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