[Federal Register Volume 76, Number 222 (Thursday, November 17, 2011)]
[Notices]
[Pages 71375-71378]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-29722]


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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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