Federal Register / Vol. 65, No. 24 / Friday, February 4, 2000 / Notices 5663

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 thenDeputy 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 thenActing 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).

5664 Federal Register / Vol. 65, No. 24 / Friday, February 4, 2000 / Notices

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 noncontrolled, non-sterodial, antiinflammatory 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 thenDeputy 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

Federal Register / Vol. 65, No. 24 / Friday, February 4, 2000 / Notices 5665

1The Government did not provide any evidence

of the statutory provisions relating to weight control

in existence prior to 1987.

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

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 96–10]

Wesley G. Harline, M.D.; Continuation

of Registration With Restrictions

On October 27, 1995, the Deputy

Assistant Administrator, Office of

Diversion Control, Drug Enforcement

Administration (DEA) issued an Order

to Show Cause to Wesley Harline, M.D.

(Respondent) of Ogden, Utah, notifying

him of an opportunity to show cause as

to why DEA should not revoke his DEA

Certificate of Registration AH1650248

and deny any pending applications for

renewal of such registration as a

practitioner pursuant to 21 U.S.C. 823(f)

and 824(a)(4), for reason that his

continued registration would be

inconsistent with the public interest.

By letter dated December 14, 1995,

Respondent, through counsel, filed a

request for a hearing, and following

prehearing procedures, a hearing was

held in Salt Lake City, Utah on April 1

through 3 and May 6 through 8, 1997,

and by telephone in Salt Lake City and

Arlington, Virginia, on August 18

through 21, 1997, 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 findings of fact,

conclusions of law and argument.

In his brief, Respondent’s counsel

included findings based upon evidence

that was not introduced at the hearing.

On January 5, 1998, the Government

filed a Motion to Strike Post Record

Evidence from Respondent’s Proposed

Findings of Fact, Conclusions of Law

and Argument. On January 21, 1998,

Respondent filed his Opposition to

Government’s Motion to Strike Post

Record Evidence, and in the alternative,

Motion to Reopen the Record.

On April 2, 1999, Judge Bittner issued

her Opinion and Recommended Ruling,

Findings of Fact, Conclusions of Law

and Decision (Opinion), granting the

Government’s motion to strike the

additional evidence, denying

Respondent’s motion to reopen the

record, and recommending that

Respondent’s DEA Certificate of

Registration be revoked and any

pending applications be denied. On

June 14, 1999, Respondent filed

exceptions to Judge Bittner’s Opinion

and on August 2, 1999, the Government

filed its response to Respondent’s

exceptions. Thereafter, on August 10,

1999, Judge Bittner transmitted the

record of these proceedings to the

Deputy Administrator.

While this matter was pending with

the Deputy Administrator, Respondent

submitted a letter dated November 4,

1999, responding to the Government’s

response to his exceptions and formally

moving that the record be reopened to

allow additional evidence to be

considered. As will be discussed more

fully below, the Deputy Administrator

denies Respondent’s motion to reopen

the record and has not considered

Respondent’s letter dated November 4,

1999, in rendering his decision in this

matter.

The Deputy Administrator has

considered the record in its entirety,

and pursuant to 21 CFR 1316.67, hereby

issues his final order based upon

findings of fact and conclusions of law

as hereinafter set forth. This final order

replaces and supersedes the final order

issued on December 9, 1999, and

published at 64 FR 72678 (December 28,

1999). The Deputy Administrator

adopts, except as specifically noted

below, the findings of fact set forth in

Judge Bittner’s Opinion, but does not

adopt Judge Bittner’s recommended

conclusions of law and decision.

The Deputy Administrator finds that

Respondent graduated from medical

school in 1945. In or about 1953,

Respondent joined a general surgery

practice in Ogden, Utah. He has been a

licensed physician in Utah since 1953

and has held state and Federal

authorizations to handle controlled

substances since approximately the time

he obtained his medical license.

According to Respondent, sometime in

the 1980s, he virtually terminated his

general surgery practice to concentrate

on cosmetic surgery. Respondent

testified that he considered weight

control to be a part of cosmetic surgery,

and as of 1997, he saw 15 to 20 weight

control patients every weekday and a

few weight control patients on

Saturdays.

Primarily at issue in this proceeding

is whether Respondent properly

prescribed controlled substances to his

weight control patients. Therefore,

provisions of Utah law relating to this

issue were placed into evidence. As of

1987 1, the Utah Administrative Code

(Administrative Code) authorized the

Utah Division of Occupational and

Professional Licensing (DOPL) to revoke

a State license to handle controlled

substances if the holder ‘‘[p]rescribes or

administers any controlled substance for

weight control for more than 30 days in

any 12 twelve-month period.’’ Utah

Admin. Code R153–38–8 (1987–1988).