[Federal Register Volume 76, Number 58 (Friday, March 25, 2011)]
[Notices]
[Pages 16835-16838]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-7047]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Erwin E. Feldman, D.O.; Revocation of Registration

    On May 29, 2009, the Deputy Assistant Administrator, Office of 
Diversion Control, Drug Enforcement Administration, issued an Order to 
Show Cause to Erwin E. Feldman, D.O. (Respondent), of Madison Heights, 
Michigan. The Show Cause Order proposed the revocation of Respondent's 
DEA Certificate of Registration, AF9086415, which authorizes him to 
dispense controlled substances as a practitioner, and the denial of any 
pending applications to renew his registration, on the ground that his 
``continued registration is inconsistent with the public interest.'' 
Show Cause Order at 1 (citing 21 U.S.C. 823(f) and 824(a)).
    More specifically, the Show Cause Order alleged that on January 18, 
2005, DEA issued an Order to Show Cause to Respondent, which alleged, 
inter alia, that between December 2001 and July 2004, he had prescribed 
controlled substances on ten occasions to undercover agents without 
performing a medical examination, and that he had issued prescriptions 
for Suboxone ``to treat opiate addiction without having obtained'' 
certification from the Michigan Center for Substance Abuse Treatment 
and a separate DEA registration to prescribe controlled substances for 
``maintenance and detoxification treatment of opiate addiction as 
required by 21 U.S.C. 823(g).'' Id. at 1-2.
    Next, the Show Cause Order alleged that on April 4, 2007, 
Respondent entered into a Memorandum of Agreement (MOA) with the Agency 
to resolve the allegations of the 2005 Show Cause Order, which was to 
remain in force through May 2010. Id. at 2. The Show Cause Order then 
alleged that under the MOA, Respondent agreed that he would prescribe 
controlled substances for only a thirty-day supply with one refill; 
that he would not prescribe controlled substances to persons who were 
not residents of the State of Michigan; that he would not prescribe 
controlled substances to family members; that he would maintain a log 
of all controlled substance prescriptions he issued; that he would 
maintain in patient charts, reports from the Michigan Automated 
Prescriptions System (MAPS) for all patients who received controlled 
substances from him for ``in excess of six months''; and that he would 
notify DEA ``in writing, within twenty days of the initiation of any 
proceedings which impacted [his] ability to handle controlled 
substances, including the initiation of any action by a state entity to 
restrict, deny, rescind, suspend, revoke or otherwise limit [his] 
authority to handle controlled substances.'' Id.
    Finally, the Show Cause Order alleged that Respondent had violated 
the MOA. Id. The Order specifically alleged that ``on several 
occasions,'' Respondent had issued controlled substance prescriptions 
``with as many as seven refills''; that he had prescribed controlled 
substances to residents of Florida and Colorado; that he had prescribed 
Phenobarbital, a schedule IV

[[Page 16836]]

controlled substance, to his wife; that he had failed to maintain an 
accurate log of his controlled substance prescriptions; that he had 
failed to maintain MAPS reports for those patients he prescribed 
controlled substances to for more than six months; and that he had 
``failed to notify DEA in writing'' that on November 3, 2008, the 
Michigan Board of Osteopathic Medicine and Surgery had filed an 
administrative complaint against his medical license. Id.
    Respondent requested a hearing on the allegations, and the matter 
was placed on the docket of the Agency's Administrative Law Judges 
(ALJs). Thereafter, the ALJ ordered the parties to file pre-hearing 
statements. Ex. 6. On July 27, 2009, the Government filed its pre-
hearing statement; on August 17, Respondent's counsel filed a notice of 
appearance and requested a two-week extension to file Respondent's pre-
hearing statement. Id. The record does not disclose what action the ALJ 
took in response to Respondent's request for an extension. However, on 
September 4, the ALJ issued a ``Notice to Show Cause Why the Proceeding 
Should Not Be Terminated'' and gave Respondent ``until September 18 to 
respond.'' Id. On September 21, Respondent's counsel faxed a document 
which bore the caption of Respondent's Pre-Hearing Statement. Id. 
However, when several pages appeared to be missing, the ALJ's office 
left telephone messages on September 21, 22 and 23 with Respondent's 
counsel, notifying him that the entire document had not been received. 
Id.
    On September 28, the ALJ issued another ``Notice to Show Cause Why 
the Proceeding Should Not Be Terminated'' and gave Respondent until 
October 1 to file a response. Id. However, on October 20, 2009, the ALJ 
ordered that the proceeding be terminated, noting that Respondent had 
not filed a response to the order. Id. The ALJ further ``conclude[d] 
that Respondent has waived his right to a hearing.'' Order Terminating 
Proceedings, at 1.
    Thereafter, the Investigative Record was forwarded to this Office 
for final agency action. Having reviewed the entire record in this 
matter, I adopt the ALJ's finding that Respondent has waived his right 
to a hearing. See 21 CFR 1301.43(d). I make the following findings of 
fact.

Findings

    Respondent is the holder of DEA Certificate of Registration, 
AF9086415, which authorizes him to dispense controlled substances in 
schedules II through V as a practitioner. Respondent's registration was 
due to expire on September 30, 2008; however, on September 22, 2008, 
Respondent submitted a renewal application. Because Respondent's 
renewal application was timely submitted, I find that Respondent's 
registration remains in effect pending the issuance of this Decision 
and Final Order. See 5 U.S.C. 558(c). Moreover, on March 17, 2010, 
Respondent submitted a further application for registration as a 
practitioner. See GX 2.
    On January 18, 2005, the Deputy Assistant Administrator, Office of 
Diversion Control, issued an Order to Show Cause to Respondent, which 
proposed the revocation of his registration. GX 3. The 2005 Show Cause 
Order alleged that Respondent had ``issued numerous prescriptions for 
controlled substances to'' an addict, and that he had continued to 
prescribe controlled substances to patient P.H. even after he became 
aware that P.H. had been admitted to a hospital following an overdose. 
Id. at 2-3. This Show Cause Order further alleged that between December 
2001 and July 2004, four DEA Agents made undercover visits to 
Respondent and that on at least ten occasions, the Agents had obtained 
prescriptions ``without having received any type of medical exam.'' Id. 
at 3.
    The 2005 Show Cause Order also alleged that Respondent was engaged 
in family practice, that he issued a substantially greater number of 
controlled-substance prescriptions than four other family practice 
physicians who practiced at the same medical office building, and that 
he had issued approximately 59% of the controlled substance 
prescriptions which were dispensed by the Oakland Medical Pharmacy, 
which was located in the same building. Id. at 1, 4-5. Finally, the 
Show Cause Order alleged that Respondent had prescribed Suboxone to 
three patients even though he did not possess a certification issued by 
the Michigan Center for Substance Abuse Treatment or a DEA registration 
to prescribe controlled substances for maintenance and detoxification 
treatment; the Order also alleged that he had prescribed Suboxone to 
three patients simultaneously with other controlled substances which 
were contraindicated. Id. at 5-6.
    Respondent requested a hearing on the allegations of the 2005 Show 
Cause Order. Thereafter, the parties settled the matter and entered 
into a Memorandum of Agreement (MOA), under which the Agency agreed to 
renew Respondent's registration subject to various terms as set forth 
in the MOA. The MOA, which became effective on May 21, 2007, was to 
remain in force for a period of three years. GX 5, at 2 & 5.
    More specifically, Respondent agreed to limit his controlled 
substance activities ``to prescribing only,'' that he would prescribe a 
controlled substance for only a thirty-day supply with one refill, and 
that he would issue a new controlled-substance prescription only after 
a patient visited with him. Id. at 2. Respondent also agreed that he 
would not prescribe controlled substances to persons who were not 
residents of the State of Michigan; that he would not prescribe 
controlled substances ``to members of his immediate family''; that he 
would maintain a quarterly log of all controlled-substance 
prescriptions he issued which would be available to DEA personnel on 
request; and that in his patient charts, he would maintain reports from 
the Michigan Automated Prescriptions System (MAPS) for all patients who 
received controlled substances from him for ``in excess of six 
months.'' Id. at 2-3.
    Respondent also agreed that he would not ``delegate to any 
pharmacist authorization to dispense'' a new controlled-substance 
prescription ``or refill an existing prescription * * * prior to 
speaking with [him] or his designated representative * * * unless such 
prescription is pursuant to a lawful prescription order by [him].'' Id. 
at 3. Respondent further agreed to notify DEA ``in writing, within 
twenty days of the initiation of any proceedings which impacted [his] 
ability to handle controlled substances, including the initiation of 
any action by a state entity to restrict, deny, rescind, suspend, 
revoke or otherwise limit [his] authority to handle controlled 
substances.'' Id. at 4. Finally, Respondent agreed that ``if he 
violate[d] any term or condition of [the MOA], such violation could 
result in [the] initiation of proceedings to revoke his'' DEA 
registration. Id. at 4-5.
    According to the affidavit of a DEA Diversion Investigator (DI), 
following Respondent's submission of his renewal application, DIs 
obtained from both local pharmacies and MAPS, information pertaining to 
the prescriptions issued by Respondent; the DIs also met with 
Respondent on February 11, 2009 to review his compliance with the MOA. 
GX 22, at 4-5.
    During the February 11, 2009 meeting, Respondent provided the DIs 
with his controlled-substance prescription log. Id. at 5. The log 
showed that Respondent had issued prescriptions to several patients 
with ``as many as five refills'' for Androgel, a schedule III 
controlled substance, as well as that he had issued prescriptions with 
between

[[Page 16837]]

three and seven refills, to multiple patients for Testim, another 
schedule III controlled substance. Id.; see also GXs 7, 9-11, 13. The 
evidence also showed that Respondent had issued a prescription for 
Ativan (lorazepam), a schedule IV controlled substance, with three 
refills, to two different patients. See GX 7.
    Based on their review of MAPS data and medical records, the DIs 
further determined that on December 21, 2007, Respondent had issued a 
prescription for hydrocodone/acetaminophen, a schedule III controlled 
substance to M.L.G., a resident of Florida; that on January 8, 2008, he 
had issued a prescription for propoxyphene/acetaminophen, a schedule IV 
controlled substance, to M.S.E., a resident of Colorado; and that on 
July 25 and August 18, 2008, he had issued prescriptions for 60 and 90 
tablets of alprazolam, a schedule IV controlled substance, to B.P., a 
resident of Port Orange, Florida. GX 22, at 6. The DIs further 
determined that on September 24, 2007, Respondent prescribed 160 
tablets of phenobarbital, a schedule IV controlled substance, to his 
wife, by calling in a prescription to a local pharmacy. Id. at 7; see 
also GX 16. Moreover, during the February 11, 2009 meeting with the 
DIs, Respondent denied calling in the prescription for his wife and 
maintained ``that he called in a refill of an earlier phenobarbital 
prescription issued by'' another physician (Dr. C.) on September 21, 
2007. GX 22, at 7. However, the prescription issued by Dr. C. was for 
only sixteen tablets with two refills. Id.
    In addition, the DIs compared the MAPS report showing Respondent's 
prescribing with the controlled-substance log he was required to 
maintain. Id. at 8. This review showed that Respondent had failed to 
document fourteen prescriptions in the log. Id. Upon reviewing the 
patient charts, the DIs also found various instances in which 
Respondent had prescribed controlled substances to a patient for more 
than six months and had not maintained a MAPS report in the patient's 
chart. Id. at 9.
    Finally, on November 3, 2008, the Michigan Board of Ostheopathic 
Medicine and Surgery issued an administrative complaint to Respondent 
charging him with eight counts of violating state law, including five 
counts of ``prescribing drugs without a lawful diagnostic or 
therapeutic purpose.'' GX 18, at 5-12; 19 (citing Mich. Comp. Laws 
Sec.  16221(c)(iv)). The Board also charged Respondent with negligence 
and incompetence based on his prescribing of Suboxone to treat opioid 
dependence without having ``obtain[ed] the necessary certification.'' 
Id. at 18-19 (citing Mich. Comp. Laws Sec. Sec.  16221(a) and 
16221(b)(i)). While the Board sought to impose sanctions on 
Respondent's medical license,\1\ see id. at 1-3, Respondent did not 
notify DEA of the proceeding.\2\ GX 22, at 10.
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    \1\ Respondent received the complaint on November 8, 2008. See 
GX 19 (letter from Respondent to Michigan Bureau of Health 
Professions).
    \2\ In its Request for Final Agency Action, the Government also 
contends that Respondent altered the expiration date of his 
registration when he submitted his credentials to a health insurance 
company. The Government did not, however, establish that it provided 
notice to Respondent of its intent to rely on this conduct in this 
proceeding.
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Discussion

    Section 304(a) of the CSA 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). In determining the public interest, 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.

21 U.S.C. 823(f).
    ``[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 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 (D.C. Cir. 2005).\3\
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    \3\ The Government has ``the burden of proving that the 
requirements for * * * revocation or suspension pursuant to section 
304(a) * * * are satisfied.'' 21 CFR 1301.44(e); see also 21 CFR 
1301.44(d) (Government has ``the burden of proving that the 
requirement for [a] registration pursuant to section 303 * * * are 
not satisfied''). In a contested hearing, where the Government 
satisfies its prima facie burden, the burden then shifts to the 
registrant to demonstrate why he can be entrusted with a new 
registration. Medicine Shoppe-Jonesborough, 73 FR 363, 380 (2008).
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    In this matter, I conclude that the record establishes that 
Respondent has violated multiple provisions of the MOA and that these 
violations are relevant under factors two and five. The record also 
establishes that Respondent made a false statement to DEA Investigators 
when he denied having issued a controlled substance prescription to his 
wife. This conduct is also relevant under factor five. I therefore 
conclude that Respondent has committed acts which render his 
registration inconsistent with the public interest and that these acts 
are sufficiently egregious to warrant the revocation of his 
registration.\4\
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    \4\ With respect to factor one, while the Investigative Record 
contains a copy of the Administrative Complaint filed by the 
Michigan Board, there is no evidence establishing the outcome of 
this proceeding. However, even assuming that Respondent retains his 
state authority, DEA has long held that while the possession of 
state authority is an essential condition for holding a 
Practitioner's registration, see 21 U.S.C. 823(f), this factor is 
not dispositive in the public interest inquiry. Patrick Stodola, 74 
FR 20727, 20730 n.16 (2009).
     Likewise, there is no evidence that Respondent has been 
convicted of a criminal offense under either Federal or State law 
related to the distribution or dispensing of a controlled substance 
(factor three). However, because there are multiple reasons why a 
person may not even be charged, let alone be convicted of such an 
offense, DEA has long held that this factor is not dispositive. See 
Edmund Chein, 72 FR 6580, 6593 n.22 (2007).
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Factors Two and Five--Respondent's Experience in Dispensing Controlled 
Substances and Such Other Conduct Which May Threaten Public Health and 
Safety

    In May of 2007, DEA exercised forbearance and allowed Respondent to 
settle a previous Show Cause proceeding by entering into an MOA. 
However, as found above, Respondent promptly proceeded to violate 
multiple provisions of the MOA.
    First, Respondent violated the MOA's restriction that he could only 
prescribe a thirty-day supply of a controlled substance with one 
refill, and that he could issue a new prescription only after the 
patient visited him. More specifically, the record shows that 
Respondent issued prescriptions which authorized multiple refills to 
multiple patients for both schedule III anabolic steroids (Androgel and 
Testim) and a schedule IV depressant (lorazepam).
    Second, Respondent violated the MOA's provision that he could not 
prescribe a controlled substance to a non-resident of Michigan. More 
specifically, Respondent prescribed hydrocodone/acetaminophen, a 
schedule III controlled substance, to

[[Page 16838]]

M.L.G., a resident of Florida; he prescribed propoxyphene and 
acetaminophen, a schedule IV controlled substance, to M.S.E., a 
resident of Colorado; and on two occasions, he prescribed alprazolam, a 
schedule IV controlled substance to B.P., a resident of Florida.
    Third, Respondent violated the MOA's prohibition against his 
prescribing to a member of his immediate family. More specifically, on 
September 24, 2007, Respondent prescribed 160 tablets of phenobarbital, 
a schedule IV controlled substance, to his wife. Moreover, when 
questioned by the DIs regarding the prescription, Respondent denied 
having called in the prescription and asserted that he had only called 
in a refill of an earlier prescription which had been written by 
another physician. Respondent's statement was false because the other 
physician had authorized refills for only sixteen tablets, and it was 
materially false because the MOA prohibited him from prescribing to a 
family member and was thus capable of influencing the decision of the 
Agency as to whether to seek the revocation of his registration. See 
David A. Hoxie, M.D., 69 FR 51477, 51479 (2004) (considering false 
statements to investigators under factor five).
    Fourth, Respondent violated the MOA's requirement that he maintain 
a log of all controlled-substance prescriptions he issued. More 
specifically, Respondent failed to document fourteen controlled-
substance prescriptions in the log.
    Finally, Respondent violated the MOA's requirement that he notify 
DEA, in writing, within twenty days, of ``the initiation of any action 
by a state entity to * * * suspend, revoke, or otherwise limit [his] 
authority to handle controlled substances.'' Notwithstanding that the 
State filed an Administrative Complaint against him, which sought to 
impose sanctions on his medical license and his authority to handle 
controlled substances, see Mich. Comp. Laws Sec.  333.7311(6), 
Respondent failed to notify DEA that the proceeding had been brought.
    DEA has long held that a registrant's failure to comply with the 
terms of an MOA can constitute acts which render his registration 
inconsistent with the public interest. See Fredal Pharmacy, 55 FR 
53592, 53593 (1990) (holding that pharmacy which violated MOA ``ha[d] 
engaged in conduct which threatens the public health and safety''). 
This is so even if the violation of the MOA does not establish a 
violation of the CSA or its implementing regulations. Moreover, 
Respondent's various violations of the MOA, as well as his having made 
a false statement to the Investigators, show that he cannot be trusted 
to faithfully comply with the obligations of a registrant. I therefore 
conclude that Respondent's registration should be revoked and his 
pending application should be denied.

Order

    Pursuant to the authority vested in me by 21 U.S.C. 823(f) & 
824(a)(4), as well as by 28 CFR 0.100(b) & 0.104, I order that DEA 
Certificate of Registration, AF9086415, issued to Erwin E. Feldman, 
D.O., be, and it hereby is, revoked. I further order that any 
application of Erwin E. Feldman, D.O., to renew or modify such 
registration, be, and it hereby is, denied. This Order is effective 
April 25, 2011.

    Dated: March 10, 2011.
Michele M. Leonhart,
Administrator.
[FR Doc. 2011-7047 Filed 3-24-11; 8:45 am]
BILLING CODE 4410-09-P