[Federal Register Volume 63, Number 47 (Wednesday, March 11, 1998)]
[Notices]
[Pages 11907-11910]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-6158]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF JUSTICE

Drug Enforcement Administration
[Docket No. 97-15]


Cecil E. Oakes, Jr., M.D.; Grant of Restricted Registration

    On February 25, 1997, the Deputy Assistant Administrator, Office of 
Diversion Control, Drug Enforcement Administration (DEA), issued an 
Order to Show Cause to Cecil E. Oakes, Jr., M.D., (Respondent) of Fort 
Benning, Georgia and Fairfield, California, 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 April 1, 1997, Respondent, proceeding pro se, filed 
a request for a hearing and following prehearing procedures, a hearing 
was held in San Francisco, California on August 20, 1997, before 
Administrative Law Judge Gail A. Randall. At the hearing, the 
Government called witnesses to testify and introduced documentary 
evidence. Respondent testified on his own behalf. After the hearing, 
both sides submitted proposed findings of fact, conclusions of law and 
argument. On December 15, 1997, Judge Randall issued her Recommended 
Rulings, Findings of Fact, Conclusions of Law, and Decision, 
recommending

[[Page 11908]]

that Respondent be granted a DEA Certificate of Registration subject to 
several conditions. On January 2, 1998, Government counsel filed 
Exceptions to the Conclusion and Recommended Decision of the 
Administrative Law Judge, and on January 20, 1998, Judge Randall 
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 below, the Recommended Rulings, Findings of Fact, Conclusions of 
Law, and Decision 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 according to Respondent, 
he first obtained a DEA Certificate of Registration in the late 1960's. 
At some point, he became licensed to practice medicine in the state of 
Ohio and on December 29, 1987, was issued DEA Certificate of 
Registration AO9640168, for a Columbus, Ohio address bearing an 
expiration date of December 31, 1990. Respondent was not subsequently 
issued any other Certificates of Registration by DEA.
    Sometime in 1994, DEA was contacted by a credentials coordinator 
with the Department of the Army, regarding the status of Respondent's 
DEA Certificate of Registration. The credentials coordinator forwarded 
a copy of Respondent's credentials file to DEA. Upon reviewing the 
file, it became apparent that on three separate occasions, Respondent 
altered the last DEA Certificate of Registration issued to him. First, 
Respondent changed the date of issuance to December 29, 1988, with an 
expiration date of December 31, 1991. Then Respondent altered the 
issuance date to read December 29, 1990, and the expiration date to 
read December 31, 1993. Finally, Respondent altered the date of 
issuance to December 29, 1993, with an expiration date of December 31, 
1996. On this last altered certificate, Respondent also changed the 
address to a location in Tulsa, Oklahoma.
    Further investigation revealed that at various times between 1991 
and 1994, Respondent worked at two different army hospitals in Georgia. 
Documents supplied by the hospitals show that between January 1993 and 
January 1994, Respondent prescribed controlled substances to patients 
at one of the hospitals, and between June 16, 1994 and August 15, 1994, 
Respondent dispensed controlled substances to patients at the other 
hospital. Respondent did not possess a valid DEA Certificate of 
Registration during these time periods.
    During the course of the investigation, DEA discovered that 
Respondent worked for an employment agency for doctors that perform 
locum tenens work. DEA advised the agency that Respondent was not 
registered with DEA to handle controlled substances. Subsequently, on 
August 12, 1994, the employment agency sent a letter to Respondent 
asking for ``a statement attesting to the fact that you currently 
possess a current DEA registration and the current expiration date.'' 
Respondent replied, ``I have a current DEA registration. The expiration 
date is 1996.''
    Respondent then contacted DEA to arrange a meeting. When confronted 
with the altered Certificates of Registration, Respondent admitted that 
he knew that they were altered. Respondent was advised that he was not 
registered with DEA and therefore not authorized to handle controlled 
substances. Respondent was provided with an application for a new 
registration.
    DEA was advised by officials at Respondent's then-employer at Fort 
Benning that Respondent was a competent physician; that he was good at 
his job; and that they would continue employing Respondent. As a 
result, the DEA Atlanta office decided to register Respondent pursuant 
to a Memorandum of Agreement that would place certain restrictions on 
his DEA registration, including that he would abide by all laws and 
regulations relating to controlled substances; that he would admit that 
he handled controlled substances knowing that he did not have a current 
DEA registration; and that he would be restricted to the institutional 
use of his DEA registration at the hospital at Fort Benning. The terms 
of the agreement were to remain in effect for three years.
    Respondent signed the Memorandum of Agreement on November 4, 1995. 
The agreement was forwarded to the DEA Atlanta office by letter dated 
November 4, 1995, in which Respondent also requested that he be allowed 
to transfer his restricted registration from Fort Benning, Georgia to 
California. There is no evidence in the record regarding DEA's response 
to this request, however the DEA Atlanta Diversion Group Supervisor 
signed the agreement on behalf of DEA on November 15, 1995.
    In the midst of the Memorandum of Agreement being negotiated and 
executed, Respondent applied for a California medical license on August 
17, 1995. Thereafter, Respondent was issued a California medical 
license, however Respondent was subsequently cited and fined by the 
Medical Board of California for falsely representing his date of birth 
in both his application materials and to a medical board investigator.
    On June 14, 1996, Respondent submitted an application for a DEA 
Certificate of Registration at an address in California. Regarding this 
application, Respondent was not offered the opportunity to become 
registered subject to a Memorandum of Agreement, similar to the one 
executed by the DEA Atlanta office in 1995.
    Respondent testified at the hearing in this matter that at the time 
he altered his DEA Certificate of Registration, he was contending with 
the financial and emotional burdens that accompanied his son's 
diagnosis with Attention Deficit Disorder (ADD). His son attempted 
suicide on three occasions, he was in the process of divorcing his 
wife, and he had to file for bankruptcy. Respondent testified that, 
``in no way am I using (his son's problems) as an excuse for bad 
behavior or to try to rationalize it away unduly as being justified. 
But I also know within myself at least that this would never have 
happened if there hadn't been accumulating, seemingly never-ending 
pressures, stresses and all the impact that it had on me during those 
years.''
    Respondent asserted that his son's problems are now under control, 
and he ``can't think of any circumstance in which those actions would 
ever be repeated.'' Respondent testified that he had received 
counseling himself. Respondent recognized that there is no way that he 
can ever prove totally that his actions will not be repeated without 
having the opportunity to demonstrate that he can be trusted.
    Respondent is currently employed at a clinic in California that 
only treats patients with ADD. Respondent testified that there are only 
five specific controlled substances prescribed in the treatment of ADD 
at the clinic where he works, and no drugs are dispensed. Respondent 
further testified that he intends to only practice at this clinic. 
During the course of the hearing, Respondent indicated that he no 
longer wishes to be registered at the Georgia location listed on his 
September 1, 1994 application.
    The Founder and President of the Haight Ashbury Free Clinics, Inc. 
submitted a letter on Respondent's

[[Page 11909]]

behalf indicating that he had known and worked with Respondent for 25 
years. He stated that Respondent ``has high medical standards and a 
strong code of ethics. He has never abused drugs personally or over-
prescribed controlled substances with his patients * * *. I give him 
the highest recommendation.''
    As a preliminary matter, Judge Randall concluded that Respondent 
has indicated that he no longer wishes to be registered with DEA in 
Georgia. Accordingly, she recommended that Respondent be granted 
permission to withdraw his September 1, 1994 application pursuant to 21 
CFR 1301.16. The Acting Deputy Administrator agrees with Judge Randall 
that Respondent should be allowed to withdraw his application. However, 
Respondent still wishes to be registered with DEA to handle controlled 
substances in California.
    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 
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 the Medical Board of 
California cited and fined Respondent for falsely representing his date 
of birth both in his application materials for a California medical 
license and to a Medical Board investigator. However, there is no 
evidence in the record that Respondent's ability to practice medicine 
and handle controlled substances has been restricted in any way by the 
Medical Board.
    Factors two and four, Respondent's experience in dispensing 
controlled substances and his compliance with laws relating to 
controlled substances, are both relevant in determining whether 
Respondent's registration would be inconsistent with the public 
interest. The Acting Deputy Administrator finds that there is no 
question that Respondent has not been registered with DEA to handle 
controlled substances since December 31, 1990, yet he continued to use 
his expired DEA registration to prescribe and dispense those substances 
in violation of 21 U.S.C. 841(a)(1) and 843(a)(2).
    As to factor three, there is no evidence that Respondent has any 
convictions relating to the handling of controlled substances.
    Regarding factor five, Respondent's alteration of his DEA 
Certificate of Registration on three separate occasions and the 
misrepresentation of his date of birth on his application for a 
California medical license raise serious concerns regarding 
Respondent's trustworthiness. As Judge Randall found, ``these acts 
would justify denial of the Respondent's application for registration, 
for it calls into question the Respondent's truth and veracity, two 
traits the DEA must rely upon in its relationship with registrants.''
    Judge Randall concluded that the Government has presented a prima 
facie case for the denial of Respondent's application based upon the 
falsification of his DEA Certificate of Registration, his handling of 
controlled substances without proper authorization and his 
misrepresentations of his date of birth to the Medical Board of 
California. However, Judge Randall found it significant that even after 
knowing about Respondent's alterations of his DEA Certificate of 
Registration, DEA entered into a Memorandum of Agreement with 
Respondent concerning his application for registration in Georgia. 
Judge Randall further found ``it inconsistent that the DEA has since 
refused to offer a similar Memorandum for the Respondent's California 
practice,'' particularly since Respondent's handling of controlled 
substances in his practice in California would be more limited than 
what was proposed in Georgia. Judge Randall also found significant 
Respondent's expressions of remorse and his acceptance of 
responsibility for his serious mistakes, as well as, the letter from 
the Founder and President of the Haight Ashbury Free Clinics, Inc. who 
attested to Respondent's high medical and ethical standards.
    Judge Randall concluded that while Respondent's acts during 1991 to 
1994 warrant concern, the ``totality of the circumstances would justify 
a remedy less severe than total denial of the Respondent's 
application.'' Therefore, Judge Randall recommended that the 
``[g]ranting of a restricted registration, similar to the registration 
offered the Respondent in the 1995 Memorandum, would still protect the 
public interest.'' Judge Randall recommended that the following 
conditions be placed on Respondent's registration:

    1. For a period of three years from the effective date of the 
Deputy Administrator's final order, the Respondent provide the DEA 
San Francisco Field Division, information of the Respondent's change 
of employment, if any, thirty days prior to the effective date of 
the actual change of employment.
    2. For a period of three years from the effective date of the 
Deputy Administrator's final order, the Respondent file annually 
with the DEA San Francisco Field Division, evidence of his current 
California medical license.
    3. That the Respondent abide by all Federal, state and local 
laws and regulations relating to the registration to handle and the 
actual handling of controlled substances.

    The Government filed exceptions to Judge Randall's recommended 
decision. First, the Government seems to suggest that it is 
inconsistent for the Administrative Law Judge to find that the 
Government has presented a prima facie case for the denial of the 
application, yet recommend that Respondent be granted a restricted 
registration. The Acting Deputy Administrator finds that by definition, 
prima facie case means ``such as will prevail until contradicted and 
overcome by other evidence.'' Black's Law Dictionary (6th ed. 1990). 
Here, the Government has established that grounds exist to deny 
Respondent's application for registration given his alterations of his 
Certificate of Registration, his handling of controlled substances 
without proper authorization, and his misrepresentations to the Medical 
Board of California. However, the Acting Deputy Administrator concludes 
that the evidence in favor of denial of Respondent's application is 
overcome by the fact that he was not offered a Memorandum of Agreement 
similar to that offered in 1995, his expressions of remorse and 
acceptance of responsibility for his actions, and the letter of support 
submitted on his behalf. Therefore, the Acting Deputy Administrator 
does not find that Judge Randall's finding and recommendation are 
inconsistent.
    Second, the Government argues that Judge Randall's recommended 
action is a departure from prior agency practice and policy. The 
Government cites several cases where the applicant/

[[Page 11910]]

registrant ``engaged in conduct which was untruthful and lacking in 
trustworthiness and integrity,'' and DEA ``found that revocation was 
the appropriate sanction.'' However, the Acting Deputy Administrator 
finds that those cases can be distinguished from the facts and 
circumstances of this case. In those cases the registrant/applicant 
either continued to deny any wrongdoing or presented no evidence in 
mitigation. See Maxicare Pharmacy, 61 FR 27368; Stanley Karpo, D.P.M., 
61 FR 13,876 (1996); Albert L. Pulliam, M.D. 60 FR 54,513 (1995); 
Richard D. Close, M.D., 53 FR 43,947 (1988). The Government also cited 
Alra Laboratories, Inc. v. DEA, 54 F.3d 450 (7th Cir. 1995), for the 
proposition that ``past performance is the best predictor of future 
performance.'' The Acting Deputy Administrator finds that this case can 
also be distinguished from the present case, since the registration of 
a distributor was revoked based upon a long history of non-compliance 
with controlled substance laws and regulations.
    Next, the Government asserts that the 1995 Memorandum of Agreement 
entered into by the DEA Atlanta office was limited to a very 
restrictive set of circumstances and has no effect on the DEA 
Sacramento office's decision to seek an order proposing denial of 
Respondent's application for registration in California. The Government 
contends that the Atlanta Memorandum of Agreement limited Respondent to 
practice at a certain army hospital and did not extend to any other 
employment by Respondent. Additionally, Government counsel argues that 
it ``is aware of no policy or regulation which would require any DEA 
Field Division to accept or offer the same terms of registration as 
might have been offered from another DEA office * * *.''
    The Acting Deputy Administrator disagrees with the Government's 
suggestion that Respondent's access to controlled substances in Atlanta 
would have been more restricted than his access at his current place of 
employment in California. In Atlanta, he would have been working at 
only one army hospital, but he would have been working in the emergency 
room with access to a wide variety of controlled substances. In 
addition, his handling of controlled substances would not have been 
limited to prescribing only. At his present employment in California, 
Respondent has testified that he will only prescribe five specific 
controlled substances in his treatment of ADD patients.
    The Acting Deputy Administrator also disagrees with the 
Government's suggestion that it was improper for Judge Randall to find 
that it was inconsistent for the DEA Sacramento office not to offer 
Respondent the same restricted registration as was offered by the DEA 
Atlanta office in 1995. The Acting Deputy Administrator finds that the 
only difference in the facts surrounding Atlanta's decision to give 
Respondent a restricted registration and Sacramento's proposed denial 
of his application is that Respondent misrepresented his date of birth 
to the Medical Board of California. While this misrepresentation is 
troublesome, it does not warrant the denial of Respondent's application 
in light of his expressions of remorse and acceptance of responsibility 
for his actions. Therefore, the Acting Deputy Administrator finds it 
reasonable to register Respondent in California subject to certain 
terms and conditions.
    Finally, the Government argues in its exceptions that the 
conditions to be placed on Respondent's registration proposed by Judge 
Randall are of no benefit, since they are either already provided for 
in the regulations relating to the handling of controlled substances or 
they would merely provide DEA with advance notice of something that it 
would ultimately learn from the state. However, the Government did not 
offer any alternative restrictions.
    The Acting Deputy Administrator agrees with the Government that the 
proposed conditions recommended by Judge Randall are of limited 
benefit. Serious questions remain regarding Respondent's 
trustworthiness. But as Respondent testified, he will never be able to 
totally assure DEA that he can be trusted to responsibly handle 
controlled substances unless he is given an opportunity to prove 
himself with a restricted registration. Therefore, the Acting Deputy 
Administrator agrees with Judge Randall's recommendation to grant 
Respondent a restricted registration. Such a resolution will provide 
Respondent with the opportunity to demonstrate that he can responsibly 
handle controlled substances, while at the same time protect the public 
health and safety, by providing a mechanism for rapid detection of any 
improper activity. See Michael J. Septer, D.O., 61 FR 53762 (1996); 
Steven M. Gardner, M.D. 51 FR 12576 (1986). However, the Acting Deputy 
Administrator concludes that the terms and conditions of Respondent's 
registration recommended by Judge Randall must be modified as follows:

    1. By the effective date of this final order, Respondent shall 
notify the Resident Agent in Charge of the DEA Sacramento Resident 
Office, or his designee, of his place of employment at that time. 
Thereafter, for three years from the date of issuance of the DEA 
Certificate of Registration, Respondent shall immediately notify the 
Resident Agent in Charge of the DEA Sacramento Resident Office, or 
his designee, of any changes in his employment.
    2. For three years from the date of issuance of the DEA 
Certificate of Registration, Respondent's controlled substance 
handling authority shall be limited to the writing of prescriptions 
only for the five specific drugs identified by Respondent to be 
needed in his treatment of Attention Deficit Disorder patients: 
Ritalin, Dexedrine, Adderall, Desoxyn, all of which are Schedule II 
controlled substances, and Cylert, a Schedule IV controlled 
substance.
    3. For three years from the date of issuance of the DEA 
Certificate of Registration, Respondent shall maintain a log of all 
prescriptions that he issues. At a minimum, the log shall indicate 
the date that the prescription was written, the name of the patient 
for whom it was written, and the name and dosage of the controlled 
substance prescribed. Upon request of the Resident Agent in Charge 
of the Sacramento Resident Office, or his designee, Respondent shall 
submit or otherwise make available his prescription log for 
inspection.
    4. For three years from the date of issuance of the DEA 
Certificate of Registration, Respondent shall consent to periodic 
inspections by DEA personnel based on a Notice of Inspection rather 
than an Administrative Inspection Warrant.

    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 29 CFR 0.100(b) and 0.104, hereby orders that 
the application dated September 1, 1994, submitted by Cecil E. Oakes, 
Jr., M.D., be, and it hereby is, withdrawn. The Acting Deputy 
Administrator further orders that the application dated June 14, 1996, 
submitted by Cecil E. Oakes, Jr., M.D., be, and it hereby is, granted 
in Schedules II nonnarcotic and IV subject to the above described 
restrictions. This order is effective April 10, 1998.

    Dated: March 4, 1998.
Donnie R. Marshall,
Acting Deputy Administrator.
[FR Doc. 98-6158 Filed 3-10-98; 8:45 am]
BILLING CODE 4410-09-M