuse of the privilege of a
DEA license and could be construed as my being a threat to the public
welfare." Id. Acknowledging that his medical license had been revoked
for this reason, Respondent explained that "[s]ince that time I have
come to a very real understanding that having a license to practice
medicine is a privilege and not a right connected to my level of
education. My DEA license was also a privilege that I did not, at that
time, appreciate or protect as I should have." Id.
Respondent also wrote that he had "voluntarily entered into a
monitoring program with the Arkansas Medical Foundation in September
2006 and have documented sobriety since that time," and that the
Arkansas Board, has "deemed it appropriate for me to reapply for the
DEA registration, giving their support in June 2009." Id.
[[Page 71377]]
Respondent stated that in his sixteen years of medical practice, he had
never harmed a patient nor ever been the subject of a complaint by a
patient. He further explained that:
I have other accountability factors in my life that are a part
of my current situation that is markedly different than my previous
situation. These include, but are not limited to, attending 12 step
and caduceus meetings regularly, continued monitoring by the
Arkansas Medical Foundation and the Arkansas State Medical Board and
the strong support of my spouse, my family and my friends.
Id. Respondent thus maintained that he does "not pose a threat to the
public" and "respectfully request[ed] reinstatement of [his] DEA
license." Id.
In support of his application, Respondent submitted two other
documents: 1) A May 3, 2010 letter from J.B.B., an attorney who stated
that he is a friend of Respondent; and 2) a June 15, 2009 letter from
the Executive Secretary of the Arkansas State Medical Board. In his
letter, J.B.B. acknowledged "that there has been good reason for
[Respondent] not to have a license," but that there are three reasons
why he believed his application should be granted. These were: (1) That
no patient had ever filed a complaint against Respondent; (2) that no
physician or pharmacist had ever filed a complaint against him "for
over prescribing or mis-prescribing to a patient," and (3) that he had
only "prescribed to himself and had done no harm to the public."
J.B.B. further stated his "opinion that [Respondent] has adequately
addressed his personal problem fully."
The Medical Board's letter noted that Respondent had appeared
before it during the June 4-5 meeting. The letter further stated that
the Board had voted to allow him "to reapply for [his] DEA permit."
Discussion
Section 303(f) of the Controlled Substances Act (CSA) provides that
an application for a practitioner's registration may be denied upon a
determination "that the issuance of such registration would be
inconsistent with the public interest." 21 U.S.C. 823(f). In making
the public interest determination in the case of a practitioner,
Congress directed that the following factors be considered:
(1) The recommendation of the appropriate State licensing board
or professional disciplinary authority.
(2) The applicant's experience in dispensing * * * controlled
substances.
(3) The applicant's conviction record under Federal or State
laws relating to the manufacture, distribution, or dispensing of
controlled substances.
(4) Compliance with applicable State, Federal, or local laws
relating to controlled substances.
(5) Such other conduct which may threaten the public health and
safety.
Id.
"[T]hese factors are considered in the disjunctive." Robert A.
Leslie, 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 deny an application. 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) (citing
Morall v. DEA, 412 F.3d 165, 173-74 (DC Cir. 2005)).
In the case of a practitioner, the Government has the burden of
proving with substantial evidence that granting an application would be
inconsistent with the public interest. However, where the Government
makes out a prima facie case to deny an application, the burden shifts
to the applicant to show why granting the application would be
consistent with the public interest.
In this matter, I conclude that the Government has established a
prima facie case to deny Respondent's application. While I find that
Respondent's written statement establishes that he has accepted
responsibility for his misconduct, I conclude that he has not produced
sufficient evidence on the issue of his rehabilitation.
Factors One and Three--the Recommendation of the State Licensing Board
and Respondent's Record of Convictions Related to the Manufacture,
Distribution or Dispensing of Controlled Substances
The record establishes that on June 5, 2009, Respondent appeared
before the Arkansas State Medical Board and that the Board voted to
allow him to apply for a new DEA registration. However, neither the
Executive Secretary's letter, nor the minutes of the Board's June 5,
2009 meeting, state that the Board was recommending that DEA grant his
application.
Accordingly, while Respondent now satisfies the CSA's requirement
for obtaining a registration that he be "authorized to dispense * * *
controlled substances under the laws of the State in which he
practices," 21 U.S.C. 823(f), under Agency precedent, this factor is
not dispositive of the public interest inquiry. Patrick Stodola, 74 FR
20727, 20730 n.16 (2009); Mortimer Levin, 57 FR 8680, 8681 (1992).
I also note that there is no evidence in the record that Respondent
has been convicted of an offense under either Federal or State law
related to manufacture, distribution, or dispensing of a controlled
substance. This factor thus supports a finding that granting
Respondent's application would not be inconsistent with the public
interest. However, because there are multiple reasons why a person may
never be convicted of a criminal offense falling under factor three,
let alone prosecuted for such an offense, DEA has long held that this
factor is not dispositive. Edmund Chein, 72 FR 6580, 6593 n.22 (2007).
Factors Two, Four, and Five--Respondent's Experience in Dispensing
Controlled Substances, Record of Compliance With Applicable Laws
Related to Controlled Substances, and Such Other Conduct Which May
Threaten Public Health and Safety
As established by the Arkansas Board's findings, between December
1999 and September 2003, Respondent wrote fraudulent prescriptions for
hydrocodone, a schedule III narcotic,\1\ in the names of family members
and another individual, to obtain drugs which he then personally
abused. Under Federal law, it is "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).\2\ The Board also found that
Respondent violated state law by "exhibit[ing] habitual or excessive
use of narcotics or other dangerous or habit forming drugs." Order at
1, In re Scott David Fedosky, M.D. (Ark. Med. Bd. Feb. 17, 2004)
(citing Ark. Code Ann. Sec. 17-95-409(a)(2)(h)).
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\1\ See 21 CFR 1308.13(e).
\2\ This was also a violation of Arkansas law.
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While the Board placed Respondent on probation and required that he
enter into a rehabilitation and monitoring contract with the Arkansas
Medical Foundation, which prohibited him from taking any scheduled
medication that was not prescribed to him by a physician, approximately
eight months later, he tested positive for a metabolite of
propoxyphene, a schedule IV narcotic; \3\ in addition, the Board found
that Respondent had failed to attend Caduceus meetings. The Board found
that Respondent had violated its previous order (and his contract with
the Foundation), required that he enter into a new five-year contract
with the Foundation and imposed additional
[[Page 71378]]
terms, including that he undergo a psychiatric evaluation and submit
reports from his psychiatrist to the Board every two months. However,
on June 8, 2006, the Board found that Respondent had "obtained and
diverted to his own use Nalbuphine," and thus violated both Arkansas
law and his rehabilitation and monitoring contract.
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\3\ See 21 CFR 1308.14(b).
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Contrary to the allegations of the Show Cause Order, Nalbuphine is
not a federally controlled substance. See 21 CFR Pt. 1308. The record
nonetheless establishes that Respondent issued fraudulent prescriptions
for hydrocodone, which he then diverted, and that he has abused both
hydrocodone and propoxyphene. See 21 U.S.C. 843(a)(3); see also id.
844(a) ("It shall be unlawful for any person knowingly or
intentionally to possess a controlled substance unless such substance
was obtained directly, or pursuant to a valid prescription or order,
from a practitioner, while acting in the course of his professional
practice, or except as otherwise authorized by this subchapter * * *
."). In addition to these violations, which are properly considered
under Factors Two and Four, DEA has also long held that a
practitioner's self-abuse of a controlled substance can be considered
under Factor Five even if there is no evidence that the practitioner
abused his prescription-writing authority or otherwise engaged in an
unlawful distribution to others. See Tony T. Bui, M.D., 75 FR 49979,
49989-90 (2010) (collecting cases); see also David E. Trawick, 53 FR
5326, 5327 (1988). Accordingly, I conclude that the Government has
established a prima facie case to deny Respondent's application.
Where, as here, "the Government has proved that a registrant has
committed acts inconsistent with the public interest, a registrant must
'present sufficient mitigating evidence to assure the Administrator
that [he] can be entrusted with the responsibility carried by such a
registration.' " \4\ Medicine Shoppe-Jonesborough, 73 FR 364, 387
(2008) (quoting Samuel S. Jackson, 72 FR 23848, 23853 (2007) (quoting
Leo R. Miller, 53 FR 21931, 21932 (1988))), aff'd, Medicine Shoppe-
Jonesborough v. DEA, 300 Fed. Appx. 409 (6th Cir. 2008). "Moreover,
because 'past performance is the best predictor of future performance,'
ALRA Labs, Inc. v. DEA, 54 F.3d 450, 452 (7th Cir. 1995), [DEA] has
repeatedly held that where a registrant has committed acts inconsistent
with the public interest, the registrant must accept responsibility for
[his] actions and demonstrate that [he] will not engage in future
misconduct." Medicine Shoppe, 73 FR at 387; accord Jackson, 72 FR at
23853; John H. Kennedy, 71 FR 35705, 35709 (2006); Prince George
Daniels, 60 FR 62884, 62887 (1995). See also Hoxie v. DEA, 419 F.3d at
483 ("admitting fault" is "properly consider[ed]" by DEA to be an
"important factor[ ]" in the public interest determination).
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\4\ This Agency has repeatedly held that a proceeding under
section 303 "is a remedial measure, based upon the public interest
and the necessity to protect the public from those individuals who
have misused * * * their DEA Certificate of Registration, and who
have not presented sufficient mitigating evidence to assure the
Administrator that they can be entrusted with the responsibility
carried by such a registration." Jackson, 72 FR at 23853 (quoting
Miller, 53 FR at 21932).
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In his statement of position, Respondent acknowledged that the
allegations set forth in the Show Cause Order were "factual" and that
the Agency had "rightfully accepted the surrender of" his DEA
registration. Respondent further explained that "[t]he fact that the
prescriptions were obtained fraudulently understandably creates the
issue of self treatment and misuse of the privilege of a DEA license
and [that his conduct] could be construed as * * * being a threat to
the public welfare." Respondent also wrote that he now recognizes that
holding a DEA registration is "a privilege" which he did not
previously "appreciate or protect as I should have." I conclude that
Respondent's statement is sufficient, even though it is unsworn, to
establish that he accepts responsibility for his misconduct.
However, as explained above, to successfully rebut the Government's
prima facie case, Respondent must also present sufficient evidence to
establish that he will not repeat his prior misconduct. While
Respondent explained that he has "other accountability factors in
[his] life," which he did not have at the time he was self-abusing
controlled substances, such as his attendance at 12-step and Caduceus
meetings, as well as monitoring by the Arkansas Medical Foundation and
Arkansas State Medical Board; that he has "documented sobriety" since
September 2006; and that he has "the strong support of" his family
and friends; he did not produce any evidence to corroborate any of
these statements. More specifically, he did not produce the testimony
or reports of those professionals who have evaluated and treated him,
as well as of those persons who have sponsored him at various recovery
meetings. In addition, there is no evidence establishing the extent to
which he has been subject to random drug testing and the results of
such tests. See Steven M. Abbadessa, 74 FR 10077, 10079-80 (2009)
(discussing evidence sufficient to support practitioner's claim of
rehabilitation).\5\
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\5\ While I have also considered J.B.B.'s letter, it offers no
factual support for Respondent's claim that he is rehabilitated.
Instead, it offers only his personal opinion that Respondent's has
"adequately addressed his personal problem fully."
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I therefore conclude that Respondent has not rebutted the
Government's prima facie case. Accordingly, I will deny Respondent's
application.
Order
Pursuant to the authority vested in me by 21 U.S.C. 823(f), as well
as 28 CFR 0.100(b) & 0.104, I order that the application of Scott D.
Fedosky, M.D., for a DEA Certificate of Registration as a practitioner
be, and it hereby is, denied. This order is effective December 19,
2011.
Dated: November 8, 2011.
Michele M. Leonhart,
Administrator.
[FR Doc. 2011-29722 Filed 11-16-11; 8:45 am]
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