[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]
=======================================================================
-----------------------------------------------------------------------
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]
BILLING CODE 4410-09-M
