[Federal Register Volume 65, Number 24 (Friday, February 4, 2000)]
[Notices]
[Pages 5663-5665]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-2539]



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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 99-11]


Robert M. Golden, M.D.; Grant of Restricted Registration

    On January 22, 1999, the Deputy Assistant Administrator, Office of 
Diversion Control, Drug Enforcement Administration (DEA), issued an 
Order to Show Cause to Robert M. Golden, M.D. (Respondent) of 
Alpharetta, GA, notifying him of an opportunity to show cause as to why 
DEA should not deny his application for registration as a practitioner 
under 21 U.S.C. 823(f), for reason that this registration would be 
inconsistent with the public interest.
    By letter dated February 2, 1999, Respondent requested a hearing, 
and following prehearing procedures, a hearing was held in Atlanta, GA 
on June 9, 1999, before Administrative Law Judge Mary Ellen Bittner. At 
the hearing, both parties called witnesses to testify and introduced 
documentary evidence. After the hearing, both parties submitted 
proposed finding of fact, conclusions of law and argument. On November 
23, 1999, Judge Bittner issued her Opinion and Recommended Ruling, 
Findings, of Fact, Conclusions of Law and Decision (Opinion), 
recommending that Respondent's application for a DEA Certificate of 
Registration be granted in Schedules IV and V subject to several 
conditions. Neither party filed exceptions to Judge Bittner's Opinion 
and on December 23, 1999, she transmitted the record of these 
proceedings to the Office of the Deputy Administrator.
    The Deputy Administrator has considered the record in its entirety, 
and pursuant to 21 CFR 1316.67, hereby issues his final order based 
upon finding of fact and conclusions of law as hereinafter set forth. 
The Deputy Administrator adopts, the Opinion and Recommended Ruling, 
Findings of Fact, Conclusions of Law and Decision of the Administrative 
Law Judge, with slight modifications to the recommended decision as 
noted below. His adoption is in no manner diminished by any recitation 
of facts, issues and conclusions herein, or of any failure to mention a 
matter of fact or law.
    The Deputy Administrator finds that Respondent previously possessed 
DEA Certificate of Registration AG6243125. On May 25, 1994, an Order to 
Show Cause was issued proposing to revoke that Certificate of 
Registration and alleging that Respondent's continued registration 
would be inconsistent with the public interest. Following a hearing 
before Administrative Law Judge Paul A. Tenney, the then-Deputy 
Administrator revoked Respondent's DEA registration effective June 17, 
1996. See Robert M. Golden, M.D., 61 FR 24808 (May 16, 1996).
    In that prior proceeding, the then-Deputy Administrator found that 
in April 1987, Respondent entered into a Consent Order with the Georgia 
State Board of Medical Examiners (Board) based upon allegations of 
recordkeeping violations, the prescribing or dispensing of controlled 
substances while not acting in the usual course of professional 
practice, and the prescribing or ordering of controlled substances for 
an illegitimate medical purpose, Respondent's medical license was 
placed on probation for four years, and he was prohibited from 
prescribing, administering or dispensing Schedule II and III controlled 
substances, except in an institutional setting; required, for at least 
one year, to personally maintain a log of all Schedule IV controlled 
substances that he prescribed, administered or dispensed in his office; 
and required to attend at least 100 hours of continuing medical 
education focusing on drug abuse and/or pharmacology. The Consent Order 
specified that it was ``not an admission of wrongdoing for any purpose 
other than resolving the matters pending before the Board.''
    In addition in the prior proceeding, the then-Deputy Administrator 
found that in 1992 a confidential informant received prescriptions for 
Xanax, a Schedule IV controlled substance, from Respondent who issued 
the prescriptions using names other than that of the informant. Also, 
on two occasions in 1992, Respondent issued prescriptions for Xanax to 
an undercover police officer for no legitimate medical purpose. 
Further, Respondent increased the dosage strength of the controlled 
substances prescribed based upon the patient's demands rather than on 
his own medical judgment.
    In his final order revoking Respondent's previous DEA Certificate 
of Registration, the then-Deputy Administrator found that Respondent's 
conduct ``demonstrate[s] a cavalier behavior regarding controlled 
substances''; and that ``Respondent did not acknowledge any possibility 
of questionable conduct in his prescribing practices.'' The then-Deputy 
Administrator found that he ``was provided no basis to conclude that 
Respondent would lawfully handle controlled substances in the future.''
    On April 4, 1996, Respondent entered into another Consent Order 
with the Board wherein the Board contended that following the 
termination of Respondent's earlier probation in 1991, he ``prescribed 
and otherwise distributed controlled and/or dangerous substances 
without adequate medical justification.'' Respondent's license was 
placed on probation for a least four years and he was required to 
relinquish his right to prescribe, administer, dispense, order or 
possess Schedule I, II, IIN, III and IIIN controlled substances, as 
well as specifically named drugs to include the Schedule IV controlled 
substances Xanax and Stadol, and their generic equivalents. In addition 
pursuant to this Consent Order, Respondent is required to utilize 
triplicate prescriptions for all controlled substances prescribed by 
him; to maintain a contemporaneous log of his handling of controlled 
substances; and to successfully complete a specific continuing medical 
education course regarding the appropriate prescribing of controlled 
substances, as well as other continuing medical education.
    On June 15, 1997, Respondent submitted an application for a new DEA 
Certificate of Registration. On January 9, 1998, DEA issued an Order to 
Show Cause proposing to deny this application and alleging that 
Respondent's registration would be inconsistent with the public 
interest. Respondent did not reply to the Order to Show Cause, and 
consequently the then-Acting Deputy Administrator deemed that 
Respondent had waived his right to a hearing. On July 10, 1998, the 
then-Acting Deputy Administrator issued a final order denying 
Respondent's application for registration effective August 17, 1998. 
See 63 FR 38669 (July 17, 1998).
    In his final order denying Respondent's application, the then-
Acting Deputy Administrator found that the circumstances had not 
changed sufficiently from the revocation of Respondent's previous DEA 
registration to warrant granting Respondent's application.
    On October 12, 1998, Respondent submitted an application for a new 
DEA registration in Schedules II through V. Subsequently, Respondent's 
application was amended to seek registration in Schedules IV and V 
only. That application is the subject of these proceedings.
    The Deputy Administrator concludes that the then-Deputy 
Administrator's findings in the 1996 final order revoking Respondent's 
previous DEA Certificate of Registration are res judicata since they 
were made following an evidentiary hearing. See Stanley Alan Azen, 
M.D., 61 FR 57893 (1996).

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However, since the then-Acting Deputy Administrator's findings in the 
1998 final order denying Respondent's previous application for 
registration were based on the investigative file and following an 
evidentiary hearing, res judicata does not apply and therefore, 
Respondent is not precluded from litigating the matters at issue in the 
1998 proceeding.
    Accordingly, the Deputy Administrator concludes that the critical 
consideration in this proceeding is whether the circumstances, which 
existed at the time of the 1996 revocation of Respondent's previous DEA 
Certificate of Registration, have changed sufficiently to support a 
conclusion that Respondent's registration with DEA would be in the 
public interest.
    As discussed previously, Respondent is subject to a Consent Order 
with the Board until at least April 4, 2000. A DEA investigator 
testified at the hearing in this matter that Respondent has been in 
compliance with the terms of this Consent Order.
    Respondent testified that he has been practicing medicine for 
approximately 20 years, and for most of that time he practiced general 
or family medicine. In or about 1995, he realized that he was not 
suited for that type of medical practice and changed his specialization 
to cosmetic surgery. Specifically, Respondent specializes in tumescent 
liposuction where the cosmetic surgeon uses local rather than general 
anesthesia during the procedure.
    Respondent testified that in his current practice he needs to use 
Schedule IV and V controlled substances to effectively treat his 
patients. According to Respondent and his medical assistant, some 
patients have a heightened sense of anxiety that is not relieved by 
non-controlled sedatives. Respondent testified that if needed, he 
prefers to use Valium to help patients with anxiety pre-operatively, 
intra-operatively, and post-operatively. According to Respondent and 
literature in evidence, patients who undergo tumescent liposuction 
surgery experience minimal post-operative pain, and therefore do not 
need narcotic pain relievers. In those situations where a patient has 
needed some type of pain relief, Respondent has prescribed a non-
controlled, non-sterodial, anti-inflammatory analgesic.
    Respondent introduced evidence of his completion of a course in the 
proper handling of controlled substances. He testified that in the 
future, he is ``going to practice very defensive medicine.'' According 
to Respondent, ``[t]the old Dr. Robert Golden is dead and buried as far 
as I'm concerned.''
    Pursuant to 21 U.S.C. 823(f), the Deputy Administrator may deny an 
application for a DEA Certificate of Registration, if he determines 
that the registration would be inconsistent with the public interest. 
Section 823(f) requires that the following factors be considered in 
determining the public interest:
    (1) The recommendation of the appropriate State licensing board or 
professional disciplinary authority.
    (2) The applicant's experience in dispensing, or conducting 
research with respect to 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.
    These factors are to be considered in the disjunctive; the Deputy 
Administrator may rely on any one or a combination of factors and may 
give each factor the weight he deems appropriate in determining whether 
a registration should be revoked or an application for registration 
denied. See Henry J. Schwarz, Jr., M.D., 54 FR 16422 (1989).
    Regarding factor one, it is undisputed that until at least April 4, 
2000, Respondent is subject to the terms of a Consent Order entered 
into with the Board. Pursuant to this Consent Order, Respondent is 
limited to handling Schedule IV and V controlled substances only and is 
further precluded from handling the Schedule IV controlled substances 
Xanax and Stadol, and their generic equivalents.
    As to factors two and four, the then-Deputy Administrator found in 
the 1996 final order revoking Respondent's previous DEA Certificate of 
Registration that prior to 1993 Respondent prescribed controlled 
substances knowing that a person other than the one named on the 
prescription was the intended recipient of the controlled substances in 
violation of 21 CFR 1306.05, and that Respondent increased the strength 
of the medication prescribed based on the patient's request rather than 
using his professional medical judgment. The then-Deputy Administrator 
concluded that these prescriptions were not issued for a legitimate 
medical purpose in violation of 21 CFR 1306.04.
    The Deputy Administrator finds that there was no evidence presented 
in this proceeding to warrant a finding that Respondent has improperly 
handled controlled substances since 1993. The Consent Order with the 
Board dated April 4, 1996, alleges that Respondent prescribed and 
otherwise distributed controlled and/or dangerous substances without 
adequate medical justification. However, the Consent Order also 
indicates that Respondent denies these allegations and no evidence of 
the underlying facts of these allegations was introduced by the 
Government at this hearing.
    As to factor three, there is no evidence that Respondent has ever 
been convicted under State or Federal laws relating to controlled 
substances. Further, the record contains no evidence of other conduct 
that may threaten the public health and safety that would be considered 
under factor five.
    Judge Bittner noted that Respondent's last application for 
registration was denied because he had not presented sufficient 
evidence to indicate that his registration with DEA would be in the 
public interest. However, she concluded that Respondent has now 
presented such evidence. Judge Bittner noted that ``Respondent has 
completed a six day seminar in the appropriate prescribing of 
controlled substances, he is in compliance with the Board's 1996 
Consent Order, and he has changed his practice to a specialty in which 
the use of controlled substances is limited to very specific purposes 
and for specific periods of time.''
    Judge Bittner found Respondent's testimony to be credible and 
concluded that Respondent ``now understands and accepts the 
responsibility inherent in a DEA registration.'' Therefore, she 
recommended that Respondent be issued a DEA registration limited to 
Schedule IV and V, with the exception of Xanax and Stadol, subject to 
the following conditions:
    1. Respondent shall maintain accurate records showing all 
purchases, administering, and dispensing (including prescribing) of all 
controlled substances; and
    2. Respondent shall submit copies of all such records to the 
Special Agent in Charge of the DEA's Atlanta office, or his designee, 
quarterly, for two years from the effective date of his registration.
    The Deputy Administrator finds that the Government has established 
a prima facie case for denial of Respondent's application for 
registration. However, like Judge Bittner, the Deputy Administrator 
concludes that it would not be in public interest to deny Respondent's 
application, but rather to register him on a very limited a basis to 
give him the opportunity to demonstrate

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that he can responsibly handle controlled substances.
    Therefore, the Deputy Administrator concludes that Respondent 
should be issued a DEA Certificate of Registration in Schedules IV and 
V subject to the following restrictions for three years from the date 
of issuance of the DEA Certificate of Registration:
    (1) While Respondent will be registered in Schedule IV, he shall 
not prescribe, dispense, administer, order or otherwise handle Xanax, 
Stadol, or their generic equivalents.
    (2) Respondent shall send copies of records documenting all of his 
purchases of controlled substances to the Special Agent in Charge of 
the DEA Atlanta office, or his designee, on a quarterly basis.
    (3) Respondent shall submit, on a quarterly basis, a log of all of 
the controlled substances he has prescribed, administered, or dispensed 
during the previous quarter, to the Special Agent in charge of the DEA 
Atlanta office, or his designee. The log shall include: the patient's 
name; the date that the controlled substance was prescribed, 
administered or dispensed; and the name, dosage and quantity of the 
controlled substance prescribed, administered or dispensed. If no 
controlled substances are prescribed, administered or dispensed during 
a given quarter, Respondent shall indicate that fact in writing in lieu 
of submission of the log.
    (4) Respondent shall consent to random, unannounced inspections by 
DEA without requiring an Administrative Inspection Warrant.
    Accordingly, the Deputy Administrator of the Drug Enforcement 
Administration, pursuant to the authority vested in him by 21 U.S.C. 
823 and 824 and 28 CFR 0.100(b) and 0.104, hereby orders that the 
application for registration submitted Robert M. Golden, M.D., be, and 
it hereby is, granted in Schedules IV and V, subject to the above 
described restrictions. This order is effective upon the issuance of 
the DEA Certificate of Registration, but no later than March 6, 2000.

    Dated: January 18, 2000.
Donnie R. Marshall,
Deputy Administrator.
[FR Doc. 00-2539 Filed 2-3-00; 8:45 am]
BILLING CODE 4410-09-M