[Federal Register: June 7, 2005 (Volume 70, Number 108)]
[Notices]
[Page 33203-33206]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07jn05-87]
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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]
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