[Federal Register Volume 62, Number 115 (Monday, June 16, 1997)]
[Notices]
[Pages 32658-32663]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-15641]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 95-43]
Dennis Robert Howard, M.D. Grant of Restricted Registration
On May 24, 1995, the Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement Administration (DEA), issued an
Order to Show Cause to Dennis Robert Howard, M.D., (Respondent) of
Macon, Georgia, notifying him of an opportunity to show cause as to why
DEA should not deny his applications for registration as a practitioner
under 21 U.S.C. 823(f), for reason that such registration would be
inconsistent with the public interest.
By letter dated June 21, 1995, Respondent, through counsel, timely
filed a request for a hearing, and following prehearing procedures, a
hearing was held in Atlanta, Georgia on April 23 and 24, 1996, before
Administrative Law Judge Mary Ellen Bittner. At the hearing, both
parties
[[Page 32659]]
called witnesses to testify and introduce documentary evidence. After
the hearing, both sides submitted proposed findings of fact,
conclusions of law and argument and reply briefs. On February 28, 1997,
Judge Bittner issued her Opinion and Recommended Ruling, Findings of
Fact, Conclusions of Law and Decision, recommending that Respondent be
granted a DEA Certificate of Registration subject to several
restrictions that would remain in effect for three years from the
issuance of the registration. On March 20, 1997, Government counsel
filed exceptions to the Recommended Ruling of the Administrative Law
Judge, and on April 7, 1997, Judge Bittner transmitted the record of
these proceedings to the Acting Deputy Administrator.
The Acting 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. The Acting Deputy Administrator adopts, except as specifically
noted, the findings of fact, conclusions of law, and recommended ruling
of the Administrative Law Judge. 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 Acting Deputy Administrator finds that Respondent received his
Doctor of Medicine degree from the University of Wisconsin in 1962. In
1983, he moved to Georgia and became licensed to practice medicine in
that state. He was served on the faculty of several universities and is
board-certified in family medicine. In addition, he has held offices in
various professional organizations, has served on numerous boards, and
has published several articles and portions of books. Respondent
testified that he treats many patients for chronic pain.
In November 1992, an agent for the Georgia Secretary of State, in
conjunction with DEA and the Georgia Drugs and Narcotics Agency,
investigated Respondent's prescribing practices. The investigation
included surveying prescriptions at local pharmacies, subpoenaing
medical records, and interviewing Respondent. The results of the
investigation were submitted to the Georgia Composite State Board of
Medical Examiners (Board), which then met on Novebmer 4 and 5, 1992,
and unanimously voted to ``issue an Emergency Suspension of
[Respondent's] DEA permit and cite for a Formal Hearing.'' It was not
until May 10, 1993, that the Board issued an Order of Summary
Suspension of Privileges for the Prescribing of Controlled Substances
and a Notice of Hearing. The Order specifically charged that
``Respondent has prescribed controlled substances in such a manner as
to constitute unprofessional conduct departing from or failing to
conform to the minimal standards of acceptable and prevailing medical
practice and prescribing for other than legitimate medical purpose. * *
*'' The Board ordered the Respondent surrender his DEA registration
within 48 hours of service of the Order.
On May 11, 1993, state agents went to Respondent's office to serve
the Board's Order. Initially, Respondent was not present, but came to
the office at the agents' request. One of the agents at the hearing
testified that when Respondent arrived at the office, he appeared to be
under the influence of some type of substance. Respondent testified
however that he was not under the influence of anything, but instead
was in shock over the Board's actions. An insurance biller who worked
with Respondent and was present on May 11th, testified that respondent
did not appear intoxicated or under the influence when she saw him at
the office that day.
Respondent indicated to the agents that he ordered drugs from a
wholesaler and then dispensed them to his patients so cost, rather than
issuing them prescriptions. He further stated that he had used various
controlled substances over the years and had smoke marijuana as
recently as three days before the interview, and that his marijuana use
was limited to three to four times a month. At the hearing in this
matter, Respondent testified that he took aspirin with codeine (Empirin
No. 4) twice a day for an ``irritable bowel problem'', and three or
four diazepam tablets a week for leg muscle spasm, and that both of
these drugs were originally prescribed for him by a physician.
Respondent also testified that he had self-prescribed hydrocodone with
APAP one to three times a week when he had back pain, and that he took
other non-controlled drugs for his back problems and his plood
pressure. Respondent further testified that he has not used marijuana
since 1993, he has only taken medications that were prescribed for him
by his physician.
Following service of the Board's Order, on May 12, 1993, the
Medical Coordinator for the Board advised Respondent that he must
undergo a 96 hour in-patient medical and psychological evaluation.
Thereafter, Respondent checked into an Atlanta hospital, and May 14,
1993, DEA personnel went to the hospital and requested that Respondent
surrender his DEA registration. Respondent signed the surrender of
registration form, but testified that the surrender was not truly
voluntary, since he felt pressured to sign because he was told that
``it would show my good faith in cooperating with this investigation
and that it would make it easier for me to get my DEA certification
back once I was cleared of the charges.''
On May 17, 1993, the Board issued an Order of Summary Suspension of
Medical License stating that it ``has received reliable information
that Respondent is unable to practice medicine with reasonable skill
and safety'' as a result of his admitted use of marijuana, diazepam,
aspirin with codeine and hydrocodone. At the hearing in this matter,
Respondent testified that during the summer of 1993, he was evaluated
by a psychiatrist and a family practitioner to determine whether or not
he was addicted or impaired. Both doctors found that Respondent was fit
to practice medicine.
A hearing began on August 9, 1993, regarding the Board's charges
against Respondent for the misprescribing of controlled substances.
During the hearing, it was discovered that Board personnel had provided
its expert witness with incomplete copies of Respondent's patient
records. Subsequently, the Board's counsel agreed not to advise the
expert, prior to his testimony, that the records were incomplete.
However, the Hearing Officer found that the Board's counsel did not
adhere to this agreement and therefore, the Hearing Officer dismissed
the Notice of Hearing, noting that ``submission of incomplete records
to the medical expert was patently unfair * * *.''
On August 10, 1993, the Superior Court of Fulton County ordered the
reinstatement of Respondent's license to practice medicine, finding
that the Board had not provided Respondent with a prompt hearing on the
charges which led to the suspension. Thereafter, on September 10, 1993,
the court ordered that Respondent's license to practice medicine remain
in effect until a final determination was made on his alleged
impairment Respondent testified that eventually the charges of
misprescribing were ``dropped'' by the Board.
On August 16, 1993, Respondent filed his first application for a
CEA Certificate of Registration that is the subject of these
proceedings. He affirmatively answered question 4(b) on the application
which asks if the applicant has ``ever been convicted of a crime in
connection with controlled substances
[[Page 32660]]
* * * or ever surrendered or had a Federal controlled substance
registration revoked, suspended, restricted or denied, or ever had a
State professional license or controlled substance registration
revoked, suspended, denied, restricted or placed on probation?'' In
explaining his answer, Respondent indicated that he had ``voluntarily
surrendered my controlled substances privileges on May 14, 1993 while
cooperating with an investigation * * *.'' Respondent did not mention
the Board's summary suspension orders.
Respondent testified that in the midst of the hearing in the fall
of 1993 regarding the allegations of his impairment, the Board entered
into settlement negotiations with Respondent. On January 6, 1994,
Respondent and the Board entered into a consent order reinstating his
license to practice medicine and his authority to prescribe controlled
substances. The consent order did not state that Respondent had
committed any offenses, which according to the testimony of an attorney
who had represented the Board and had served as a hearing officer for
the Board is unusual for a consent order because it did not contain an
``admission of any kind of allegations.'' The order directed that for
five years, Respondent would (1) ``Attend and successfully complete the
mini-residency'' on proper prescribing practices of controlled
substances within six months of the order; (2) allow the Medical
Coordinator to review and inspect his medical records; (3) ``abstain
from the consumption of all mood altering substances except as
prescribed by a duly licensed practitioner (other than Respondent) for
a legitimate medical purpose''; (4) allow the Board to order him to
submit to random urine, blood, fluid or hair analysis and/or a mental
or physical evaluation; (5) comply with diagnosis, treatment and record
keeping rules; (6) report any malpractice suits against him; (7) supply
a copy of the Consent Order to any person he was associated with in
practice; (8) not use a physician's assistant to perform any of the
restricted tasks; (9) notify the Medical Board if he leaves the state
for more than thirty days for the purpose practicing medicine; (10)
abide by all State and Federal laws regulating the practice of
medicine; and, (11) be evaluated by the Medical Board regarding his
compliance with the Order sixty days prior to its expiration.
On June 17, 1994, Respondent submitted a second application for a
DEA registration. He again affirmatively answered question 4(b), with
the following explanation: ``On May 14, 1993, I signed a Voluntary
Surrender for my previous DEA certification to cooperate with and
facilitate an investigation by the State of Georgia Composite Board of
Medical Examines into allegations of misprescribing. My licence [sic]
was reinstated on August 10, 1993, and all charges were subsequently
dropped * * *.'' Respondent testified that he did not mention the
consent order with the Board, because he did not believe that the term
``probation'' in question 4(b) applied to the consent order. The
consent order does not specifically state that Respondent's license was
placed on probation. The former Board attorney and hearing officer
testified that if the Board had intended to impose probation on
Respondent, it would have set ``it forth right at the beginning of the
order, you know, that a Respondent is placed on probation upon the
following terms and conditions * * *.''
On July 14, 1994, Respondent received DEA order forms for the
ordering of Schedule I and II controlled substances. These forms were
imprinted with a new DEA registration number. Respondent testified that
he believed that order forms could not be issued except to holders of a
valid registration number, and therefore he believed that his
application had been approved. When approximately a week had passed and
he had not received his Certificate of Registration, Respondent
telephone a DEA supervisory registration specialist on July 22, 1994,
and was told that the order forms had been issued in error, that his
DEA registration was not valid, and that he should return the order
forms. Respondent testified that he was told ``on the phone that it was
not good, but I figured if they had issued it, then there was a more
proper way that they could withdraw it.''
Respondent then telephoned a member of Senator Sam Nunn's staff,
asking for assistance in determining the validity of his DEA
registration. Respondent had been working with this staff member for a
number of months in trying to obtain a decision regarding his
application for DEA registration. The staff member contacted DEA on
July 25, 1994, and was told that Respondent did not possess a valid DEA
registration. The staff member then left a message for Respondent on
his answering machine on the evening of July 25th, but did not actually
speak with Respondent until the following morning. Respondent testified
that he had been hospitalized and was discharged on the 25th, but did
not go into his office where his answering machine was located until
the following day, and therefore did not get the message from the staff
member until July 26th.
A local pharmacist indicated to DEA that Respondent had telephoned
in a prescription for an individual for Tylenol with codeine No. 3 on
July 26, 1994, using the DEA number that was listed on the order forms.
Respondent and the individual testified that the individual had been
Respondent's patient from 1989 until 1992, when Respondent moved out of
town. Both testified that the individual had back problems, and that
she was under the care of a physician who was out of town when she
began experiencing back pain. They testified that she called Respondent
in the evening on July 25, 1994, requesting a prescription. Respondent
called the prescription in to a local pharmacy, but when a co-worker
went to pick up the medication, the pharmacist refused to fill the
prescription until the pharmacist could verify Respondent's DEA
registration number. The individual called Respondent later that
evening and Respondent offered to write a prescription for Tylenol with
codeine No. 3 for the individual that she could pick up the following
day at office.
Respondent testified that at the time that he wrote the
prescription for the individual on the morning of July 26, 1994, he had
not yet listened to the message from Senator Nunn's staff member,
stating that his DEA registration was invalid. Respondent testified
that after talking with the staff member later in the morning on July
26th, he ceased writing any controlled substance prescriptions.
The Government argues that Respondent's registration would be
inconsistent with the public interest because he twice issued a
prescription for a controlled substance to an individual even though he
knew that his DEA number was invalid; he used marijuana; he repeatedly
self-prescribed controlled substances; his medical license is currently
subject to the terms of a consent order; and he was less than truthful
in his explanation of his answers to question 4(b) on his applications
for registration. Respondent argues that his application should not be
denied because when he received the DEA order forms, he believed that
he had been issued a valid DEA registration number; that although a DEA
employee told him that the forms had been issued in error, he did not
believe the registration number was invalid until the Senator's staff
member instructed him not to use the number; and that he self-
prescribed controlled substances only for a legitimate medical purpose,
and now only takes medication
[[Page 32661]]
that is prescribed for him by his physician. Respondent admits that his
use of marijuana was illegal, but asserts that he stopped using it in
May 1993.
Pursuant to 21 U.S.C. Sec. 823(f), the Deputy Administrator may
deny an application for a DEA Certificate of Registration if he
determines that such registration would be inconsistent with the public
interest. In determining the public interest, the following factors are
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 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 be denied. See Henry J. Schwarz, Jr., M.D., Docket No. 88-
42, 54 FR 16,422 (1989).
Regarding factor one, it is undisputed that on May 10, 1993, the
Board summarily suspended Respondent's privileges for prescribing
controlled substances based upon allegations of misprescribing, and on
May 17, 1993, summarily suspended Respondent's license to practice
medicine based upon allegations of impairment. However, it is also
undisputed that ultimately there were no findings made by the Board or
admissions made by Respondent regarding these allegations. Respondent
did enter into a consent order with the Board on January 7, 1994. While
the consent order imposed certain requirements on Respondent, for the
most part, it merely restated powers that the Board already has by
virtue of its laws and regulations that apply to all physicians.
As to factors two and four, it is undisputed that Respondent issued
two prescriptions for Tylenol with codeine No. 3 while not registered
with DEA. The Government argues that Respondent had been verbally
informed by a DEA registration specialist several days before he issued
the prescriptions that he did not possess a valid registration.
Respondent argues that he thought that he was registered when he issued
the prescriptions because he had received DEA official order forms
indicating a new registration number, and that although he had been
orally advised by the registration specialist that his number was not
valid, he received no written notification to that effect.
Judge Bittner concluded that ``it would have been more prudent for
Respondent to verify his status before issuing any controlled substance
prescriptions. However, the agency's failure to notify Respondent in
writing that he did not have a valid DEA registration contributed to
the misunderstanding, and under these circumstances I cannot say that a
preponderance of the evidence establishes that Respondent did not act
in good faith in issuing these prescriptions.'' In her opinion, Judge
Bittner did not find that Respondent violated provisions of the
Controlled Substances Act by issuing controlled substance prescriptions
without a valid DEA registration. The Government filed exceptions to
Judge Bittner's conclusion arguing that there is no ``good faith ''
exemption from liability in administrative proceedings. The Acting
Deputy Administrator agrees with the Government. The Controlled
Substances Act and its implementing regulations require that a
physician possess a valid DEA registration in order to legally
prescribe controlled substances. See, 21 U.S.C. 822(a), and 21 CFR
1301.31(a) and 1306.03(a)(2). Respondent was not exempt from this
requirement when he issued the two prescriptions for Tylenol with
codeine No. 3 on July 25 and 26, 1994. However, as DEA has previously
held, if Respondent issued these prescriptions with the good faith
belief that he was properly registered with DEA, that certainly is a
mitigating factor in determining the public interest. See, Stanley Alan
Azen, M.D., FR 57,893 (1996).
Next the Government argues in its exceptions that ``to the extent
any purported `good faith' on the part of Respondent might be
considered as a mitigating factor in this proceeding, the Government
takes exception to the Administrative Law Judge's funding that a
preponderance of the evidence did not establish a lack of good faith on
the part of the Respondent in issuing the two prescriptions.'' The
Government argues that Respondent knew that he did not have a valid DEA
registration when he issued the prescriptions. The Acting Deputy
Administrator concludes that Respondent's belief that he was validly
registered with DEA when he issued the prescriptions is not
unreasonable. Respondent received DEA official order forms that
indicated a new DEA registration. While as a result of his inquiry, he
was verbally told by a DEA registration specialist that he did not
possess a valid registration, he never received anything in writing
from DEA notifying him of this fact, and he had no idea whether the
individual he spoke to was in a position to declare a registration
invalid. Like Judge Bittner, the Acting Deputy Administrator notes that
it probably would have been more prudent for Respondent to not issue
any prescriptions until he received clarification from Senator Nunn's
staff member. However, upon learning from the staff member that he was
not properly registered, Respondent ceased issuing controlled substance
prescriptions.
The Acting Deputy Administrator concludes that while Respondent
issued two controlled substance prescriptions when he was not
authorized to do so, this is not so egregious as to warrant the denial
of his application for registration. The prescriptions were issued to a
former patient who suffered from back pain and whose regular physician
was out of town. In addition, Respondent possessed a good faith belief
that he was in fact properly registered with DEA.
As to Respondent's other experience in dispensing controlled
substances and compliance with applicable laws and regulations,
Respondent admitted that he self-prescribed various controlled
substances which is a violation of the Board's rules and regulations.
Respondent admitted that he self-prescribed hydrocodone with APAP for
back pain. He also admitted to taking aspirin with codeine for an
irritable bowel and diazepam for leg spasms, but that these drugs were
originally prescribed for him by his physician. Judge Bittner found
that while Respondent's self-prescribing was in violation of state
rules and regulations, Respondent ceased this practice over three years
before the hearing in this matter, there is no evidence that he is
likely to resume the practice, and there is no evidence contrary to
Respondent's testimony that he now only takes medications prescribed to
him by another physician.
The Government argued in its exceptions that Respondent in fact
violated state rules and regulations by self-prescribing controlled
substances; that the fact that he has not self-prescribed in over three
years ``should be considered only in the context of a mitigating
factor''; and that the Administrative Law Judge failed to consider that
Respondent ceased self-prescribing only after his state medical license
and controlled substance
[[Page 32662]]
privileges were summarily suspended and he had surrendered his previous
DEA registration. The Acting Deputy Administrator concludes that
Respondent violated state rules and regulations by self-prescribing
controlled substances. The Acting Deputy Administrator notes that it is
quite possible that the only reason that Respondent has ceased self-
prescribing is because he does not have the authority to prescribe
controlled substances. However, with proper restrictions placed on his
registration, the Acting Deputy Administrator agrees with Judge Bittner
that such conduct is not likely to recur. At least two of the drugs
that Respondent had self-prescribed were originally prescribed by
another physician. There is no evidence in the record that any of the
drugs were taken for other than a legitimate medical purpose. Also,
there is no evidence that Respondent has since taken any medication
that was not prescribed for him by another physician. Finally, two
physicians independently evaluated Respondent and determined that he
was not impaired.
The Acting Deputy Administrator also concludes that Respondent's
admitted use of marijuana violated both state and Federal law. As the
Government noted, Respondent's use of marijuana was not restricted to a
one-time activity. In May 1993, Respondent admitted to smoking
marijuana three to four times a month. The Acting Deputy Administrator
is extremely troubled by his behavior. However, Respondent testified
that he has not smoked marijuana since May 1993, and there is no
evidence in the record to the contrary.
Regarding factor three, Respondent has not been convicted of any
violations of Federal or state laws relating to the manufacture,
distribution or dispensing of controlled substances.
As to factor five, the Government argues that Respondent has been
misleading, or at least less than candid, by failing to completely
explain his affirmative response to question 4(b) on his applications.
He failed to state that his state medical license and controlled
substance privileges had been suspended or that he was subject to a
consent order. Like Judge Bittner, the acting Deputy Administrator
finds Respondent's incomplete explanation troubling. In responding to
the questions on an application, truthful answers and complete
disclosure are necessary for DEA to be able to adequately evaluate
whether it is in the public interest to issue a registration. However,
given the circumstances in this case, Respondent's failure to provide a
complete explanation on the applications does not warrant denial of the
applications. Respondent did in fact answer the question affirmatively,
and DEA was well aware of the state suspensions since that was the
basis for seeking Respondent's voluntary surrender of his DEA
registration. In addition, it is understandable that Respondent did not
believe that the consent order placed him on probation within the
meaning of the phrase in the application. An earlier draft of the
consent order included probationary language but the final version did
not contain such language. The former Board attorney and hearing
officer testified that if the Board intended to place Respondent on
probation, the consent order would have specifically so stated.
The Administrative Law Judge concluded that the Government had not
met its burden of proving by a preponderance of the evidence that
Respondent's registration would be inconsistent with the public
interest. Nonetheless, Judge Bittner stated that she is ``troubled by
Respondent's attitude towards regulation and [has] some question as to
whether he appreciates the responsibility that accompanies a DEA
registration.'' Accordingly, Judge Bittner recommended that
Respondent's application be granted subject to the following
restrictions to remain in effect for three years after Respondent's
Certificate of Registration is issued:
(1) Respondent must agree to periodic inspections of his records
based on a Notice of Inspection rather than an Administrative
Inspection Warrant.
(2) Respondent is prohibited from self-administering or self-
prescribing controlled substances under any circumstances.
(3) Respondent shall maintain a log of all controlled substance
prescriptions that he issues and shall send the log quarterly to the
local DEA Special Agent in Charge or his or her designee.
(4) Respondent shall not maintain any controlled substances in his
office.
The Government filed exceptions to Judge Bittner's recommended
ruling arguing that the Government established, at the very least, a
prima facie case under 21 U.S.C. 823(f)(2), (4) and (5), and that the
record as a whole supports the denial of Respondent's applications for
registration as inconsistent with the public interest. The Acting
Deputy Administrator agrees with the Government that it established a
prima facie case for denial of Respondent's applications. Respondent
issued prescriptions for controlled substances while not properly
registered with DEA. He self-prescribed controlled substances in
violation of state rules and regulations. Up until May 1993, he smoked
marijuana three to four times a month. He is currently subject to a
consent order with the Board. Finally, he did not give complete
explanations on his applications for registration.
However, the Acting Deputy Administrator concludes that in light of
the previously discussed mitigating circumstances present in this case,
denial of Respondent's applications is not warranted. The Acting Deputy
Administrator agrees with Judge Bittner that some restrictions on
Respondent's registration are appropriate in light of Respondent's
previous violations of Federal and state laws and regulations relating
to controlled substances. Therefore,the Acting Deputy Administrator
concludes that Respondent should be granted a DEA Certificate of
Registration subject to the following conditions for three years from
the date of issuance of the registration:
(1) Respondent must agree to periodic inspections by DEA personnel
based on a Notice of Inspection rather than an Administrative
Inspection Warrant.
(2) Respondent shall not dispense or prescribe controlled
substances to himself, and shall only administer to himself those
controlled substances legitimately dispensed or prescribed to him by
another duly authorized practitioner.
(3) Respondent shall not order or maintain any controlled
substances for his practice. He shall only prescribe controlled
substances and shall not administer or dispense any controlled
substances.
(4) Respondent shall maintain a log of all controlled substances
that he prescribes, and shall send the log quarterly to the Special
Agent in Charge of the nearest DEA office or his designee. The log
shall include, the name of the patient, the date that the controlled
substance was prescribed, and the name, dosage and quantity of the
controlled substance prescribed. If no controlled substances are
prescribed during a given quarter, Respondent shall indicate that fact
in writing, in lieu of submission of the log.
Accordingly, the Acting 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 a DEA Certificate of Registration submitted by
Dennis Robert Howard, M.D., be, and it hereby is granted, subject to
the above described restrictions. This order is effective July 16,
1997.
[[Page 32663]]
Dated: June 5, 1997.
James S. Milford,
Acting Deputy Administrator.
[FR Doc. 97-15641 Filed 6-13-97; 8:45 am]
BILLING CODE 4410-09-M