[Federal Register Volume 61, Number 146 (Monday, July 29, 1996)]
[Notices]
[Pages 39469-39471]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-19197]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration
[Docket No. 94-83]


David M. Headley, M.D., Grant of Restricted Registration

    On September 7, 1994, the Deputy Assistant Administrator, Office of 
Diversion Control, Drug Enforcement Administration (DEA), issued an 
Order to Show Cause to David M. Headley, M.D., (Respondent) of Port 
Gibson, Mississippi, 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), as being inconsistent with the 
public interest.
    On September 30, 1994, the Respondent filed a timely request for a 
hearing, and following prehearing procedures, a hearing was held in 
Jackson, Mississippi, on August 22 and 23, 1995, before Administrative 
Law Judge Paul A. Tenney. At the hearing, both parties called witnesses 
to testify and introduced documentary evidence, and after the hearing, 
counsel for both sides submitted proposed findings of fact, conclusions 
of law and argument. On November 28, 1995, Judge Tenney issued his 
Findings of Fact, Conclusions of Law, and Recommended Ruling, 
recommending that the Respondent's application for registration be 
granted provided he meet the following conditions:

    (1) Submit to random, unannounced urine screenings once every 
two weeks for a period of not more than one year. Respondent shall 
transmit to the Special Agent in Charge of the New Orleans Field 
Division of the DEA or his designee the results of such urine 
screenings on a monthly basis.
    (2) Respondent shall continue to attend weekly Alcoholics 
Anonymous meetings, or other support group meetings of his choice, 
for a period of not less than one year.

Neither party filed exceptions to his decision, and on January 16, 
1996, Judge Tenney transmitted the record of these proceedings to the 
Deputy Administrator.
    The Deputy administrator has considered the record in its entirety, 
and pursuant to 21 C.F.R. 1316.67, hereby issues his final order based 
upon findings of fact and conclusions of law as hereinafter set forth. 
The Deputy Administrator adopts, in full, the Findings of Fact, 
Conclusions of Law, and Recommended Ruling of the Administrative Law 
Judge, and 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 on December 20, 1984, the 
Respondent voluntarily surrendered his DEA Certificate of Registration, 
AH9733862, upon admitting himself into the Ridgeview Institute in 
Smyrna, Georgia, for substance abuse treatment. From October 2, 1984, 
through February 4, 1987, the Respondent participated in a multi-phase 
rehabilitation treatment program. On February 20, 1986, the Mississippi 
State Board of Medical Licensure (Medical Board) granted the Respondent 
permission to re-register with the DEA in Schedules IV and V, and his 
DEA application was granted. The Respondent was issued a DEA 
Certificate of Registration, BH0570502, which was later modified to 
include Schedules III and IIIN.
    However, in 1988, the Respondent suffered a relapse, and he 
admitted that he was abusing controlled and non-controlled substances 
during this time. In August of 1988, Medical Board investigators 
reviewed prescription files at pharmacies in the Respondent's local 
area. The investigation revealed that the Respondent had prescribed and 
ordered numerous controlled and non-controlled substances for himself, 
and had prescribed controlled substances for his wife. As a result of 
this investigation, the Medical Board and the Respondent entered into a 
Consent Agreement on September 28, 1988, which prohibited the 
Respondent from administering, dispensing, or prescribing addictive 
drugs to himself or members of his family, and which required him to 
submit to random, unannounced drug screening tests.
    The Respondent submitted to the drug screens, and a test taken on 
April 28, 1989, indicated the presence of amphetamine and 
methamphetamine, both Schedule II drugs, and phendimetrazine, a 
Schedule III drug. Again on July 21, 1989, the Respondent's drug screen 
tested positive for amphetamine, and for phenobarbital, a Schedule IV 
drug. Consequently, the Medical Board served the Respondent with an 
Order of Prohibition dated August 11, 1989, prohibiting him from 
practicing medicine until such time as he was evaluated for chemical 
dependency.
    On August 16, 1989, the Respondent entered another treatment 
center, where he remained until September 15, 1989. On October 24, 
1989, the Respondent entered into a second consent agreement with the 
Medical Board, requiring him, among other things, (1) to surrender his 
DEA registration, (2) to refrain from administering, dispensing, or 
prescribing to himself or to family members, any drug having addiction-
forming qualities, (3) to submit to random, unannounced, and witnessed 
urine and/or blood screens for a period of at least five years (4) to 
complete all required phases of a drug abuse treatment program, and (5) 
to affiliate with the Mississippi State Medical Association Impaired 
Professionals Program. As of the time of the hearing before Judge 
Tenney, the Respondent had abided by, and was still subject to, the 
terms of this agreement, including the drug screening provision. On 
October 24, 1989, the Respondent surrendered his DEA registration as 
required by the second consent agreement.
    The Respondent continued his drug abuse rehabilitation program 
through February 27, 1990, completing Phase III of his treatment. He 
then entered into a two-year aftercare monitoring phase of recovery. On 
February 27, 1992, the Respondent voluntarily extended his aftercare 
contract for another year, after successfully having completed the 
required two-year period. The Respondent also successfully completed

[[Page 39470]]

his third year contract on February 26, 1993.
    Previously, on November 22, 1991, the Medical Board approved the 
Respondent's request for permission to register with the DEA to obtain 
a Certificate of Registration for Schedules IV and V only. Accordingly, 
on November 24, 1991, the Respondent applied for such a restricted 
registration, and on July 12, 1993, the Director, Office of Diversion 
Control of the DEA, issued an Order to show Cause to the Respondent, 
seeking to deny his application. The Respondent waived his right to a 
hearing, and on October 25, 1993, the then-Administrator of the DEA 
issued a Final Order denying the Respondent's application. The 
Administrator concluded that the investigative file and the 
Respondent's written statement with accompanying letters written on his 
behalf, had presented insufficient evidence that the Respondent had 
been sufficiently rehabilitated from his substance abuse problems to be 
entrusted with a DEA Certificate of Registration. Subsequently, on 
December 15, 1993, the Respondent reapplied for a DEA registration in 
Schedules IV and V, and it is that application that is the subject of 
this order.
    The evidence of record establishes that the Respondent has not 
abused controlled substances or alcohol since August 16, 1989. The 
Respondent recently earned his sixth-year sobriety chip from the local 
Alcoholics Anonymous (AA) chapter, and he continues to attend these 
group support meetings at least once a week.
    An investigator for the Medical Board testified before Judge 
Tenney, relaying the investigative results of the Respondent's relevant 
conduct from 1984 through 1992. He also stated that since August of 
1989, there had been no further complaints made to the Medical Board 
regarding the Respondent's drug abuse problem or his capabilities as a 
physician.
    Further, an expert in drug and alcohol abuse counseling (Counselor) 
testified that, based upon his personal knowledge of the Respondent and 
his professional relationship with him, the Respondent was fully 
rehabilitated. The Counselor also stated that he was a recovering drug 
addict and alcoholic, that he had attended AA meetings with the 
Respondent since 1990, and that he was the Respondent's sponsor. He 
testified that he had not observed anything that would indicate that 
the Respondent had, since his rehabilitation in 1989, used any alcohol 
or controlled substances. The Counselor also opined that the Respondent 
was not a risk for diverting controlled substances. Mr. David 
Whitehead, an expert in drug and alcohol abuse counseling with similar 
personal knowledge of the Respondent, also opined that the Respondent 
was fully rehabilitated and would not create a risk for diverting 
controlled substances.
    Further, Dr. Doyle Smith, a physician and an expert in addiction 
medicine, also testified. Based upon his personal knowledge of the 
Respondent's behavior, as well as his review of the evidence in this 
matter, Dr. Smith concluded that the Respondent was rehabilitated ``as 
successful[ly] as he can be in six years of ongoing sobriety.''
    Dr. Roy Barnes, the Chief of Staff of the Claiborne County 
Hospital, testified before Judge Tenney, stating that he was the 
primary care doctor for the Respondent and his wife, and thus he had 
frequent contact with both of them. Dr. Barnes testified that he had 
not observed any symptoms or behavior from the Respondent or Mrs. 
Headley that would lead him to believe that either of them had any 
substance abuse problems since returning from their treatment programs. 
Dr. Barnes also opined that the Respondent and his wife were fully 
rehabilitated.
    The administrator of the Claiborne County Hospital, Ms. Wanda 
Fleming, testified that the Respondent had regained all of his staff 
privileges at the hospital, to the extent possible without a DEA 
registration. She stated that the Respondent had been appointed Vice 
Chief-of-Staff for the hospital, and that there had been no 
deficiencies in his performance since his privileges had been 
reinstated. Ms. Fleming also testified that it was very difficult to 
find doctors to cover the emergency room at night, on weekends, and on 
holidays, but that she could always count on the Respondent to help 
when asked.
    The record also contains evidence that it is very difficult to get 
doctors to practice in Claiborne County, Mississippi, because the area 
is very rural and the people are poor. The county leads the State in 
infant mortality and teenage pregnancies, and the Respondent is one of 
only two doctors who deliver babies in the county.
    The Respondent's wife testified before Judge Tenney, describing her 
substance abuse problems, her successful completion of a drug abuse 
treatment program, her continuing attendance at a local support group, 
and to the fact that she had been sober since October 17, 1989. In 
addition, she testified that she and her husband have a strong 
marriage, that they provide support for one another, and that their 
support system included a large family and many close friends. She also 
stated that since their respective dates of sobriety, neither she nor 
her husband had diverted, misused, or abused controlled substances.
    Pursuant to 21 U.S.C. 823(f), the Deputy Administrator may deny an 
application for registration as a practitioner, if he determines that 
granting the registration would be inconsistent with the public 
interest. Section 823(f) requires 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, 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 or 
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., Docket No. 88-42, 54 FR 16422 
(1989).
    Absent any evidence of a conviction record, the Deputy 
Administrator finds that factors one, two, four, and five are relevant 
in determining whether the Respondent's registration would be 
inconsistent with the public interest. As to factor one, `` 
recommendation of the appropriate State licensing board,'' it is 
uncontroverted that the Respondent's past conduct resulted in the 
Medical Board's taking affirmative action to remove him from the 
practice of medicine and to prohibit him from administering, 
dispensing, or prescribing controlled substances. The two consent 
agreements and the prohibition order evidence such Medical Board 
intervention. However, also uncontroverted is the Medical Board's 
reinstatement of his medical license, and its order of November 22, 
1991, allowing the Respondent to apply for a DEA Certificate of 
Registration in Schedules IV and V. Thus, the Deputy Administrator 
finds that the Medical Board, upon receiving evidence of the 
Respondent's drug abuse condition, quickly responded to the situation. 
However, the Medical Board also acknowledges the Respondent's current 
condition of recovery and has reinstated

[[Page 39471]]

his medical licensure. Further, the Medical Board also supports the 
Respondent's application for registration in Schedules IV and V.
    As to factor two, the Respondent's ``experience in dispensing * * * 
controlled substances,'' and factor four, the Respondent's 
``[c]compliance with applicable State, Federal, or local laws relating 
to controlled substances,'' the Deputy Administrator agrees with Judge 
Tenney's conclusion, that the Respondent had prescribed controlled 
substances to himself and his wife for their personal use and for no 
legitimate medical reason. To be effective, a prescription for a 
controlled substance ``must be issued for a legitimate medical purpose 
by an individual practitioner acting in the usual course of his 
professional practice.'' 21 CFR 1306.04(a); see also Harlan J. 
Borcherding, D.O., 60 FR 28,796, 28,798 (1995). The Respondent's 
conduct failed to meet this standard.
    As to factor five, ``[s]uch other conduct which may threaten the 
public health or safety,'' the Deputy Administrator agrees with Judge 
Tenney's conclusion, that ``[t]here is no persuasive evidence that the 
Respondent's DEA registration would threaten the public health and 
safety.''
    The Deputy Administrator also finds significant that the Respondent 
and his wife have been in a state of recovery from their substance 
abuse condition since 1989. Further, the evidence demonstrates that, 
since the Respondent voluntarily surrendered his DEA Certificate of 
Registration in 1989, he has not prescribed nor dispensed controlled 
substances. The Respondent submitted voluminous evidence of negative 
drug screening results over a five-and-one-half year time frame. 
Finally, numerous witnesses with firsthand knowledge of the 
Respondent's and his wife's conduct since 1989 have testified to their 
continued sobriety and opined that a relapse after over five years of 
sobriety was highly unlikely. Such evidence supports the Respondent's 
position that granting him a DEA Certificate of Registration in 
Schedules IV and V would be in the public's interest.
    However, Judge Tenney also noted the Respondent's history of 
successful treatment in 1984 and a relapse in 1988. He concluded that,

due to the seriousness of Respondent's substance abuse problem in 
the past, it is prudent to continue to monitor Respondent's 
recovery. Dr. Moffitt, one of the founders of the Impaired 
Professional Program for doctors in Mississippi, testified that 
Respondent should be granted a DEA registration at this time, but 
that Respondent should also continue drug testing. I agree with that 
suggestion.

Consistent with his conclusion, Judge Tenney recommended that the 
Respondent be granted a DEA registration subject to two conditions. The 
Deputy Administrator agrees with Judge Tenney's conclusion, with some 
minor modification to the order. The Respondent will be required, 
beginning on the effective date of this order:
    (1) To submit on a monthly basis to the Special Agent in Charge of 
the New Orleans Field Division of the DEA or his designee, a copy of 
his urine screening results from urine screenings, (a) taken once every 
two weeks for a period of six months, and (b) subsequently taken once 
every month for a follow-on period of six months.
    (2) To continue to attend weekly Alcoholics Anonymous meetings, or 
other support group meetings of his choice, for a period of one year.
    Therefore, the Deputy Administrator finds that the public interest 
is best served by issuing a DEA Certificate of Registration in 
Schedules IV and V to the Respondent, subject to the above 
requirements.
    Accordingly, the Deputy Administrator of the Drug Enforcement 
Administration, pursuant to the authority vested in him by 21 U.S.C. 
823, and 28 CFR 0.100(b) and 0.104, hereby orders that the pending 
application of David M. Headley, M.D., for a DEA Certificate of 
Registration in Schedules IV and V be, and it hereby is, approved, 
subject to the above requirements.
    Further, the Respondent submitted extensive evidence demonstrating 
the need for the DEA Certificate of Registration in his current 
practice, as well as evidence of the community's need for a physician 
of his specialty with prescribing capabilities. Also, the Respondent 
presented evidence that he would be willing to comply with the ordered 
requirements as a condition to granting this registration. Thus, the 
Deputy Administrator has determined that the public interest will be 
better served in making this final order effective upon publication, 
rather than thirty days from the date of publication. Therefore, this 
order is effective upon the date of publication in the Federal 
Register.

    Dated: July 22, 1996.
Stephen H. Greene,
Deputy Administrator.
[FR Doc. 96-19197 Filed 7-26-96; 8:45 am]
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