[Federal Register Volume 70, Number 108 (Tuesday, June 7, 2005)]
[Notices]
[Pages 33203-33206]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-11248]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 02-28]


Felix K. Prakasam, M.D. Revocation of Registration

    On February 6, 2002, the Deputy Assistant Administrator, Office of 
Diversion Control, Drug Enforcement Administration (DEA), issued an 
Order to Show Cause to Felix K. Prakasam, M.D. (Respondent) notifying 
Respondent of an opportunity to show cause as to why DEA should not 
revoke his DEA Certificates of Registration BP3420344 and BP44160029, 
pursuant to 21 U.S.C. 824(a)(1) and (a)(4) on the grounds he had 
materially falsified four DEA renewal applications and that his 
continued registration would be inconsistent with the public interest, 
as that term is used in 21 U.S.C. 823(f) and 824(a)(4). The Order to 
Show Cause also proposed that any pending applications for renewal 
should be denied under 21 U.S.C. 823(f).
    The Order to Show Cause alleged, in sum, that during 1995-1996, 
Respondent failed to maintain complete and accurate records of 
controlled substances dispensed at this medical offices located in 
Redlands and Salinas, California, and accountability audits during this 
period revealed overages and shortages of controlled substances at both 
registered locations. As a result, on March 10, 1997, after an informal 
administrative hearing at the DEA San Francisco office, Respondent 
entered into a Memorandum of Understanding with DEA in which he agreed 
to address the record-keeping violations and provide effective controls 
against theft and diversion of controlled substances.
    The Order to Show Cause further alleged that on April 30, 1997, the 
California Medical Board (California Board) brought on Accusation 
against Respondent's California medical license. As a result, on 
February 11, 1998, the California Board revoked Respondent's medical 
license, effective March 13, 1998. However, the Board stayed the 
revocation, placing Respondent's license on probation for three years, 
with conditions. On March 20, 2001, as a result of the California 
action, Respondent entered into a Consent Order with the Louisiana 
State Board of Medical Examiners (Louisiana Board) in which he agreed 
to an indefinite suspension of his Louisiana medical license.
    Finally, it was alleged that in February 1998 and February 2001, 
Respondent materially falsified a total of four applications for 
renewal of his DEA registrations by failing to disclose the California 
Board's action placing his medical license in a probationary status.
    Respondent requested a hearing on the issues raised by the Order to 
Show Cause and following pre-hearing procedures, a hearing was held in 
San Francisco, California, on March 12 and 13, 2003. At the hearing, 
both parties called witnesses to testify and introduced documentary 
evidence. After the hearing, both parties submitted proposed findings 
of fact, conclusions of law, and argument.
    On January 30, 2004, Presiding Administrative Law Judge Mary Ellen 
Bittner (Judge Bittner/ALJ) issued her Opinion and Recommended Ruling, 
Findings of Fact, Conclusions of Law and Decision of the Administrative 
Law Judge (Opinion and Recommended Ruling) in which she recommended 
that Respondent's two DEA registrations be revoked and any pending 
applications for renewal denied. No exceptions were submitted by the 
parties, and on March 2, 2004, Judge Bittner transmitted the record of 
these proceedings to the then-Acting Deputy Administrator of DEA.
    The Deputy Administrator has considered the record in its entirety 
and pursuant to 21 CFR 1316.67, hereby issues her final order based 
upon finding of fact and conclusions of law as hereinafter set forth.
    The Deputy Administrator adopts the findings of fact and 
recommendation of the Administrative Law Judge that Respondent's DEA 
Certificates of Registration be revoked.\1\
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    \1\ In an evidentiary/discovery ruling which did not impact 
relevant findings of fact or her recommendation for revocation, the 
ALJ concluded the Government should have provided Respondent copies 
of several DEA-6 Reports of Investigation which had been prepared by 
a DEA Diversion Investigator while investigating the allegations, 
several years before the hearing. Before testifying for the 
Government, the Diversion Investigator had used the reports to 
refresh his memory and Respondent's request for the documents was 
made after the Diversion Investigator completed testifying on direct 
examination. Notwithstanding the ALJ's ruling, the Government 
declined to provide Respondent the reports, contending they were not 
releasable under the rules and statutes governing DEA administrative 
hearings. Transcript, pages 168-169; Opinion and Recommended Ruling, 
page 5, fn. 1.
    The reports appear to be Jencks Act material (18 U.S.C. 3500) 
and the Deputy Administrator has previously ruled that ``pursuant to 
applicable law and regulations governing DEA administrative 
hearings, neither the principles of the Jencks decision nor the 
Jencks Act are applicable to these proceedings.'' See e.g., Branex 
Inc., 69 FR 8,682, 8,685 (2004) (Emphasis added) [Confirming 
predecessor Deputy Administrator's interlocutory decision that the 
Government is not required to supply a respondent at an 
administrative hearing, statements made and adopted by Government 
witnesses during their direct testimony.]
    Applying the principles of Branex and its predecessors, which 
addressed evidentiary/discovery standards applicable to DEA 
administrative hearing and detailed the Government's limited 
obligations to provide discovery before and during the course of 
hearings under the Administrative Procedures Act (5 U.S.C. 556(d)) 
and DEA regulations (21 CFR 1316.54-1316.59), the Deputy 
Administrator concludes the Government correctly declined to provide 
Respondent the reports in question here. See e.g., Nicholas A. 
Sychak, d.b.a. Medicap Pharmacy, 65 FR 75,959, 75,960-75,961 (2000) 
[No requirement for Government to disclose potentially exculpatory 
information to respondents in DEA administrative hearings]; Rosalind 
A. Cropper, M.D., 66 FR 41,040, 41,041 (2001) [``the Federal Rules 
of Evidence do not apply directly to these proceedings''].
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    The record before the Deputy Administrator shows Respondent 
received his medical degree in 1971 from Christian Medical College in 
Vellore, India. He interned and completed a residency in Maryland and 
in 1981 was licensed to practice in California. He also practiced 
medicine in Louisiana from an undetermined date until 1992, when he 
moved to California and opened a practice in Redlands. He eventually 
began working in the Salinas office of Rinaldo Fong, M.D. and took over 
that practice when Dr. Fong was deported. Respondent has held DEA 
Certificate of Registration BP3420344 for the Redlands location since 
November 18, 1992, and DEA resignation BP4416029 for the Salinas office 
since May 8, 1995. While Respondent is Board eligible in 
anesthesiology, his specialty at all relevant times has been bariatric 
medicine i.e., weight control.
    In July 1996, after reports were received of Respondent's possible 
purchase of excessive quantities of controlled substances, DEA 
Diversion Investigators, accompanied by an investigator from the 
California Board, conducted an inspection and accountability audit at 
Respondent's Salinas office. The inspection revealed Respondent had not 
complied with multiple regulatory requirements, including failures: (1) 
Maintain an inventory of controlled substances as of a specific date 
and as of the opening or closing of business; (2) maintain

[[Page 33204]]

addresses of patients to whom Respondent directly dispensed controlled 
substances or the initials or name of the dispenser; (3) adequately 
document a return of controlled substances to a supplier; (4) document 
a transfer of controlled substances between his Redlands and Salinas 
offices; and (5) retain a purchase invoice.
    An accountability audit performed in conjunction with the 
investigation in July 1996 indicated substantial overages of 
phentermine 30 mg. and 15 mg. and a substantial shortage of phentermine 
37.5. However, Judge Bittner concluded the overages were most likely 
attributable to the use of a zero opening inventory and did not 
necessarily indicate diversion.
    With regard to the shortage, there was a conflict in the evidence 
as to whether investigators had inventoried some 48,000 dosage units of 
phentermine 37.5 mg. which, if counted, would have resulted in an 
overage of that drug. A second inventory was performed at the Salinas 
Office on October 29 and 30, 1996, showing a substantial overage of 
phentermine 37.5 mg. and no significant shortages. Given the numbers, 
Judge Bittner concluded the second audit's overage indicated the 48,000 
units of phentermine 37.5 mg. had actually been on hand in July, but 
not counted in the first audit.
    The Deputy Administrator agrees with Judge Bittner that the record 
is inadequate to determine whether or not the July 1996 inventory was 
accurate. Therefore, it cannot be established whether or not Respondent 
was responsible for the shortage indicated by the first audit.
    On February 6, 1997, a Notice of Hearing was issued by DEA 
informing Respondent an informal hearing would be held in San Francisco 
on March 10, 1997. The notice alleged the record keeping and regulatory 
violations from the 1996 DEA investigations. Respondent appeared, 
represented by counsel, and testified regarding the reasons for the 
regulatory violations, but disputed the accuracy of the inventories.
    On May 8, 1997, Respondent executed a Memorandum of Understanding 
with DEA's San Francisco Field Division. In that Memorandum Respondent 
agreed to: (1) Comply with the provisions of the Controlled Substances 
Act and its implementing regulations at each of his registered 
locations; (2) take an inventory of controlled substances upon 
receiving a new DEA registration; (3) maintain dispensing logs that met 
regulatory requirements; (4) keep complete and accurate records; (5) 
keep required receiving records; (6) follow drug destruction procedures 
established by the DEA San Francisco office; and (7) provide effective 
controls against theft and diversion of controlled substances.
    The California Board conducted additional investigations of 
Respondent and on April 30, 1997, issued an Accusation against 
Respondent alleging multiple violations, including the matters from the 
1996 DEA inquiries. On February 11, 1998, the California Board issued a 
Decision, effective March 13, 1998, adopting a Stipulated Settlement 
and Decision (Stipulation) that Respondent and his then-attorney 
executed on January 5, 1998. In the Stipulation, Respondent waived 
various rights but did not admit engaging in any of the alleged 
misconduct.
    The Stipulation revoked Respondent's medical license and license to 
supervise physician assistants, but stayed the revocations and placed 
his licenses on probation for three years. Among its provisions, the 
Stipulation required Respondent to take continuing medical education 
courses and courses in prescribing practices and ethics, to maintain 
records of all controlled substances he prescribed, dispensed or 
administered, to make these records available for inspection, to take 
and pass an oral clinical examination, to have a third party present 
while examining or treating female patients and to comply with a 
probation surveillance program.
    The Stipulation provided that upon successful completion of 
probation, Respondent's California licenses would be reinstated. That, 
in fact, occurred and on May 11, 2001, Respondent was notified he had 
successfully completed probation. He has since been licensed to 
practice medicine in California without restriction. The evidence 
introduced at the DEA hearing indicates that since the 1996 DEA 
inquiry, he has complied with controlled substance record keeping 
requirements.
    Respondent was also licensed to practice medicine in Louisiana for 
a period of time prior to 1998, when his license expired. Under 
Louisiana law, he was entitled to renew the license for a period of 
four years from its expiration. On Februry 2, 2001, Respondent entered 
into a Consent Order with the Louisiana Board, in which the Board 
indefinitely suspended Respondent's entitlement to reinstatement of his 
Louisiana medical license. It further imposed, as a condition of 
eventual reinstatement, that Respondent successfully complete all 
probationary conditions levied by the California Board and obtain an 
unrestricted license to practice medicine in California. Respondent was 
also required to notify and appear before the Louisiana Board, prior to 
seeking renewal or reinstatement of his Louisiana license and he would 
accept any terms or conditions the Louisiana Board might impose as a 
condition of reinstatement.
    Respondent testified at the DEA hearing that when he signed the 
Memorandum of Understanding with DEA in May 1997, he understood ``that 
the matter would be laid to rest at that moment, and never again 
brought up; but it was not done so.'' He also testified he agreed to 
settle the California Board proceedings because he paid ``thousands of 
dollars'' in attorney fees and had no money left. However, he regretted 
that decision because he considered the allegations to be false. With 
regard to the Louisiana Consent Order, Respondent testified he signed 
it because he ``had not desire to go back to Louisiana.''
    On February 25 and 28, 1998, Respondent executed renewal 
applications for the DEA registrations at his Redlands and Salinas 
locations. On both applications, Respondent checked ``No'' in response 
to the question, ``Has the applicant even been convicted of a crime in 
connection with controlled substances under State or Federal law 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 or is any such 
action pending against the applicant?'' (Emphasis added). An applicant 
who responds affirmatively to this question is required to explain his 
answer on the back of the application. Respondent left this space blank 
on both applications.
    On February 27 and 28, 2001, Respondent again executed renewal 
applications for his Salinas and Redlands offices. These applications 
included the so-called ``liability questions'' pertaining to individual 
applicants. Question 3(d) asked, ``Has the applicant ever had a state 
professional license or controlled substance registration revoked, 
suspended, denied, restricted, or placed on probation?'' (Emphasis 
added). Respondent answered this question in the negative on both 
applications and left the space for explanations of affirmative answers 
blank.
    In June 2001, a Diversion Investigator from DEA's Riverside office 
looking into Respondent's February 2001 renewal applications, contacted 
the California Board and learned that Respondent's medical license for 
that state had been

[[Page 33205]]

placed on probation. In October 2001, the investigator wrote a report 
concluding Respondent had not truthfully answered the liability 
questions and recommend initiation of the instant Show Cause 
proceedings.
    Respondent testified at the DEA hearing that when he executed the 
two February 1998 applications, no discipline had yet taken effect 
against either his California or Louisiana medical licenses. When asked 
his understanding of the relevant question, Respondent replied he 
thought the question applied only to a separate state license to handle 
controlled substances, such as he had in Louisiana, and that no action 
had been taken against that license. He further testified he would have 
expected someone from DEA to contact him if there was a problem with 
the 1998 applications and that did not occur.
    On cross-examination, Respondent acknowledged that as of January 5, 
1998, he was aware he was entering into an agreement with the 
California Board which would result in his California medical license 
being placed on probation and that the questions on his February 1998 
applications referred to pending disciplinary actions, in addition to 
discipline already imposed. Nonetheless, when asked, ``isn't it true 
that, on February 25, 1998, you were aware that the California Medical 
Board was going to place [you] on probation?''--Respondent answered, 
``Yes, but that's not how I read that.'' Asked further what he thought 
the correct answer to the application's question was, Respondent 
replied, ``My opinion would be the correct answer is no.''
    Similarly, when asked whether the February 2, 2001, Consent Order 
with the Louisiana Board resulted in a suspension or probation of his 
Louisiana medical license, Respondent replied the Consent Order was 
based on the California settlement and he had agreed not to practice in 
Louisiana and not renewed his license in that state.
    With respect to the two 2001 DEA applications, Respondent testified 
his answers to question 3(d) were correct because the probationary 
period for his California medical license had run by that time and he 
thought the question referred to his controlled substance license, 
rather than his medical license.
    The Controlled Substances Act specifies in 21 U.S.C. 824(a)(1) that 
the Deputy Administrator may revoke a DEA Certificate of Registration 
if she finds the registrant has materially falsified any application 
for DEA registration. The Act also provides in section 824(a)(4) that 
the Deputy Administrator may revoke a registration if she determines 
the registrant has committed acts that would render his continued 
registration inconsistent with the public interest, as that term is 
determined under 21 U.S.C. 823(f). That section requires the following 
factors be considered in determining the public interest:
    (1) The recommendation of the appropriate state licensing board or 
professional disciplinary authority.
    (2) The applicant's experience in dispensing, or conducting 
research with respect to controlled substances.
    (3) The applicant's conviction record under Federal or State laws 
relating to the manufacture, distribution, or dispensing of controlled 
substances.
    (4) Compliance with applicable State, Federal, or local laws 
relating to controlled substances.
    (5) Such other conduct which may threaten the public health 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 she deems appropriate in determining 
whether a registration should be revoced or an application for 
registration denied. See Henry J. Schwartz, Jr., M.D., 54 FR 16,422 
(1989).
    With regard to the public interest factors, the Deputy 
Administrator finds, in agreement with Judge Bittner as to factor one, 
that Respondent has regained his unrestricted license to practice 
medicine in California and this weighs in favor of continued 
registration. However, inasmuch as State license is a necessary but not 
sufficient condition for DEA registration, this factor is not 
determinative. See Edson W. Redard, M.D., 65 FR 30,616, 30,619 (2000); 
James C. LaJevic, D.M.D., 64 FR 55,962, 55,964 (1999).
    As to factor two, Respondent's experience in handling controlled 
substances, Judge Bittner concluded that the recordkeeping deficiencies 
disclosed in the 1996 investigation indicated that continued 
registration would not be in the public interest. However, with regard 
to the 1996 audits, Judge Bittner concluded the evidence introduced at 
the DEA hearing was insufficient to show Respondent responsible for any 
shortages of controlled substances and thus weighed in favor of 
continued registration. The Deputy Administrator agrees with these 
conclusions.
    As to factor three, there is no evidence Respondent has ever been 
convicted of a crime relating to controlled substances.
    As to factor four, his compliance with applicable laws relating to 
controlled substances, Respondent's falsification of the renewal 
applications and the regulatory violations discussed above, establish 
he has not complied with the laws relating to controlled substances. 
The Deputy Administrator agrees with Judge Bittner that this factor 
weighs against continued registration.
    As to factor five, other conduct that may threaten the public 
health and safety, Judge Bittner noted that, although Respondent 
committed various regulatory violations prior to 1996, his subsequent 
recordkeeping apparently complied with DEA regulations. She therefore 
found this factor weighs in favor of continued registration. The Deputy 
Administrator agrees.
    In sum, Judge Bittner concluded Respondent corrected the 
recordkeeping deficiencies uncovered in 1996 and under the 
circumstances, the audit results did not warrant a finding that 
Respondent mishandled controlled substances during the period July 1995 
to October 1996. She concluded that the factors considered pursuant to 
21 U.S.C. 832(f), other than those relating to falsification of 
applications, did not establish that Respondent's continued 
registration was inconsistent with the public interest under 21 U.S.C. 
824(a)(4). The Deputy Administrator agrees revocation is unwarranted 
under that section.
    However, as Judge Bittner concluded, the issue of Respondent's 
falsification of renewal applications ``is another matter.'' DEA has 
previously held that in finding there has been a material falsification 
of an application, it must be determined the applicant knew or should 
have known that the response given to the liability question was false. 
See Merlin E. Shuck, D.V.M., 69 FR 22,566 (2004); James C. LaJavic, 
D.M.D., supra, 64 FR 55,962; Martha Hernandez, M.D., 62 FR 61,145 
(1997). In that regard, Judge Bittner found Respondent materially 
falsified four applications for renewal of his DEA registrations.
    The two 1998 applications did not refer only to licenses to handle 
controlled substances, but to ``a state professional license or 
controlled substance registration,'' and it is clear that applicants 
were required to report actions against their medical or other 
professional licenses, both completed and then-pending. Further, 
although the probation of Respondent's California license did not take 
effect until March 13, 1998, the disciplinary action was obviously 
pending on February 25 and 28, 1998, when Respondent executed his 
applications. Also, regarding the two February 2001 applications, at 
that time Respondent's California license had been on probation and the 
fact that the

[[Page 33206]]

probationary period was over did not justify a negative answer to the 
question, as it asked whether the applicant ``ever'' had discipline 
take against a state license.
    The Deputy Administrator also agrees with Judge Bittner's 
conclusions, made after observing Respondent's demeanor, that 
``Respondent's explanations for the misstatements and his continued 
insistence that his answers were correct are disingenuous at best'' and 
that he materially falsified the applications, which establishes 
grounds for revoking his registrations under 21 U.S.C. 824(a)(1).\2\
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    \2\ Respondent signed the Consent Order with the Louisiana Board 
on February 2, 2001, however it was not effective until March 20, 
2001. Judge Bittner noted that the 2001 DEA applications, which 
Respondent signed on February 27 and 28, 2001, did not specifically 
ask whether any disciplinary proceedings were then ``pending.'' 
Accordingly, she concluded that, ``at least arguably, Respondent was 
not required to disclose the Louisiana action inasmuch as it was not 
effective until March 20, 2001.'' While, given the wording of the 
application's questions, Respondent's omissions in failing to report 
this action may not have amounted to material misrepresentations 
under 21 USC 824(a)(1), it demonstrates his willingness to draw 
exceptionally fine lines in dealing with DEA regulators.
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    As Judge Bittner notes in her Opinion and Recommended Ruling, the 
governing statute is discretionary. See Mary Thomson, M.D. 65 FR 75,969 
(2000). In exercising discretion in determining the appropriate remedy 
in any given case, the Deputy Administrator considers all the facts and 
circumstances of the case. See Martha Hernandez, M.D., supra, 62 FR 
61,145.
    In recommending revocation of Respondent's registrations, Judge 
Bittner concluded,

    False statements on an application for DEA registration withhold 
from DEA information that is germane to the applicant's fitness to 
hold that registration. Kuen H. Chen, M.D., 58 FR 65401 (DEA 1993). 
Further, as discussed above, Respondent insisted that his answers to 
the questions on his 1998 and 2001 applications for renewal of his 
DEA registrations were accurate.
    They were not. In addition and also discussed above, 
Respondent's explanations of his answers on these applications were 
at best disingenuous. Respondent's cavalier attitude toward his 
responsibility to truthfully answer questions on the application 
raises serious concerns about whether he is willing to accept the 
other responsibilities inherent in a DEA registration.

    The Deputy Administrator has examined the record and finds the 
facts and credibility determinations of Judge Bittner to be well 
supported by the evidence. While the record does not establish that 
Respondent's continued registration would be inconsistent with the 
public interest, he materially falsified four applications for renewal 
of registration, which constitutes an independent ground for 
revocation.
    The Deputy Administrator shares Judge Bittner's concern regarding 
Respondent's on-going refusal or inability to acknowledge a 
registrant's responsibility to provide forthright and complete 
information to DEA, when required to do so as a matter of law or 
regulation. This attitude, reflected most recently in his testimony at 
the hearing under oath, does not auger well for his future compliance 
with the responsibilities of a registrant.
    Accordingly, the Deputy Administrator of the Drug Enforcement 
Administration, pursuant to the authority vested in her by 21 U.S.C. 
823 and 824 and 28 CFR 0.100(b), and 0.104, hereby orders the DEA 
Certificates of Registration BP3420344 and BP4416029, issued to Felix 
K. Prakasam, M.D., be, and hereby are, revoked. The Deputy 
Administrator further orders that any pending applications to renew or 
modify said registrations be denied. This order is effective July 7, 
2005.

    Dated: May 25, 2005.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. 05-11248 Filed 6-6-05; 8:45 am]
BILLING CODE 4410-09-M