[Federal Register Volume 75, Number 157 (Monday, August 16, 2010)]
[Notices]
[Pages 49979-49991]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-20242]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 09-8]
Tony T. Bui, M.D.; Revocation of Registration
On September 15, 2008, the Deputy Assistant Administrator, Office
of Diversion Control, issued an Order to Show Cause to Tony T. Bui,
M.D. (Respondent), of Bedford, Texas. The Show Cause Order proposed the
revocation of Respondent's DEA Certificate of Registration, BB8997857,
which authorizes him to dispense controlled substances as a
practitioner, and the denial of any pending applications to renew or
modify his registration, on the ground that his ``continued
registration is inconsistent
[[Page 49980]]
with the public interest.'' ALJ Ex. 1, at 1 (citing 21 U.S.C. 823(f) &
824(a)(4)).
More specifically, the Show Cause Order alleged that Respondent has
``a history of cocaine abuse'' and that on, or about, December 13,
2007, the Texas Medical Board ordered Respondent to provide a urine
sample. Id. The Order alleged that the sample ``tested positive for
cocaine metabolites'' and that ``[a] retest of the same sample
reconfirmed'' this result. Id.
The Show Cause Order also alleged that Respondent has failed to
keep his registered address current with the Agency as required by 21
CFR 1301.51. Id. Next, the Show Cause Order alleged that Respondent was
``dispensing narcotic drugs for narcotic treatment without the
necessary authorization.'' Id. at 2 (citing 21 U.S.C. 823(g) and 21 CFR
101.13). Finally, the Show Cause Order alleged that Respondent had
``written prescriptions for Jintropin, a human growth hormone, which
the Food and Drug Administration has not approved for use in the United
States.'' Id.
Respondent's request for a hearing was not received by Agency until
October 29, 2008, and was thus beyond the thirty-day period for
requesting a hearing. See 21 CFR 1301.43(a). Respondent's counsel
explained that he had sent the request on October 14, but that one of
his staff had typed an incomplete address on the envelope which was
used for mailing the request, and that as a result, the mailing was
returned. ALJ Ex. 11, at 1. Respondent's counsel promptly refiled the
hearing request. ALJ Ex. 2. Finding that the Government had not
objected to Respondent's hearing request, and reasoning that ``the law
seeks to avoid a result where a blameless party suffers because of the
errors or neglect of his attorney,'' the ALJ concluded that Respondent
had shown ``good cause'' for his untimely filing. ALJ Ex.12, at 1-2;
see also 21 CFR 1301.43(d).
Following pre-hearing procedures, the ALJ conducted a hearing in
Dallas, Texas on August 4-5, 2009. At the hearing, both parties
elicited testimony and submitted various documents for the record.
Thereafter, both parties filed briefs containing their proposed
findings of fact, conclusions of law, and arguments.
On September 16, 2009, the ALJ issued his recommended decision
(hereinafter, also ALJ). Therein, the ALJ concluded that the Government
had proved that ``Respondent ha[d] committed acts that are inconsistent
with the public interest.'' ALJ at 37. The ALJ further concluded that
``Respondent has not accepted responsibility for his actions, expressed
remorse for his conduct at any level, or presented evidence that could
reasonably support a finding that'' his registration should be
continued. Id.
With respect to factor one--the recommendation of the state
licensing board--the ALJ noted that ``Respondent has had a somewhat
storied history with the Texas Medical Board'' and that ``[t]here has
been a repeated pattern of the Board meting out sanctions that are
followed by additional misconduct,'' but that the Board ``has
authorized the Respondent to continue to practice medicine.'' Id. at
23-34. However, based on the extensive precedent which holds that the
Agency has an ``independent responsibility to determine whether a
registration is in the public interest,'' and that possessing ``a state
license is a necessary, but not a sufficient condition for
registration,'' the ALJ concluded that while Respondent is currently
authorized to practice medicine in Texas, this factor ``does not weigh
for or against a determination as to whether [the] continuation of [his
registration] is consistent with the public interest.'' Id. at 24.
The ALJ then turned to factor three--Respondent's conviction record
for offenses relating to the manufacture, distribution and dispensing
of controlled substances. While noting that Respondent had been
indicted and received a deferred adjudication under Texas law for the
felony offense of possession of a controlled substance, the ALJ, after
noting the confused state of agency precedent, concluded that his
offense did not implicate this factor because it was not an offense
which ``relat[es] to the manufacturing, distribution, or dispensing of
controlled substances.'' Id. at 25. Thus, the ALJ held that ``this
factor does not weigh against * * * Respondent.'' Id. at 26.
Next, the ALJ considered together factors two (Respondent's
experience in dispensing controlled substances), four (compliance with
applicable laws related to controlled substances) and five (such other
conduct which may threaten public health and safety). With respect to
Respondent's prescribing practices, the ALJ concluded that the
Government had not proven that Respondent violated Federal law by
prescribing narcotic controlled substances for maintenance or
detoxification purposes. Id. at 29.
With respect to Respondent's prescribing of human growth hormone
including Jintropin, a substance which has not been approved by the
Food and Drug Administration for any medical indication, the ALJ
acknowledged that ``human growth hormone is not a controlled substance
with the meaning of the'' Controlled Substances Act and that
``Respondent's issuance of a prescription for the substance for
purposes other than FDA-approved uses does not fall squarely within the
purview of the criminal statute.'' Id. at 30. The ALJ reasoned,
however, that ``because he issued prescriptions for human growth
hormone for unauthorized uses and for Jintropin for any use, he
violated federal law by issuing prescriptions outside the usual course
of professional practice.'' Id. (citing 21 CFR 1306.04(a)). The ALJ
also concluded that this conduct was relevant under factor five,
reasoning that ``[i]t would be difficult to conceive of a scenario that
hits closer to the mark of a dangerous prescribing practice than the
prescribing of substances for purposes that have not been approved by
the FDA and the prescribing of a substance not approved for any purpose
by the FDA.'' Id. at 31.
Next, the ALJ considered the evidence pertaining to Respondent's
use of cocaine and alcohol. The ALJ noted that within two months of his
entering into an agreed order with the Texas Medical Board, which
required him to undergo treatment and urinalysis, Respondent used
cocaine and then ``fabricated a tale about innocent ingestion'' and
``procured a false letter from a former girlfriend admitting to a soft-
drink adulteration that never occurred.'' Id. at 32. Moreover, even
after the Texas Board restored his license (following a suspension),
Respondent failed to check in for testing and then tested positive for
alcohol, a result he claimed was caused by his use of an
antiperspirant. Id. The ALJ further noted that while the Texas Board
gave him ``yet another chance,'' Respondent subsequently tested
positive for cocaine. Id. The ALJ further found that ``Respondent has
met every objective indication of his continued substance abuse issues
with denials and fabrications.'' Id. at 32-33.
Noting the ``settled Agency precedent that a registrant's
continuing substance abuse and/or unsuccessful rehabilitation efforts
are contrary to the public safety and militate against entrusting such
a person with the responsibilities attendant upon a registration,'' the
ALJ concluded that because ``Respondent is not being currently
monitored for substance abuse, there is no way to accurately gauge
whether he has subsequently taken definitive, successful steps to
overcome his substance abuse issues * * * [and] [t]he evidence
regarding the continued episodes of cocaine use weighs in favor of
revocation.'' Id. at 33.
The ALJ also observed that Respondent had changed his practice
[[Page 49981]]
address at least four different times without updating his registered
location. Id. at 34 (citing 21 CFR 1301.12(a) & (b)(3)). While noting
that ``the nature of his practice at each practice address was not
demonstrated with crystal clarity at the hearing,'' the ALJ concluded
that the record showed that Respondent had administered testosterone
injections to at least one person at an unregistered address. Id. at
34. Moreover, the ALJ noted that Respondent was apparently no longer
practicing at the address listed on his renewal application and thus
his renewal application could be denied on this basis alone. Id. at 35.
The ALJ also did not find persuasive Respondent's explanation that he
had failed to update his addresses because ``he had difficulty
remembering to fulfill this obligation.'' Id. at 36. The ALJ thus
concluded that factors two, four, and five ``weigh strongly in favor of
revocation'' of Respondent's registration. Id.
The ALJ thus held that ``Respondent has committed acts that are
inconsistent with the public interest.'' Id. at 37. Moreover, the ALJ
found that ``Respondent has not accepted responsibility for his
actions, expressed remorse for his conduct at any level, or presented
evidence that could reasonably support a finding that'' he can be
entrusted with a registration. Id. The ALJ thus recommended that
Respondent's registration be revoked and any pending applications be
denied. Id.
Thereafter, Respondent filed exceptions to the ALJ's recommended
decision. More specifically, Respondent excepted to the ALJ's finding
that he had ingested cocaine in the days before his positive urine
test, contending that the ALJ had disregarded several significant
inconsistencies in the testimony of the Government's expert regarding
the sensitivity of hair testing. Resp. Exceptions at 1-3. Respondent
also maintained that an Agency Investigator had violated his right to
procedural due process when she told Respondent that he could not
prescribe controlled substances until further notice from the Agency.
Id. at 3-4. Finally, Respondent excepted to the ALJ's recommendation
that his registration be revoked, contending that he provided
``sufficient mitigating evidence'' to support his being granted ``a
restricted registration.'' Id. at 5.\1\
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\1\ Respondent also excepted to the ALJ's finding that the
Diversion Investigator who investigated him was not biased. Id. at
3.
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On October 13, 2009, the record was forwarded to me for Final
Agency Action. Having considered the entire record, I hereby issue this
Decision and Final Order. I agree with the ALJ that the Government has
not proved that Respondent prescribed methadone for maintenance or
detoxification purposes in violation of 21 U.S.C. 823(g), and that
substantial evidence supports the conclusion that Respondent ingested
cocaine in December 2007. I reject the ALJ's conclusion that
Respondent's prescribing of human growth hormone (including Jintropin)
violated 21 CFR 1306.04(a), and further hold that the allegation is
beyond the Agency's authority to adjudicate under 21 U.S.C. 823(f). I
also reject the ALJ's finding that Respondent violated Federal law by
administering controlled substances at a non-registered location.
However, I agree with the ALJ that Respondent has failed to accept
responsibility with respect to his ingestion of cocaine in December
2007. Accordingly, I make the following findings.
Findings of Fact
Respondent is a doctor of medicine with training in physical
medicine and rehabilitation who currently practices geriatric medicine
in Dallas, Texas. Tr. 261 & 265; GX 3, at 1. Respondent has been
licensed by the Texas Medical Board since May 10, 1997. GX 3, at 1.
Respondent previously held DEA Certificate of Registration,
BB5278141, which authorized him to dispense controlled substances as a
practitioner. GX 11, at 5. However, as discussed more fully below, on
November 7, 2003, the Texas Medical Board suspended Respondent's
medical license for a period of six months, GX 4, at 3-4; and on
January 15, 2004, Respondent surrendered this registration. GX 11, at
2.
On October 28, 2004, after the State restored Respondent's medical
license, Respondent obtained a new practitioner's registration,
BB8997857, for the location of 4300 MacArthur Ave., Suite 265, Dallas,
Texas. Id. at 2. On July 24, 2007, Respondent applied to both renew and
modify the registration by changing his registered location to 1901
Central Drive, Suite 805, Bedford, Texas. Id. While Respondent was
issued a new certificate for the Bedford address, the Agency did not
renew his registration. GX 1. On January 8, 2009, Respondent submitted
a new request to modify his registration by changing the address to
2735 Villa Creek Drive, Suite 110C, Dallas, Texas. GX 11, at 2.
The State Investigations
On April 16, 2002, Respondent was stopped by a police officer for
driving with a defective brake light. GX 2. During the stop, the
officer determined that Respondent's driver's license was suspended and
arrested him. Id. While being processed at the jail, Respondent was
found to have in his possession a small quantity of cocaine. GX 3, at
2. Respondent also ``admitted to a history of recreational cocaine
abuse.'' Id.
Respondent was subsequently indicted for the offense of possession
of a controlled substance, in the amount of less than one gram, a
felony under Texas law. Id. On November 27, 2002, the state court
placed Respondent on deferred adjudication. Id.
Thereafter, on August 15, 2003, Respondent entered into an Agreed
Order with the Texas Medical Board. Id. at 1. The order noted that on
October 8, 2002, Respondent met with the Physician's Health and
Rehabilitation Committee of Medical City Hospital, Dallas, and entered
into a recovery contract, the terms of which included ``an evaluation
by an addictionologist and treatment, if recommended[;] abstention from
drugs and alcohol; limitation of [his] prescribing authority; and
random urine testing through the Texas Medical Association.'' Id. at 2.
The Board imposed various terms and conditions for a period of five
years. As relevant here, the terms included that: (1) Respondent
abstain from consuming ``alcohol, dangerous drugs, or controlled
substances in any form unless prescribed by another physician to [him]
for a legitimate and documented therapeutic purpose''; (2) Respondent
submit to random testing for alcohol or drug use ``either through a
urine, blood, or hair specimen, at the request of'' the Board,
``without prior notice,'' and at his own expense; (3) either a positive
test result or his refusal to submit to a test would constitute a
violation of the order and subject his license to an immediate
suspension without a hearing; (4) Respondent submit to a psychiatric
evaluation, and if recommended, undergo psychiatric care and treatment;
(5) Respondent participate in either a program of Narcotics Anonymous
or a substantially similar program; and (6) Respondent ``participate in
the activities of a county or state medical society committee on
physician health and rehabilitation, including participation in weekly
meetings, if any''; and (7) Respondent pay an administrative penalty of
$5,000 within sixty days of the order. Id. at 4-8.
Pursuant to the Agreed Order, on October 14, 2003, Respondent
provided a specimen, which ``tested positive for cocaine.'' GX 4, at 2.
On November 7, 2003, the Board found that Respondent had ``failed to
abstain from the consumption of dangerous drugs or
[[Page 49982]]
controlled substances'' and had violated the Agreed Order. Id.
Moreover, during a show cause proceeding before the Texas Board,
Respondent admitted that he had not paid the administrative penalty.
Id.
During the state proceeding, Respondent asserted that his positive
test result was caused by his ex-girlfriend's having spiked a soft
drink without his knowledge. Id. In support of his claim, Respondent
submitted a ``hand-written statement,'' which he claimed was from his
ex-girlfriend.\2\ Id. The Board apparently did not buy his story as it
determined that he had violated the Agreed Order and suspended his
state license ``for a minimum period of six months'' while continuing
in effect the terms of the Agreed Order. Id. at 3. The suspension
remained in effect until October 8, 2004, when the Board terminated it
upon finding that Respondent was in compliance with the terms of the
Agreed Order. GX 5, at 2-3.
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\2\ At the instant hearing, Respondent admitted repeatedly that
he had lied to the Board about this incident. Tr. 311-12. Explaining
his conduct, Respondent testified that he was in denial, and that
when ``you're up against a wall * * * you're going to lie. You're
going to try to pull the wool over people's eyes.'' Id. at 312. He
insisted, however, that he is not on cocaine. Id. at 315.
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On August 3, 2005, the Board filed a Complaint against Respondent
based on violations of the Texas Medical Practice Act. GX 6, at 1.
Therein, the Board alleged that on February 8, 2005, Respondent
consumed alcohol and thereby violated the Agreed Order, and that he
also failed to report this incident as required by the Agreed Order.
Id. at 2. The Board further alleged that on March 2, 2005, Respondent
failed to call in to determine whether he was required to submit a
sample for drug testing, and that the next day, Respondent provided a
sample, which tested positive for EtG (Ethyl Glucoronide), a marker for
alcohol use. Id.
On February 3, 2006, the Board and Respondent entered into a
Mediated Agreed Order. GX 7, at 1. Therein, the Board found that
``Respondent did report an unintentional ingestion of alcohol,'' but
that ``the report was late.'' Id. at 2. The Board further found that
Respondent ``tested negative for alcohol.'' Id. While the Board also
found that ``Respondent was late for a call-in * * * he submitted a
sample two days later that was negative.'' Id. Finally, the Board found
that Respondent's ``compliance officer reports he is currently in
compliance with his Order.'' Id. The Board reprimanded Respondent and
imposed a $5,000 administrative penalty on him. Id. at 3.
On December 13, 2007, Respondent was subjected to a random urine
drug screen. The specimen, which was analyzed using an initial test and
confirmed through the Gas Chromatography and Mass Spectrometry methods,
was positive for cocaine metabolites at the level of 627 ng./ml., an
amount more than four times the 150 ng./ml. level which confirms a
positive test result. GX 8, at 2 & 4. The result was confirmed by a
retest of Respondent's specimen, which was conducted by a second
laboratory. Id. at 5.
On December 19, before the retest of his urine sample was
completed, Respondent submitted a hair specimen, which represented
three to four months of growth, for screening by another laboratory. RX
2, at 1. Respondent's specimen tested negative for prohibited
substances including cocaine and its metabolites. Id. On January 10,
2008, Respondent submitted an additional hair specimen for screening.
RX 3, at 1. This specimen also tested negative for cocaine and its
metabolites. Id.
To address these conflicting test results, the Government called
Dr. Angela Springfield as an expert witness. Tr. 22. Dr. Springfield
holds a PhD in Pharmacology and Toxicology, has served as Chief
Toxicologist for Tarrant County, Texas for more than twenty-five years,
and was an Assistant Professor at the University of North Texas Health
Science Center. GX 12. Dr. Springfield is a member of the Society of
Forensic Toxicology and of the American Academy of Forensic Sciences,
and holds a diploma from the latter organization. Id. at 2; Tr. 22. Dr.
Springfield was qualified as an expert in toxicology.
Dr. Springfield testified that urine drug screening uses an
``enzyme mechanism'' which looks for various ``classes of drugs'' such
as cocaine by causing a ``reaction above a given cut off point.'' Id.
at 24. The sample is then tested using the gas chromatography-mass
spectrometry method, ``which identifies the component in the urine, and
then quantitates the * * * amount of drug that may be present in the
sample.'' Id. Dr. Springfield further testified that urine drugs tests
are ``very reliable'' and will detect cocaine usage within 36 to 48
hours of ingestion. Id. at 25.
Dr. Springfield testified that hair testing uses a similar process
in which the specimen is ground up into a powder or other form and
subjected to a preliminary test and, if a positive result is returned,
is then tested using gas chromatography-mass spectrometry. Id. at 27-
29. Dr. Springfield stated that hair testing is also ``very reliable''
and that the drug binds itself to melanin in the hair and will stay
there until it has been cut. Id. at 28-29. However, because the drug
enters the hair in the bulb, it ``takes four or five days before the
hair'' containing the drug ``extrude[s] from the scalp.'' Id. at 30.
With respect to the first urine drug screen, Dr. Springfield
testified that the report indicated that a ``Quantitative Result'' of
Cocaine Metabolite in the amount of 627 ng./ml. When asked by the ALJ
if that was the result of the ``GC-mass spec test?,'' Dr. Springfield
answered: ``I'm assuming that is a mass spec test. They have GC here.''
Tr. 33. Apparently, this was a reference to a notation on the lab
report: ``Test confirmed by GC.'' GX 8, at 4. Dr. Springfield then
explained: ``A GC and a GC-mass spec are two different instruments. I
would have thought they would put GC-mass spec on there.'' Tr. 34. Dr.
Springfield testified that she assumed that the reference to GC on page
4 of the lab report was to ``GC-mass spec'' based on the first page of
the report which indicated Respondent's positive test result for
cocaine metabolites and that the quantitative levels for a positive
result under both the initial test (300 ng./ml.) and the GC/MS
Confirmation (150 ng./ml.). Id. at 35. Dr. Springfield testified,
however, that based on this report, this particular [urine] sample
contained the presence of benzoylecgonine and by inference, cocaine.
Id. at 38.
Dr. Springfield further testified that the second report confirmed
the findings of the first test. Id. at 40. While there is no indication
on the report form as to what procedures were followed in conducting
the test, GX 8, at 5; and no evidence was adduced showing what
procedure the lab follows for a retest, Respondent did not challenge
the adequacy of the procedures used in conducting the retest.
In any event, Dr. Springfield testified that there was no way to
tell whether the cocaine was ingested by snorting it or drinking it.
Id. at 41. She further testified that if a person ``took small doses,
[he] might not be aware if [he was] in a party situation. If [he] were
having a good time, [he] might not notice whether [he is] ingesting
that or not.'' Id. at 42.
Dr. Springfield then testified that the negative hair test results
could support either of two conclusions. Id. First, that Respondent did
not use drugs. Id. at 44. Second, that the drug used was ``outside of
the limitations of the hair.'' Id. at 45. With respect to the first
sample, Dr.
[[Page 49983]]
Springfield explained that ``there's a possibility that hair had not
been extruded'' from Respondent's scalp between the time of ingestion
and the taking of the sample. Id. at 46.
As for the second sample, Dr. Springfield testified that the other
possibility is that ``the amount of the drug that was used was small
enough to not be detected'' by the testing process. Id. at 45. Dr.
Springfield further testified that while the 600 nanograms of
metabolite which were detected in the urine screen were above the cut-
off, this number does not indicate ``that somebody is a binge user.''
Id. Continuing, Dr. Springfield added that ``it may well be that the
dose was not high enough to sequester in sufficient amount to be
detected in this second process.'' Id.
However, Dr. Springfield acknowledged ``that sufficient time had
elapsed'' for ingested drug to be present in the hair which was tested
in the second sample and that she ``would have expected to have seen
benzoylecgonine [cocaine metabolite] in that sample.'' Id. at 46. Dr.
Springfield explained that there might well have been drug present but
that the drug was below the cutoff level and was not reported as a
positive test. Id. She thus concluded that Respondent's negative hair
tests neither confirmed nor refuted the urine test. Id. at 47.
On cross-examination, Dr. Springfield testified that she could not
say whether or not 627 nanograms per milliliter is a lot of cocaine
because it would depend on how soon the sample was taken after
ingestion. Id. at 53. However, she reiterated that this level could
``very well * * * be under the detection limits'' and that hair testing
is not ``sensitive enough to see low doses of cocaine'' and probably
would not pick up either ``[a] small one-time use or a two-time use of
a small amount.'' Id. at 61. Dr. Springfield also stated that this is
widely accepted in the scientific community. Id. at 53-54. Respondent
did not refute this testimony.
On cross-examination, Respondent questioned Dr. Springfield about
research she had performed which involved hair testing on Peruvian
mummies to determine the presence of cocaine. Id. at 72. In her
testimony, Dr. Springfield explained that the testing had found the
presence of cocaine metabolites in the mummies after many years. More
specifically, Dr. Springfield stated that while the Peruvians ``were
chronic users [of] cocaine,'' the ``levels were low'' and were ``not in
the 600 nanogram range.'' Id. at 72-74.
In his Exceptions, Respondent contends that Dr. Springfield's
testimony regarding the level of cocaine metabolites found in the
mummies contradicted her earlier testimony that the level of 600
nanograms in urine would be under the detection limits of the hair
test. Exceptions at 2-3. Respondent, however, produced no evidence that
the ingestion of an amount of cocaine would result in the presence of
cocaine metabolites in hair at similar levels as would be found in
urine. Notably, hair testing results are typically expressed in
picograms per milligram, a unit which is one one-thousandth of a
nanogram. As Respondent's hair test results indicate, a positive test
for benzoylecgonine would be triggered by a level of 300 picograms per
milligram, a level which is one two-thousandth of 600 nanograms. See RX
2-3. This suggests that the absolute amounts of cocaine metabolites
that are found in hair are three orders of magnitude lower than the
amounts which are found in urine. It thus also suggests that there was
no inconsistency in Dr. Springfield's testimony.
I thus conclude that Respondent's hair test results do not refute
the results of the December 13, 2007 urine sample. I therefore find
that sometime shortly before December 13, Respondent ingested cocaine.
Following his positive test for cocaine, Respondent, who had
apparently been summoned to appear before the Texas Medical Board,
obtained three letters to support his continued licensure. The first of
these (dated February 1, 2008) was from J. Douglas Crowder, M.D., a
general and forensic psychiatrist who has treated him since July 22,
2005. RX 9. Therein, Dr. Crowder stated that he has treated Respondent
eleven times and had ``never noted any evidence of substances abuse,
intoxication or withdrawal on mental status examination.'' Id. Dr.
Crowder further noted that Respondent ``has always seem dedicated to
his recovery program and quite focused on setting his life aright again
after having used cocaine in the past.'' Id. While acknowledging that
he could not ``know whether [Respondent] has been honest with me or
returned to cocaine use,'' Dr. Crowder wrote that ``my clinical
impression is that he has been honest and straightforward with me,
having freely admitted his past problems.'' Id. Dr. Crowder admitted
that he was speaking from a ``limited perspective'' but then claimed
that ``all the data available to me indicate that [his] trace positive
result in December was a false positive result rather than due to
renewed cocaine use.'' Id. Dr. Crowder further stated that ``I would
consider him fully rehabilitated.'' Id. Of note, however, nowhere in
his letter did Dr. Crowder indicate that he had examined Respondent
following his positive test.
The second letter (dated February 11, 2008) which Respondent
produced was from Rahn K. Bailey, M.D., a board certified psychiatrist,
and was addressed to the Texas Board of Medical Examiners. RX 10.
Therein, Dr. Bailey stated that he had been seeing Respondent since
February 7, 2007, and had done a psychiatric evaluation of him on
February 11, 2008. Id. According to Dr. Bailey, Respondent's ``mental
status is within normal limits,'' ``there is no current impairment,''
and his ``[c]ocaine dependence [is] in remission.'' Id. Dr. Bailey
further stated that he planned to release Respondent from his care. Id.
However, Dr. Bailey's letter contains no indication that he was aware
that Respondent had failed a drug test just two months earlier. See id.
Finally, Respondent produced a letter from Vella V. Chancellor,
M.D., the Chair of the Physician's Recovery Committee of the Dallas
County Medical Society. RX 11. Dr. Chancellor wrote that Respondent
``has been actively seeing our committee since April 2005'' and that
``[s]ince that time he has complied with every aspect of our
committee's goals.'' Id. Dr. Chancellor also stated that in the
committee's opinion, Respondent ``takes his recovery very seriously and
he remains committed to maintaining both his recovery and a healthy
medical practice for his patients.'' Id.
On August 15, 2008, the conditions imposed by the August 15, 2003
Agreed Order expired. RX 4. By letter dated August 18, 2008, the Texas
Medical Board notified Respondent that ``all restrictions and
conditions imposed by the Agreed Orders are removed by the expiration
of the terms of the Order'' and that Respondent's license status was
changed to ``CL--Board Order Cleared.'' Id.
In his testimony, Respondent testified that when he was notified by
the Board of his positive test result, his ``jaw dropped to the
floor.'' Tr. 282. Recognizing that the test result ``was a death
sentence'' professionally, Respondent underwent both the hair tests and
a polygraph (the latter is not, however, in evidence). Id. at 282-83,
313. He further testified that he had ``taken almost 400 urine tests''
during the period in which he was subject to the Agreed Order and had
gone to hundreds of meetings and the Twelve Step Program. Id. at 281.
He also testified that at the time of the positive test, he was ``only
eight months away'' from completing the Agreed Order, and it would not
``make sense for somebody to
[[Page 49984]]
relapse'' at that point. Id. at 283. He then maintained that just as
there is ``no such thing as one potato chip * * * [t]here's no such
thing as one beer, one line,'' the latter presumably being a reference
to cocaine. Id.
Later, in response to the ALJ's question as to why his testimony
should be believed when he had previously lied to the State Board and
submitted a false letter, Respondent acknowledged that he had lied to
the Board. Id. at 314. Continuing his testimony, he stated:
Today, I mean, we're talking about not a letter from my ex-
girlfriend. We're talking about a letter from specialists that work
with the Medical Board, two of them, and a whole panel of
physicians.
Are you telling me that I pulled the wool over their eyes and
faked them out? Are you telling me that I somehow faked out two hair
tests and passed a polygraph test? I must be damned good. I'm that
good? And, no. I'm not that good. I'm just being honest. * * * I
know what I did, and I'll admit to it. I know what I didn't do, and
I'm going to fight for my right.
Id. at 314-15.
The Federal Investigation
Allegations Pertaining to HGH
In June 2006, a U.S. Postal Inspector intercepted a package
containing human growth hormone (HGH) which was addressed to R.G., a
resident of Fort Worth, Texas, and which had been mailed from an
address in Vancouver, Canada. GX 10; Tr. 137. The Postal Inspector
contacted R.G., who stated that Respondent was his doctor and that he
had obtained a prescription for HGH from him. Id. at 137-38.
At the hearing, R.G. testified that sometime in either later 2003
or early 2004, he had heard Respondent discuss testosterone treatment
on a radio program. Id. at 103-04. Because of his age (45) and the fact
that his workouts were not ``going well,'' R.G. thought that he
possibly had a low testosterone count and went to see Respondent. Id.
at 104-05. At R.G.'s first visit, he completed a questionnaire and
Respondent performed a physical exam on him and ordered a blood test.
Id. at 105-06; 125. According to R.G., the blood test showed that he
``did have low testosterone.'' Id. at 106. Respondent reviewed the
physical exam findings and various treatment options with R.G. Id.
After obtaining the blood test results, Respondent put R.G. on
testosterone and HGH. Id. at 107-08. According to R.G.'s memory,
Respondent recommended HGH basically as an ``anti-aging'' treatment.
Id. at 108. The record established that Respondent issued R.G. three
prescriptions for HGH (on April 23, August 30 and October 7, 2005), the
latter one being for Jintropin,\3\ and one prescription for
testosterone cypionate (on May 10, 2005). See GX 9. R.G. also testified
as to obtaining additional prescriptions. Tr. 127. However, R.G.
testified that Respondent performed blood tests ``every six months,''
and that each time the tests were done, he had a testosterone
deficiency. Id.
---------------------------------------------------------------------------
\3\ The parties stipulated that Jintropin is a form of HGH,
which has not been approved by the FDA for use in the United States.
ALJ Ex. 8, at 2. According to an FDA Special Agent, Jintropin is
manufactured in China. Tr. 90. According to the DI, during an
interview Respondent stated that he had prescribed Jintropin because
``it was cheaper.'' Id. at 153. The DI further testified that
Respondent ``was unaware'' that Jintropin ``was not DEA approved.''
Id. DEA does not, however, approve drug products. The DI also
testified that she did not know whether Respondent knew that
Jintropin was made in China. Id.
In his testimony, Respondent stated that he did not know that
Jintropin was not FDA approved and ``apologized for that.'' Id. at
316. Respondent explained that it was his understanding that
``Jintropin was a generic type of HGH.'' Id. Respondent then
testified: ``I understand ignorance is not an excuse, but that's the
truth.'' Id. He maintained, however, that ``[t]he only reason I
prescribed the Jintropin in a few circumstances * * * was because it
was less expensive.'' Id. at 317. Respondent then stated that he was
no longer practicing anti-aging medicine, and had stopped doing so
in ``early 2007.'' Id. at 319 & 326-27.
---------------------------------------------------------------------------
On some date which is not clearly established in the record, R.G.
expressed his concern about the cost of the HGH and Respondent provided
him with the name of a Web site which could fill his prescriptions and
which was located in Vancouver, Canada. GX 9, at 5; Tr. 116-17. R.G.
acknowledged that he had ordered HGH from the Web site including the
package which was intercepted by the Postal Inspector. Id. at 119, 121.
R.G. also testified that he had to take the testosterone to Respondent,
who was then practicing at the Spa 02, to have it administered. Id. at
114. This happened either once a month or every two weeks at most. Id.
However, as noted above, the record contains but a single testosterone
prescription. Nor did the Government introduce R.G.'s patient file to
show the duration of Respondent's administration of testosterone to
him.
According to an FDA Special Agent, human growth hormone is approved
for ``short stature for children, AIDS-wasting patients, short bowel
syndrome in adults, and there's several other that are pertaining to
children's growth.'' Id. at 89-90. More precisely, Genotropin has been
approved for: (1) ``[l]ong-term treatment of pediatric patients who
have growth failure due to an inadequate secretion of endogenous growth
hormone''; (2) ``[l]ong-term treatment of pediatric patients who have
growth failure due to Prader-Willi syndrome''; (3) ``[l]ong-term
treatment of growth failure in children born small for gestational age
* * * who fail to manifest catch-up growth by age 2''; and (4)
``[l]ong-term replacement therapy in adults with growth hormone
deficiency * * * of either childhood--or adult onset etiology.''
Physicians' Desk Reference 2738-39 (59th ed. 2005). See also United
States ex rel. Rost v. Pfizer, Inc., 507 F.3d 720, 723 (1st Cir. 2007).
As noted above, the Government did not introduce into evidence
R.G.'s patient file. Nor did it call any expert witness to testify as
to whether Respondent had a legitimate medical purpose and acted within
the usual course of professional practice in prescribing testosterone
to R.G.
As for his prescribing of human growth hormone, Respondent
maintained that, while the drug is not approved for anti-aging, it ``is
approved for adult growth hormone deficiency syndrome,'' and that his
diagnoses of this condition in his patients were ``based on a
combination of factors'' including ``clinical symptoms and examination
and blood work.'' Tr. 332. He also testified that R.G.'s blood work and
clinical manifestations supported a diagnosis of ``somatopause, which
is adult growth hormone deficiency syndrome.'' Id. at 337. Here again,
to the extent Respondent's prescribing of human growth hormone is even
within the authority of this Agency to adjudicate, the Government did
not call a medical expert to refute his testimony.
The Government also introduced a document showing additional
prescriptions written by Respondent for Genotropin and testosterone
cypionate for several other patients and which were dispensed by a Las
Vegas, Nevada pharmacy. See GX 16. According to a Diversion
Investigator, she contacted the five patients whose names were not
redacted in the exhibit and ``some of them'' said that they had
received HGH for anti-aging purposes, but she could not recall which
ones. Tr. 201-02. Moreover, the Government did not produce any evidence
that the prescriptions for testosterone were unlawful. Finally, when
asked with respect to these five patients, whether there is anything
``illegal * * * about these drugs,'' the DI testified that ``there
[was] nothing illegal about'' Respondent's prescribing them ``[i]f he
has a doctor-patient relationship with these patients'' and that she
had verified that he did. Id. at 245. See also id. at 164 (testimony of
another DI that she could not testify as to the legality of
Respondent's prescribing of Somatropin, another HGH product).
[[Page 49985]]
On some date not established by the record, the Texas Medical Board
(``Board'') also commenced an investigation into Respondent's
prescribing of Jintropin. See RX 7. On February 9, 2009, Respondent
entered into an Agreed Order with the Board. See RX 12, at 9. Therein,
the Board found that ``respondent prescribed Jinotropin, a non-FDA-
approved human growth hormone * * * to a single patient without
verifying the substance was FDA approved.'' Id. at 2. The Board did
not, however, find that Respondent's prescribing of HGH for anti-aging
purposes was a violation of the Texas Medical Practice Act and the
Board's rules. See id. at 1-3.
The Board ordered that Respondent ``take and pass'' the ``Medical
Jurisprudence Examination'' which is administered by the Board, and
that his failure to do so within one year of the order would subject
his state license to an immediate suspension without a hearing. Id. at
3. The Board also ordered that Respondent ``successfully complete 10
hours of Continuing Medical Education * * * in the area of ethics,''
and that his practice be monitored by a physician approved by the
Board's Compliance Division, who is to review selected medical and
billing records. Id. at 4. The Board further ordered that Respondent
``pay an administrative penalty in the amount of $4000.'' Id. at 5.
Allegations Pertaining to Respondent's Controlled Substance Prescribing
and Failure To Update His Registered Location
The Government also alleged that Respondent dispensed narcotics for
narcotic treatment purposes without holding the authorization required
by 21 U.S.C. 823(g) and 21 CFR 1301.13. In support of the allegation,
the Government introduced into evidence several prescriptions which
Respondent issued to D.M. for methadone (10 mg.), a schedule II control
substance. See GX 11, at Tab E; see also 21 CFR 1308.12(c). According
to a DEA Diversion Investigator, D.M. told her that before Respondent
agreed to treat him, he had gone to several other doctors who wrote him
prescriptions for OxyContin in ``enormous amounts,'' and that
Respondent agreed to prescribe methadone and ``told him that eventually
he would be able to lower his doses, because he was so addicted to the
OxyContin.'' Tr. 188-89. However, D.M. told the DI that he had
previously injured his back and suffered back pain. Id. at 188 & 232.
According to the DI, upon being questioned about his treatment of
D.M., Respondent ``told us that he weaned patients'' off of narcotics.
Id. at 251. She further testified that she understood this statement to
mean that Respondent was treating drug addicts. Id. at 252. Respondent
does not hold a registration to conduct a narcotic treatment program,
and is not authorized to treat and detoxify patients with Suboxone. Id.
at 190-91.
On cross-examination, the DI testified that when she interviewed
D.M., she could not determine that he was addicted and that he had told
her that Respondent was prescribing methadone to him for pain and that
D.M. ``felt like he was functioning.'' Id. at 232-33. The DI also
testified that she subpoenaed D.M.'s records, and that she believed
D.M.'s statement that the methadone was being prescribed for legitimate
pain management. Id. at 233. The DI then admitted that she does not
``have the expertise to determine'' whether D.M. was a legitimate
chronic pain patient. Id. at 254-55.
D.M. testified as a witness for Respondent. D.M. stated that he had
undergone three back surgeries and that another physician had been
prescribing methadone to him for pain management for several years when
he met Respondent.\4\ Id. at 490-91. While D.M. testified that
Respondent did not ask him to provide his medical records, he further
stated that Respondent performed a physical examination on him which
included checking his blood pressure and lungs, having him touch his
toes, and feeling the area where either a TENS unit or a stimulator had
been placed in his back. Id. at 504, 506, 508. D.M. also stated that
Respondent had successfully tapered his methadone dosage from 160 mg.
to 60 mg. and that he was now ``able to do a lot of things'' that he
could not do previously. Id. at 492-93.
---------------------------------------------------------------------------
\4\ D.M. worked at a halfway house for probationers where
Respondent had performed community service and then volunteered.
---------------------------------------------------------------------------
Respondent likewise testified that D.M. was being treated with
methadone ``for chronic pain'' and ``not for heroin addiction.'' Id. at
343. While he acknowledged having used ``the word `wean' '' in
discussing his treatment of D.M., he maintained that he was not
``running a methadone clinic,'' id., that D.M. was already on methadone
(160 mg.) when he first saw him, and that he had tried to find the
right balance between controlling D.M.'s pain and maximizing his
ability to function. Id. at 341.
The Government did not introduce into evidence D.M.'s medical
records. Nor did it elicit any expert testimony probative of whether
Respondent's prescribing to D.M. was lawful under Federal law. Based on
the record as a whole, I find that Respondent issued the methadone
prescriptions to treat D.M.'s chronic pain and not to provide either
maintenance or detoxification treatment for him.
The Government also elicited testimony regarding Respondent's
prescribing of hydrocodone, a schedule III controlled substance, to
D.C., and clonazepam, a schedule IV controlled substance, to R.S. Id.
at 194-96; see also GX 18. A DI asserted that both of these individuals
were residents of Seidler House, a halfway house which forbids its
residents from being prescribed controlled substances. Tr. 196.
While J.S., the assistant director of Seidler House, testified that
it does not accept persons who are ``not clean and sober,'' id. at 516,
he further stated that Respondent had ``never'' prescribed a controlled
substance to a resident. Id. at 524-25. J.S. also testified that D.C.,
who had received a single hydrocodone prescription from Respondent,
``was a full-time staff member,'' and that he believed that the script
was to treat pain caused by a staph infection which D.C. developed and
for which he was hospitalized for thirty days.\5\ Id. at 525. J.S.
testified that R.S. had become an employee a month or so before he saw
Respondent, and that in any event, it was standard procedure that ``a
staff member could not get anything from [Respondent] without the
director knowing and having it locked'' up and monitored to ``make sure
it was dispensed according to the prescription.'' Id. at 530. J.S.
reiterated that to his knowledge, Respondent never violated the halfway
house's policy by prescribing controlled substance to a resident. Id.
at 530-31. According to Respondent, he prescribed the clonazepam to
R.S. for anxiety, the prescription was documented in a medical record,
and the drug was ``put in a lock box'' at Seidler House. Id. at 349.
---------------------------------------------------------------------------
\5\ Respondent had earlier testified that he had prescribed
fifteen tablets of hydrocodone to D.C. for acute back pain caused by
a disk problem, which was kept in a lock box at Seidler House. Tr.
347. Respondent's testimony regarding the size of the prescription
is corroborated by the actual prescription. GX 18. Respondent also
stated that he had prescribed antibiotics to D.C. Tr. 347. He also
testified that he discussed any controlled substance prescriptions
with the owner of Seidler House. Id. at 348.
---------------------------------------------------------------------------
Here again, there is no evidence that Respondent's controlled
substance prescriptions to either D.C. or R.S. were unlawful. Finally,
J.S. testified that Respondent was awarded several plaques for his
service to Seidler House.
[[Page 49986]]
The Government also alleged that Respondent failed to keep his
registered address current. ALJ Ex. 1, at 1. As found above, Respondent
was registered at 4300 MacArthur Ave, Suite 265, Dallas, Texas from
October 28, 2004, through July 24, 2007, when his registered location
was changed to 1901 Central Drive, Suite 805, Bedford, Texas. GX 11, at
5. There is evidence that Respondent wrote controlled substance
prescriptions while he was practicing at other addresses. See id. at
Tab B (prescriptions using address of 1032 West Pioneer Parkway,
Arlington, Texas); id. at Tab D (prescriptions using address 1701
Legacy Drive, Suite 100, Frisco, Texas)\6\; id. at Tab E (prescriptions
using address of 2735 Villa Creek, Suite 110 C, Dallas, Texas). There
was also testimony that Respondent administered testosterone to R.G. at
the Spa O2 clinic because R.G. had difficulty injecting himself. Tr.
114. However, the evidence shows that R.G. obtained the testosterone
through a prescription, which suggests that he brought it with him to
the clinic, and in any event, there is no evidence that Respondent
ordered controlled substances which were delivered to, and stored at,
the clinic.
---------------------------------------------------------------------------
\6\ This was the address of the Spa O2 clinic. Tr. 145.
---------------------------------------------------------------------------
The evidence also established that Respondent did not own the Spa
O2 clinic, but was merely associated with it. Id. at 94. There is,
however, no evidence establishing who owned this clinic and whether the
clinic was owned by a registered practitioner.
During an interview with a DI, Respondent admitted to practicing at
these locations. Id. at 153-55. While he had no explanation for why he
had not kept his practice locations current, he ``apologized for not
having done so.'' Id. at 155. Moreover, at the hearing, Respondent
testified that while he mainly practiced at the MacArthur address,
having previously lost his medical license, he was ``in the process of
rebuilding'' his practice and ``moonlighted'' at ``multiple places.''
Id. at 270. He further testified that he had notified the Texas
authorities whenever he changed his practice location, and had ``simply
overlooked'' the DEA registration. Id. at 271. Respondent then
testified: ``I apologize for it, and it will never happen again.'' Id.
Discussion
Section 304(a) of the Controlled Substances Act (CSA) provides that
a registration to ``dispense a controlled substance * * * may be
suspended or revoked by the Attorney General upon a finding that the
registrant * * * has committed such acts as would render his
registration under section 823 of this title inconsistent with the
public interest as determined under such section.'' 21 U.S.C.
824(a)(4). Moreover, ``the Attorney General may deny an application for
[a practitioner's] registration if he determines that the issuance of
such registration would be inconsistent with the public interest.'' Id.
Sec. 823(f). With respect to a practitioner, the Act requires the
consideration of the following factors in making the public interest
determination:
(1) The recommendation of the appropriate State licensing board
or professional disciplinary authority.
(2) The applicant's experience in dispensing * * * 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.
Id. Sec. 823(f).
``These factors are considered in the disjunctive.'' Robert A.
Leslie, M.D., 68 FR 15227, 15230 (2003). I ``may rely on any one or a
combination of factors, and may give each factor the weight [I] deem [
] appropriate in determining whether a registration should be
revoked.'' Id. Moreover, I am ``not required to make findings as to all
of the factors.'' Hoxie v. DEA, 419 F.3d 477, 482 (6th Cir. 2005); see
also Morall v. DEA, 412 F.3d 165, 173-74 (DC Cir. 2005).
As explained below, having considered all of the factors, I adopt
the ALJ's ultimate conclusion that Respondent's continued registration
is inconsistent with the public interest and that his registration
should be revoked. However, the only misconduct proved on this record
involves Respondent's self-abuse of a controlled substance.
Accordingly, while I conclude that the revocation of Respondent's
registration is necessary to protect the public interest, I further
order that in the event Respondent undergoes and successfully completes
in-patient treatment as well as additional random drug testing, which
shall be at his own expense, the Agency shall give favorable
consideration to a new application after a period of one year from the
effective date of this Order.\7\
---------------------------------------------------------------------------
\7\ In his Exceptions, Respondent argues that the ALJ erred in
finding that an Agency DI was not biased against him. Exceptions at
3. He also maintains that the DI violated his rights to procedural
due process because she told his counsel that he ``could not
prescribe controlled substances until further notice from the''
Agency. Id.
In light of my rejection of all the allegations with the
exception of those pertaining to Respondent's failed drug test,
there is no need to address the contention that the DI was biased
against him. As for the second contention, the DI's advice was not a
formal order of the Agency and does not rise to the level of a
constitutionally significant deprivation of a property interest.
---------------------------------------------------------------------------
Factor One--The Recommendation of the State Licensing Board
At the outset, it should be noted that the Texas Medical Board has
not made a formal recommendation as to what action this Agency should
take in this matter. However, DEA precedents have typically taken a
broader view as to the scope of this factor. See Edmund Chein, 72 FR
6580, 6590 (2007).
As the record demonstrates, Respondent is no stranger to the
disciplinary proceedings conducted by the Texas Medical Board. As found
above, Respondent and the Board have entered into several agreed orders
which have imposed extensive conditions on him. The Board, however, has
allowed the 2003 Agreed Order to expire notwithstanding Respondent's
failed drug test and Respondent is currently authorized to practice
medicine in Texas and presumably is authorized to handle controlled
substances.\8\
---------------------------------------------------------------------------
\8\ Texas requires that a practitioner obtain a state-issued
controlled substances registration. There is no evidence in the
record as to the status of Respondent's registration.
---------------------------------------------------------------------------
Although Respondent's licensure status satisfies an essential
requirement for holding a registration under CSA, this Agency has
repeatedly held that possessing a valid state license is not
dispositive of the public interest inquiry. See Patrick W. Stodola, 74
FR 20727, 20730 (2009); Robert A. Leslie, 68 FR 15227, 15230 (2003).
While the Board has allowed the 2003 Agreed Order to expire, as
explained more fully below, the evidence presented in this case shows
that Respondent still has a cocaine problem. Accordingly, I decline to
treat the Board's action as a recommendation to continue Respondent's
registration. I therefore adopt the ALJ's conclusion that this factor
neither ``weigh[s] for or against [the] determination'' that
Respondent's continued registration is consistent with the public
interest. ALJ at 24.
[[Page 49987]]
Factors Two, Four, and Five--Respondent's Experience in Dispensing
Controlled Substances, Record of Compliance With Laws Relating to
Controlled Substances and Such Other Conduct Which May Threaten Public
Health and Safety
Reasoning that ``[m]any of the Respondent's controlled substance
prescribing practices impact not only Factor 2 * * *, but also Factors
4 * * * and 5[,] '' the ALJ combined these three factors in his
analysis of the Government's case. ALJ at 28. While the ALJ correctly
rejected the Government's allegation pertaining to Respondent's
prescribing of methadone, he erroneously concluded that Respondent's
prescribing of human growth hormone violated the CSA's prescription
requirement. See ALJ at 30. His further conclusion that Respondent's
prescribing of human growth hormone could be considered under factor
five is not supported by Agency precedent, has been previously
rejected--at least implicitly--by the Agency, and would require this
Agency to exercise authority which the Supreme Court has made clear it
does not possess.
The ALJ did, however, correctly conclude that Respondent's history
of cocaine abuse should be considered under factor five. Moreover, I
also concur with the ALJ's conclusion that Respondent still does not
accept responsibility for his cocaine addiction.
Respondent's Prescribing Practices
As noted above, at the hearing, the Government put on evidence
regarding three different aspects of Respondent's prescribing
practices: (1) His prescribing of controlled substances to two persons
who allegedly were residents of Seidler house; (2) his prescribing of
methadone to D.M., which it alleges constituted ``dispensing narcotic
drugs for narcotic treatment without the'' authorization required by 21
U.S.C. 823(g) and 21 CFR 1301.13; and (3) his prescribing of human
growth hormone for anti-aging purposes.
Under a longstanding DEA regulation, a prescription for a
controlled substance is not ``effective'' unless it is ``issued for a
legitimate medical purpose by an individual practitioner acting in the
usual course of his professional practice.'' 21 CFR 1306.04(a). This
regulation further provides that ``an order purporting to be a
prescription issued not in the usual course of professional treatment *
* * is not a prescription within the meaning and intent of [21 U.S.C.
829] and * * * the person issuing it, shall be subject to the penalties
provided for violations of the provisions of law related to controlled
substances.'' Id. See also 21 U.S.C. 802(10) (defining the term
``dispense'' as meaning ``to deliver a controlled substance to an
ultimate user by, or pursuant to the lawful order of, a practitioner,
including the prescribing and administering of a controlled
substance'') (emphasis added).
As the Supreme Court recently explained, ``the prescription
requirement * * * ensures patients use controlled substances under the
supervision of a doctor so as to prevent addiction and recreational
abuse. As a corollary, [it] also bars doctors from peddling to patients
who crave the drugs for those prohibited uses.'' Gonzales v. Oregon,
546 U.S. 243, 274 (2006) (citing United States v. Moore, 423 U.S. 122,
135, 143 (1975)). Under the CSA, it is fundamental that a practitioner
must establish and maintain a bonafide doctor-patient relationship in
order to act ``in the usual course of * * * professional practice'' and
to issue a prescription for a ``legitimate medical purpose.'' Laurence
T. McKinney, 73 FR 43260, 43265 n.22 (2008); see also Moore, 423 U.S.
at 142-43 (noting that evidence established that physician ``exceeded
the bounds of `professional practice,''' when ``he gave inadequate
physical examinations or none at all,'' ``ignored the results of the
tests he did make,'' and ``took no precautions against * * * misuse and
diversion''). The CSA, however, generally looks to state law to
determine whether a doctor and patient have established a bonafide
doctor-patient relationship. See Kamir Garces-Mejias, 72 FR 54931,
54935 (2007); United Prescription Services, Inc., 72 FR 50397, 50407
(2007).
The Government put on evidence (which included both testimony and
documentary evidence) establishing that Respondent prescribed
hydrocodone (totaling 15 tablets) to D.C., and clonazepam to R.S., both
of whom it alleged were residents of Seidler House. Apparently, the
Government found this inappropriate because Seidler House has a policy
which forbids its residents from being prescribed controlled
substances. Yet the Government produced no evidence that either
prescription lacked a legitimate medical purpose or that Respondent
acted outside of the usual course of professional practice in
prescribing to these individuals. 21 CFR 1306.04(a). Thus, the
Government has failed to show that Respondent violated Federal law in
issuing the prescriptions.\9\
---------------------------------------------------------------------------
\9\ It is noted that this conduct was not alleged in the Show
Cause Order and that the Government did not disclose that it
intended to pursue these allegations in either of its pre-hearing
statements. See CBS Wholesale Distributors, 74 FR 36746, 36750
(2009). Respondent did not, however, object to this line of inquiry.
---------------------------------------------------------------------------
Having failed to put on any evidence relevant to whether these
prescriptions violated Federal law, perhaps the Government's theory was
(as notwithstanding the evidence it introduced on the issue, its brief
sets forth no legal theory) that Respondent's prescribing to these
persons is actionable as ``other conduct which may threaten public
health and safety'' because Seidler House's policy forbade its
residents from being prescribed controlled substances. 21 U.S.C.
823(f)(5). However, even assuming that this conduct is properly
considered under this factor, I would still reject the contention
because the Government failed to show that either person was a resident
of Seidler House at the time Respondent prescribed to them.
The Government also put on evidence regarding Respondent's
methadone prescriptions to D.M. Apparently, this evidence was the basis
of the Show Cause Order's allegation that Respondent was engaging in
narcotic treatment without the authorization required under 21 U.S.C.
823(g) and 21 CFR 1301.13. ALJ Ex. 1, at 2. As noted above, the ALJ
properly rejected this allegation as unsupported by substantial
evidence.
Under Federal law, ``practitioners who dispense narcotic drugs [in
schedule II] to individuals for maintenance treatment or detoxification
treatment shall obtain annually a separate registration for that
purpose.'' 21 U.S.C. 823(g)(1)(A) (emphasis added).\10\ While this
provision requires a separate registration when a practitioner seeks to
dispense methadone for the purpose of providing maintenance or
detoxification treatment for a patient, a practitioner may nonetheless
lawfully prescribe
[[Page 49988]]
methadone to a patient for pain management purposes under his
practitioner's registration. Id. Sec. 823(f).
---------------------------------------------------------------------------
\10\ To obtain this registration, a practitioner must meet three
main requirements. First, the Secretary of the Department of Health
and Human Services must determine that he is ``qualified (under
standards established by the Secretary) to engage in'' either
maintenance or detoxification treatment. 21 U.S.C. 823(g)(1)(A).
Second, the Attorney General must determine that he ``will comply
with standards established by the Attorney General respecting (i)
security of stocks of narcotic drugs for such treatment, and (ii)
the maintenance of records (in accordance with [21 U.S.C. 827]) on
such drugs.'' Id. Sec. 823(g)(1)(B). Third, the Secretary must
``determine[] that the applicant will comply with standards * * *
respecting the quantities of narcotic drugs which may be provided
for unsupervised use by individuals in such treatment.'' Id. Sec.
823(g)(1)(C).
---------------------------------------------------------------------------
Notwithstanding the DI's testimony that D.M. had told her that he
was addicted to OxyContin, there is no expert evidence establishing
that D.M. was a drug addict (as opposed to a patient who, over time,
developed opioid tolerance and required greater doses). Moreover,
notwithstanding that Respondent used the word ``wean'' to describe his
treatment of D.M., even the DI testified that she believed that D.M.,
who had undergone three back surgeries, was a legitimate chronic pain
patient.
While methadone is approved by the FDA, and has long been used, for
the treatment of opioid addiction, see 42 CFR 8.12(h)(2), the drug is
also approved for the treatment of pain. See FDA, Information for
Healthcare Professionals Methadone Hydrochloride (FDA Alert Nov. 2006).
Moreover, the record contains no expert evidence showing that
Respondent's prescribing of methadone was inconsistent with accepted
medical practice for prescribing the drug for pain management. Indeed,
it would seem that reducing the daily total dosage of a narcotic which
a patient needs to take to achieve adequate pain control while allowing
him to function is fully consistent with accepted medical practice. The
allegation is therefore not proved.
Finally, the Government put on extensive evidence regarding
Respondent's prescribing of human growth hormone. Moreover, in its
closing argument, the Government argued that the evidence showed that
Respondent had prescribed to five patients ``human growth hormone for
its anti-aging effects, and of course, that is an illegal, nonapproved
use.'' Tr. 576.
In his decision, the ALJ explained that ``human growth hormone is
not a controlled substance within the meaning of the CSA and is
controlled by the'' Anabolic Steroids Control Act. ALJ at 30. He
further observed that ``Respondent's issuance of a prescription for the
substance for purposes other than FDA-approved uses does not fall
squarely within the purview of the criminal statute.''\11\ Id. Citing
the CSA's prescription requirement (21 CFR 1306.04(a)), the ALJ then
explained: ``However, because he issued prescriptions for human growth
hormone for unauthorized uses and for Jintropin for any use, he
violated federal law by issuing prescriptions outside the usual course
of a professional practice.'' Id.
---------------------------------------------------------------------------
\11\ The ALJ did not clarify whether ``the criminal statute'' he
was referring to was the CSA or 21 U.S.C. 333(e), the provision of
the Food, Drug and Cosmetic Act, which criminalizes the ``knowing[]
distribut[ion] * * * [of] human growth hormone for any use in humans
other the treatment of a disease or other recognized medical
condition, where such used has been authorized by the Secretary of
Health and Human Service under [21 U.S.C. 355] and pursuant to the
order of a physician.''
---------------------------------------------------------------------------
The ALJ's reasoning is erroneous for two reasons: First, it fails
to recognize that the CSA's prescription requirement--in keeping with
the limited authority the CSA grants the Attorney General, see Gonzales
v. Oregon, 546 U.S. 243 (2006)--applies only to prescriptions for
controlled substances. Indeed, the text of the regulation could not
make this clearer. See 21 CFR 1306.04(a). As pertinent here, the
regulation states:
A prescription for a controlled substance to be effective must
be issued for a legitimate medical purpose by an individual
practitioner acting in the usual course of his professional
practice. The responsibility for the proper prescribing and
dispensing of controlled substances is upon the prescribing
practitioner, but a corresponding responsibility rests with the
pharmacist who fills the prescription.
21 CFR 1306.04(a) (emphasis added). See also 21 U.S.C. 802(6) (``The
term `controlled substance' means a drug or other substance or
immediate precursor, included in schedule I, II, III, IV, or V of part
B of this subchapter.'').
Second, while criminalizing conduct is a form of control, see
Merriam-Webster's Collegiate Dictionary 252 (10th ed. 1998), the ALJ
failed to recognize that, under the CSA, the term ``control'' is a term
of art which has been statutorily defined. See 21 U.S.C. 802(5)
(defining ``[t]he term `control' [to] mean[] to add a drug or other
substance, or immediate precursor, to a schedule under part B of this
subchapter, whether by transfer from another schedule or otherwise'').
Thus, while Congress criminalized certain conduct related to the
distribution of human growth hormone in the Anabolic Steroid Control
Act of 1990, most significantly, it did not include human growth
hormone when it amended the CSA to include anabolic steroids as
schedule III controlled substances. Anabolic Steroids Control Act of
1990, Public Law 101-647, 104 Stat. 4851-52 (1990) (codified at 21
U.S.C. 802(41)(A)). Indeed, the House Report, which accompanied the
legislation, specifically noted in several places that ``[h]uman growth
hormone * * * is often mistakenly considered an anabolic steroid.'' H.
Rep. No. 101-681(I), at 95 (1990), as reprinted in 1990 U.S.C.C.A.N.
6472, 6499. See also id. at 97, as reprinted in 1990 U.S.C.C.A.N. at
6501 (``Human growth hormone, often mistakenly considered an anabolic
steroid, is defined as `somatrem, somatropin or an analogue of either
of them.''').
Thus, contrary to the ALJ's understanding, human growth hormone was
not--unlike anabolic steroids-- ``controlled by the ASCA.'' Moreover,
the House Report makes clear that the ASCA's human growth hormone
provision ``amend[ed] * * * the Food, Drug and Cosmetic Act,'' and not
the CSA. Because it is not a controlled substance, Respondent's
prescribings of human growth hormone could not have violated the CSA's
prescription requirement. The conduct is therefore not relevant in
assessing either his experience in dispensing contorlled substances or
his record of compliance with laws related to controlled substances.
Factor five authorizes the Agency to consider ``such other conduct
which may threaten public health and safety.'' 21 U.S.C. 823(f)(5). The
ALJ correctly recognized that this factor authorizes the Agency to
consider ``a somewhat broader range of conduct reaching beyond those
activities typically'' associated with a registrant's practices in
dispensing controlled substances, ALJ at 31, and encompasses ``wrongful
acts relating to controlled substances committed by a registrant
outside of his professional practice but which relate to controlled
substances.'' David E. Trawick, 53 FR 5326, 5327 (1988). The Agency has
thus long held that ``all wrongful acts relating to controlled
substances committed by a registrant can be taken into consideration by
the Administrator when deciding whether to allow that registrant to
retain the privileges granted him by a DEA Certificate of
Registration.'' Id. However, our cases have established that for
conduct to be actionable under factor five, there must be a substantial
relationship between the conduct and the CSA's purposes of preventing
drug abuse and diversion, and that the conduct may constitute a threat
to public health and safety.\12\
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\12\ In his decision, the ALJ stated that ``an adverse finding
under this factor requires some showing that the relevant conduct
actually constituted a threat to public safety.'' ALJ at 31 (citing
Holloway Distributing, 72 FR 42118, 42126 (2007)). Holloway involved
a list I chemical distributor, and as such, a different standard
applied. See 21 U.S.C. 823(h)(5) (directing the consideration of
``such other factors as are relevant to and consistent with public
health and safety''). Moreover, no case of the Agency holds that the
conduct must constitute an ``actual threat,'' a reading which is at
odds with Congress' inclusion of the word ``may'' in the text of
factor five. See Merriam-Webster's Collegiate Dictionary at 719
(defining ``may'' to mean in part: ``used to indicate possibility or
probability'').
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[[Page 49989]]
Reasoning that ``[i]t would be difficult to conceive of a scenario
that hits closer to the mark of a dangerous prescribing practice than
the prescribing of substances for purpose that have not been approved
by the FDA and the prescribing of a substance not approved for any
purpose by the FDA,'' the ALJ concluded that Respondent's prescribing
of human growth hormone was ``relevant under factor five.'' ALJ at 31.
The ALJ's reasoning reflects a fundamental misunderstanding of
legitimate medical practice and would embark this Agency on a function
it has no authority to engage in.
Most significantly, even assuming that prescribing human growth
hormone for anti-aging purposes threatens public health and safety and
that prescribing it for this off-label use violates Federal law, the
ALJ erred in considering this conduct because he failed to identify how
Respondent's prescribing of human growth hormone is related to
controlled substances. While the record establishes that Respondent
also prescribed testosterone to various patients who were receiving
HGH, there is no evidence that Respondent lacked a legitimate medical
purpose and acted outside of the usual course of professional practice
in issuing the testosterone prescriptions. Moreover, that Respondent
may have issued the HGH prescriptions concurrent with his issuance of
testosterone prescriptions does not establish a substantial
relationship to controlled substances.\13\
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\13\ Nor is there any expert testimony establishing what a
physician must do to diagnose whether an adult patient has a human
growth hormone deficiency.
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To be sure, Agency decisions have at times discussed a
practitioner's prescribing of non-controlled drugs to provide factual
context. See, e.g., Paul H. Volkman, 73 FR 30630, 30633-34, 30636-37
(2008) (discussing physician's prescriptions for drug cocktails which
included opioids and benzodiazepines (both of which are controlled) and
carisoprodol (which is not controlled)); Edmund Chein, 72 FR 6580, 6582
(2007) (discussing physician's distribution of HGH to undercover
operatives). Yet in neither of these decisions did the Agency hold that
it has authority to adjudicate the medical propriety of a physician's
act in prescribing a non-controlled drug.
In Chein, my discussion of Respondent's dispensing violations
focused entirely on the physician's prescribing of controlled
substances and did so notwithstanding that the evidence showed that the
physician had distributed HGH to an undercover operative who sought the
substance for athletic enhancement. Compare 72 FR at 6582, with id., at
6590. To similar effect, in Volkman, notwithstanding the evidence that
the physician had issued prescriptions for carisoprodol, my discussion
of the lawfulness of his prescribing practices was based solely on his
controlled substance prescriptions. See 73 FR at 30642-43. In short,
DEA has never held that a practitioner's prescribing practices with
respect to non-controlled substances provide an independent basis for
concluding that the practitioner has engaged in conduct which may
threaten public health and safety and has thus committed acts
inconsistent with the public interest.
This is for good reason as the CSA does not grant this Agency the
sweeping authority suggested by the ALJ's decision and, in particular,
by his reasoning that prescribing a drug for a non-approved use
constitutes ``a dangerous prescribing practice.'' ALJ at 31. As the
Supreme Court explained in Gonzales, the CSA and its case law ``amply
support the conclusion that Congress regulates medical practice insofar
as it bars doctors from using their prescription-writing powers as a
means to engage in illicit drug dealing and trafficking as
conventionally understood. Beyond this, however, the statute manifests
no intent to regulate the practice of medicine generally[,]'' an
authority which remains vested in the States. 546 U.S. at 270.
Moreover, to the extent the ``[t]he CSA allocates decision making
powers among statutory actors * * * medical judgments, if they are to
be decided at the federal level and for the limited objects of the
statute, are placed in the hands of the Secretary.'' Id. at 265.\14\
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\14\ See also 546 U.S. at 268 (``Under the Government's theory,
* * * the medical judgments the Attorney General could make are not
limited to physician-assisted suicide. Were this argument accepted,
[the Attorney General] could decide whether any particular drug may
be used for any particular purpose, or indeed whether a physician
who administers any controversial treatment could be
deregistered.'').
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It is acknowledged that the medical judgment at issue here--the
propriety of prescribing HGH for anti-aging purposes--may have already
been decided by Congress. See 21 U.S.C. 333; but see United States ex
rel. Rost v. Pfizer, Inc., 507 F.3d at 723 (dictum stating that
``[p]hysicians may prescribe Genotropin for non-FDA-approved
indications, but the Food, Drug & Cosmetic Act * * * prohibits
pharmaceutical companies from marketing drugs for such `off-label'
uses''). Yet neither the Government nor the ALJ cited any judicial
authority definitively construing the statute as prohibiting a
physician from prescribing HGH for anti-aging purposes. Likewise,
neither the Government nor the ALJ cite any definitive construction of
the Food, Drug and Cosmetic Act (FDCA) by the Secretary or her
authorized delegatee holding that a physician who acts in good faith
violates 21 U.S.C. 333(e) if he prescribes HGH for anti-aging purposes.
In any event, what is clear is that because DEA is not charged with
administering the FDCA, I have no authority to definitively interpret
that statute, and/or to declare the practice of prescribing HGH for
anti-aging purposes to be a violation of Federal law. Accordingly, the
propriety of Respondent's prescribing of HGH is outside of the Agency's
authority to adjudicate.\15\
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\15\ The Government does not cite any judicial authority
establishing that the issuance of a prescription for a non-FDA
approved drug, which is made in a foreign country, by itself,
constitutes a violation of Federal law. Nor does this case raise the
question of whether a criminal conviction for either illegally
distributing or importing (or conspiring to distribute or import) a
non-controlled drug such as HGH can be considered under Factor Five.
---------------------------------------------------------------------------
However, DEA has long held that a practitioner's self-abuse of a
controlled substance is a relevant consideration under factor five and
has done so even when there is no evidence that the registrant abused
his prescription writing authority. Trawick, 53 FR at 5326. Moreover,
DEA has revoked registrations and/or denied applications for a
registration even where there is no evidence that the practitioner
committed acts involving unlawful distribution to others. See, e.g.,
Kenneth Wayne Green, Jr., 59 FR 51453 (1994); Allan L. Gant, 59 FR
10826 (1994); William H. Carranza, 51 FR 2771 (1986).
As found above, in December 2007, Respondent gave a urine sample
which twice tested positive for cocaine. As the ALJ noted, Respondent
did not challenge either the chain of custody for his sample or the
validity of the procedures used by the labs which tested his samples.
Nor did he put on any evidence pertaining to the rate of false
positives using the labs' testing procedures. Instead, he twice
submitted hair samples. While his hair samples were negative, as the
Government's expert testified, these tests neither confirm nor refute
the urinalysis results. Accordingly, substantial evidence supports the
conclusion that he ingested cocaine in December 2007.
In his testimony, Respondent maintained that it would not make
sense for him to relapse with only eight months remaining on the Agreed
Order
[[Page 49990]]
and raised the Lays' defense that there is no such thing as just one
line of cocaine. Respondent also contended that he had been subjected
to some 400 other tests, which he implied that he had passed.
The short answer to these contentions is that none of them refute
the urinalysis results.\16\ Rather, what Respondent's testimony
suggests is that he still has a problem with cocaine abuse which he
refuses to acknowledge.
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\16\ While Respondent may have taken 400 tests during the period
of the Agreed Order, as found above, he also tested positive for
cocaine in October 2003, as well as alcohol (which he was also
prohibited from consuming under the Agreed Order) in March 2005, and
had also failed to call in to determine whether he was required to
submit a sample.
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It is acknowledged that after his positive test result, Respondent
procured several letters (including two from psychiatrists who treated
him) which supported his continued licensure. However, none of the
letters' authors testified in this proceeding. Accordingly, the basis
of their opinions was not subject to cross-examination. Moreover, each
of the letters from Respondent's treating psychiatrists raises issues
as to the basis for their respective opinions. For example, while Dr.
Crowder's letter stated that Respondent had visited him eleven times
since July 22, 2005, and that ``[d]uring this entire time, I have never
noted any evidence of substance abuse, intoxication or withdrawal on
mental status examination,'' RX 9, Dr. Crowder did not indicate when he
had last examined Respondent. And as Dr. Crowder acknowledged in his
letter: ``Of course, I cannot know whether he [Respondent] has been
honest with me or returned to cocaine use.'' Id. Moreover, Dr. Crowder
acknowledged that he was ``speaking from a limited perspective.''
Id.\17\ Thus, his letter does not establish that Respondent has
successfully rehabilitated himself.
---------------------------------------------------------------------------
\17\ Dr. Crowder also indicated that ``all data available to
[him] indicate that [Respondent's] trace positive result in December
was a false positive.'' RX 9. Putting aside that the result did not
appear to be a trace positive--as it was four times the minimum
detection limit using the GC/MS Confirmation, see GX 8, at 5; Dr.
Crowder did not explain exactly what data he reviewed and whether it
included any of the data from the actual lab tests of Respondent's
urine sample.
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Dr. Bailey's letter stated that he had performed a psychiatric
evaluation of Respondent on February 11, 2008, and found that his
``mental status is within normal limits'' and that ``there is no
current impairment.'' RX 10. Dr. Bailey also found that Respondent's
``[c]ocaine dependence [was] in remission,'' and he planned to release
Respondent from his care. Id. However, there is no indication in the
letter that Dr. Bailey was aware of Respondent's failed drug test from
two months earlier, which would seem to be critical information for
determining whether his cocaine dependence is in remission.
Accordingly, while this letter is somewhat more probative of
Respondent's condition, I conclude that it is not dispositive of
whether he has a continuing problem with cocaine abuse.\18\
---------------------------------------------------------------------------
\18\ Having reviewed the letter from Dr. Chancellor on behalf of
the Physician Recovery Committee, I conclude that it does not
constitute a clinical evaluation of Respondent's condition and give
it no weight.
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In any event, the record establishes that Respondent has illicitly
used cocaine on at least three separate occasions including once in the
recent past and that he has also abused alcohol in violation of the
Board's order. Moreover, the record also establishes that Respondent
lied to the State Board and went so far as to produce a false written
statement that his positive test was the result of his ex-girlfriend's
having spiked a drink. Given this record, the ALJ's skepticism of
Respondent's rehabilitative efforts was entirely warranted.
Furthermore, Respondent's cocaine abuse provides reason alone to
conclude that he has committed acts which render his continued
registration inconsistent with the public interest and which justify
the revocation of his registration.\19\
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\19\ There is also evidence that Respondent practiced at various
locations without updating his registration to reflect that he was
doing so. However, under DEA's regulation, a practitioner is not
required to obtain a registration for ``[a]n office used by a
practitioner (who is registered at another location in the same
State * * *) where controlled substances are prescribed but neither
administered nor otherwise dispensed as a regular part of the
professional practice of the practitioner at such office, and where
no supplies of controlled substances are maintained.'' 21 CFR
1301.12(b)(3) (emphasis added).
With the exception of the Spa 02 clinic, the Government produced
no evidence that he did anything other than write prescriptions at
these offices. Although there is evidence that Respondent
administered testosterone at the Spa 02 clinic, the only evidence of
this activity produced by the Government pertains to a single
patient, R.G. While there was evidence to the effect that the
administrations occurred either once a month or every two weeks at
most, Tr. 114, the Government produced only a single testosterone
prescription written by Respondent for R.G. and did not introduce
his medical record. Thus, the evidence does not establish the
duration of Respondent's administration of testosterone to him.
Furthermore, the evidence suggests that R.G. brought the
testosterone with him to the clinic and there is no evidence that
Respondent maintained supplies of any controlled substance at the
clinic. The Government has therefore failed to show that Respondent
administered controlled substances ``as a regular part of [his]
professional practice'' at this office. 21 CFR 1301.12(b)(3). I
therefore hold that Respondent was not required to be registered at
this location.
Moreover, the Government produced no evidence to refute
Respondent's testimony that while he was moonlighting at these other
offices, he was mainly practicing at the MacArthur office. Thus, it
is clear that he was registered within the State of Texas and was in
compliance (based on this record) with the regulation. The
allegation therefore fails.
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``Proceedings under sections 303 and 304 of the CSA, however, are
non-punitive.'' Samuel S. Jackson, 72 FR 23848, 23853 (2007) (citing
Leo R. Miller, 53 FR 21931, 21932 (1988)). DEA has repeatedly
recognized that ``this proceeding `is a remedial measure, based upon
the public interest and the necessity to protect the public from those
individuals who have misused controlled substances or their DEA
Certificate of Registration, and who have not presented sufficient
mitigating evidence to assure the Administrator that they can be
[en]trusted with the responsibility''' that attaches with a
registration. Id. (quoting 53 FR at 21932).
Consistent with these principles, where the only misconduct proved
on the record involves self-abuse, this Agency has frequently granted a
new registration to those practitioners who undergo treatment and
thereafter demonstrate their continued sobriety. See Steven M.
Abbadessa, 74 FR 10077 (2009); Scott H. Nearing, 70 FR 33200 (2005);
Vincent J. Scolaro, 67 FR 42060 (2002). Therefore, while I revoke
Respondent's registration, I further hold that in the event he
undergoes inpatient treatment for his substance abuse problem,
demonstrates his continued sobriety for a period of one year from the
effective date of this Order, and does not engage in any other
misconduct related to controlled substances during this period,\20\
favorable consideration should be given to an application for a new
registration which is submitted at the conclusion of this period.
Moreover, as a condition of receiving a new registration, Respondent
must agree to undergo random drug testing for a period of three years
which shall begin on the date any new registration is issued to him.
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\20\ To make clear, Respondent (and not this Agency) is
responsible for the costs of any treatment program as well as
demonstrating his sobriety including drug testing both before and
during the period of any new registration.
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Order
Pursuant to the authority vested in me by 21 U.S.C. 823(f) &
824(a)(4), as well as 28 CFR 0.100(b) & 0.104, I order that DEA
Certificate of Registration, BB8997857, issued to Tony T. Bui, M.D.,
be, and it hereby is, revoked. I further order that any pending
application to renew or modify the registration be, and it hereby is,
denied.
[[Page 49991]]
This order is effective September 15, 2010.
Dated: July 30, 2010.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. 2010-20242 Filed 8-13-10; 8:45 am]
BILLING CODE 4410-09-P