Registrant Actions - 2012
[Federal Register Volume 77, Number 113 (Tuesday, June 12, 2012)]
[Notices]
[Pages 35028-35031]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-14316]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Bill Alexander, M.D.; Decision and Order
On September 22, 2011, the Deputy Assistant Administrator, Office
of Diversion Control, Drug Enforcement Administration, issued an Order
To Show Cause to Bill Alexander, M.D. (Applicant), of Porter, Texas.
The Show Cause Order proposed the denial of Applicant's application for
a DEA Certificate of Registration as a practitioner in schedules II
through V, on the ground that his "registration would be inconsistent
with the public interest." Show Cause Order at 1 (citing 21 U.S.C.
823(f) and 824(a)(4)).
The Show Cause Order alleged that on December 3, 2010, Applicant
applied for a practitioner's registration in schedules II-V at the
location of 24420 FM 1314, Suite 101, Porter, Texas. Id. The Show Cause
Order then alleged that on or about June 18, 2009, Applicant unlawfully
possessed 64 kilograms of marijuana, a schedule I controlled substance,
in violation of both federal and state law. Id. at 2 (citing 21 U.S.C.
841(a)(1) and Texas Health & Safety Code Ann. 481.121(b)(5)).
Next, the Show Cause Order alleged that on or about June 18, 2009,
Applicant told law enforcement agents that he was transporting the
marijuana for a drug dealer, and that he had transported over a dozen
such loads of marijuana in the past. Id. The Order further alleged that
Applicant told the agents that he was addicted to and used crack
cocaine, a schedule I controlled substance.\1\ Id.
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\1\ Under federal law, crack cocaine is a schedule II controlled
substance. 21 CFR 1308.12(b)(4).
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The Show Cause Order also alleged that on or about February 4,
2011, the Texas Medical Board entered a Corrective Order against
Applicant's medical license. Id. According to the
[[Page 35029]]
allegations, the Texas Board found that Applicant prescribed controlled
substances to individuals without holding a valid Texas Controlled
Substances Registration, in violation of state law. Id. (citing Tex.
Health & Safety Code Ann. 481.061(a)).
The Show Cause Order further alleged that during various interviews
with DEA Investigators, Applicant stated his desire to open a pain
management clinic in order to make money. Id. According to the
allegations, Applicant stated his "belief that the purpose of a pain
management clinic was to give addicts their prescriptions because other
doctors won't do it." Id.
The Show Cause Order, which also notified Applicant of his right to
request a hearing on the allegations or to submit a written statement
in lieu of a hearing, the procedure for doing either, and the
consequence for failing to do either, id. at 2 (citing 21 CFR 1301.43),
was served on Applicant by registered mail addressed to him at the
address he provided on his application. While the return receipt card
did not include a delivery date, Applicant subsequently confirmed to
Government Counsel that he received the Order on September 26, 2011. GX
4; Request for Final Action, at 2.
Since the date of service of the Order, thirty days have now passed
and neither Applicant, nor anyone purporting to represent him, has
requested a hearing or submitted a written statement in lieu of a
hearing. I therefore find that Applicant has waived his right to a
hearing or to submit a written statement in lieu of a hearing, and
issue this Decision and Final Order based on relevant evidence
contained in the record submitted by the Government. 21 CFR 1301.43(d)
and (e). I make the following additional findings of fact.
Findings
Applicant's Licensure and Registration Status
Applicant is a physician licensed by the Texas Medical Board
(hereinafter, the Board). GX 6. On February 4, 2011, a Quality
Assurance Panel of the Board issued a Corrective Order to Applicant.
Id. Therein, the Board found that notwithstanding that Applicant had
allowed his Texas Controlled Substance Registration to expire on
October 31, 2008, he had continued to write prescriptions for
controlled substances through October 21, 2009, when his state license
was renewed. Id. The Order imposed an administrative penalty in the
amount of $500 against Applicant. Id. at 1-2 (citing Tex. Occ. Code
Ann. 164.002(a) and (d), and 164.053(a)(1)).
Applicant previously held DEA Certificate of Registration
BA0549177, which authorized him to dispense controlled substances in
schedules II through V, as a practitioner, at the registered location
of 1406 Wilson Road, Conroe, TX 77304. GX 2. This registration expired
by its terms on June 30, 2003. Id.
On March 30, 2004, Applicant was granted Certificate of
Registration BA8721765, which also authorized him to dispense
controlled substances in schedules II through V, as a practitioner, at
the registered location of 350 South Adams, Eagle Pass, TX 78852. This
registration expired by its terms on June 30, 2010. Id.
On December 3, 2010, Applicant submitted a new application for a
practitioner's registration in schedules II through V, through the
Office of Diversion Control's Web site. It is this application which is
at issue in this proceeding.
Evidence Regarding the Substantive Allegations
On June 18, 2009, following a traffic stop, Applicant was arrested
by a Texas Highway Patrol Officer for possession of marijuana, a
schedule I controlled substance. GX 5. At the time of his arrest, the
Trooper conducted a consensual search of Applicant's vehicle, during
which he found two large black suitcases which contained marijuana and
a small black toiletry bag which contained several homemade smoking
pipes. Id. at 4-5. Regarding the pipes, which the Trooper identified as
drug paraphernalia, the Trooper asked Applicant what he used them for;
Applicant stated: "To smoke." Id. The Trooper then asked Applicant
what he smoked; Applicant replied: "Crack," which is a schedule II
controlled substance. Id. Respondent was then arrested; however, he was
not criminally charged.
On December 6, 2010, a DEA Diversion Investigator (DI) began an
investigation of Applicant's December 3, 2010 application for a DEA
registration. GX 7 (DI's affidavit). According to the DI's affidavit,
because Applicant cooperated with another ongoing law enforcement
investigation, he was never criminally charged in connection with his
arrest for possession of marijuana on June 18, 2009. Id.
The DI stated that during a phone conversation on January 11, 2011,
Applicant admitted that at the time of his June 2009 arrest, which he
characterized as a mistake, he was transporting marijuana for a drug
trafficking organization because he needed the money. Id. at 2.
Applicant told the DI he planned to open a medical clinic, with other
practitioners, which would specialize in orthopedic surgery and pain
management. Id. He stated that his desire to open a pain management
clinic was only because he wanted to make money and that he would "do
anything to make money." Id.
During a subsequent in-person interview, Applicant told the DIs
that he closed his last medical practice, an orthopedic surgery center,
in 2008. Id. He also admitted that he had abused crack cocaine in the
past, but had stopped using crack cocaine in 2009 after having a heart
attack. Id. However, Applicant never underwent a drug treatment
program. Id.
Applicant told the DIs that after closing his medical practice in
late 2008, he agreed to transport marijuana for a drug organization.
Id. Applicant admitted to having driven loads of marijuana from Eagle
Creek or Del Rio, Texas to either San Antonio or Austin because he was
having financial problems and he would " 'do anything not to lose
[his] property.' " Id. He also admitted that he transported such loads
approximately every other weekend from the end of 2008 until he was
arrested in June 2009, but he was uncertain as to the exact number of
loads he had delivered. Id. at 2-3. Applicant stated that he was paid
$50 per pound, and that he usually received $3,000 to $5,000 per load
of marijuana. Id. at 3.
Applicant told the DIs that he only wanted to open a pain clinic to
share the overhead costs of a medical clinic with other practitioners,
that he did not have any formal pain management training, and that he
" 'hated those kinds of patients.' " Id. at 3. Moreover, he then
stated that pain management clinics were good because they served
individuals who were addicted to pain medication without " 'bogging
down other clinics asking for pain pills.' " Id. When asked by the DIs
what he would do when he had twenty patients waiting for their
prescriptions, Applicant responded that " 'if their doctors gave them
a prescription and they're hooked, if they're a functioning patient,
probably give it to them. What else are you gonna [sic] do with them?'
" Id.
Upon being told by the DI that she was recommending the denial of
his application based on his previous involvement with transporting
large quantities of marijuana and his intention to open a pain clinic,
Applicant asked the DI if she thought that " 'there's a proper way' "
to manage a pain clinic and make sure everything was done correctly.
Id. When the DI said
[[Page 35030]]
that she did not think it was proper to provide prescriptions to
addicts, Applicant replied: " 'What do you think pain management
clinics are for? They give addicts their prescriptions because other
doctors won't do it!' " Id. at 3-4.
Discussion
Section 303(f) of the Controlled Substances Act (CSA) provides that
an application for a practitioner's registration may be denied upon a
determination "that the issuance of such registration would be
inconsistent with the public interest." 21 U.S.C. 823(f). In making
the public interest determination in the case of a practitioner,
Congress directed that the following factors be considered:
(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.
"[T]hese factors are considered in the disjunctive." Robert A.
Leslie, 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 * * * to deny an application." Id.;
see also Volkman v. DEA, 567 F.3d 215, 222 (6th Cir. 2009). While I
must consider each factor, I am "not required to make findings as to
all of the factors." MacKay v. DEA, 664 F.3d 808, 816 (10th Cir.
2011); Hoxie v. DEA, 419 F.3d 477, 482 (6th Cir. 2005).
With respect to a practitioner's registration, the Government has
the burden of proving by substantial evidence that granting a
registration would be inconsistent with the public interest. See 21 CFR
1301.44(d).\2\ As no DEA regulation provides that the entry of a
default is a consequence of the waiver of the right to a hearing, the
Government must therefore support its proposed action with substantial
evidence.
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\2\ As found above, Applicant neither requested a hearing nor
submitted a written statement explaining his position on the matters
of fact and law asserted. By contrast, in a contested case, where
the Government satisfies its prima facie burden, as for example, by
showing that an applicant has committed acts which are inconsistent
with the public interest, the burden then shifts to the Applicant to
demonstrate why he can be entrusted with a registration. Medicine
Shoppe-Jonesborough, 73 FR 363, 387 (2008).
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In this matter, I have considered all of the factors and conclude
that the evidence relevant to Respondent's experience in dispensing
controlled substances (factor two), his compliance with applicable laws
related to controlled substances (factor four), and his having engaged
in other conduct which may threaten the public health and safety
(factor five), conclusively establishes that granting his application
would be "inconsistent with the public interest." 21 U.S.C. 823(f).
Factors One and Three--The Recommendation of the State Licensing Board
and the Applicant's Conviction Record Under Federal or State Laws
Relating to the Manufacture, Distribution or Dispensing of Controlled
Substances
As found above, the Board found that Applicant dispensed controlled
substances for nearly a year without the requisite State controlled
substance registration. However, the Board took no action against
Applicant's medical license other than to impose a $500 administrative
penalty and he thus retains an active State medical license. Also,
Applicant apparently still holds a valid Texas Controlled Substance
Registration.
However, while the CSA makes holding authority to dispense
controlled substances a condition of obtaining a DEA registration, it
is not dispositive of the public interest inquiry. Rather, in enacting
the public interest amendments to the CSA, Congress vested this Agency
with "a separate oversight responsibility [apart from that which
exists in State authorities] with respect to the handling of controlled
substances." Mortimer B. Levin, 55 FR 8209, 8210 (1990). DEA has
therefore long recognized that it has "a statutory obligation to make
its independent determination as to whether the granting of [a
registration] would be in the public interest." Id. Accordingly, "DEA
has long held * * * that a State's failure to take action against an
Applicant's medical license [or State controlled substance
registration] is not dispositive in determining whether the
continuation of a registration is in the public interest." Jayam
Krishna-Iyer, 74 FR 459, 461 (2009); see also Levin, 55 FR at 8210
(holding that practitioner's reinstatement by state board "is not
dispositive" in public interest inquiry). Thus, that neither the Texas
Medical Board nor Texas Department of Public Safety has suspended or
revoked Applicant's medical license or controlled substance
registration is of no consequence in determining whether his continued
registration is consistent with the public interest.
Likewise, the fact that Applicant has not been convicted of an
offense falling within factor three, notwithstanding his arrest and
admission that on numerous occasions he transported large quantities of
marijuana for a drug trafficking organization, is not dispositive. As
previously explained, and as this case demonstrates, there are a
variety of reasons why a person who has engaged in criminal conduct may
not have been convicted, let alone charged with a criminal offense. See
Dewey C. MacKay, 75 FR 49956, 49973 (2010). Accordingly, I find that
factor three is not dispositive of whether granting Applicant's
application would be consistent with the public interest.
Factors Two and Four--Applicant's Experience in Dispensing Controlled
Substances and Record of Compliance With Applicable Controlled
Substance Laws
The Texas Board found that Applicant allowed his Texas Controlled
Substance Registration to expire on October 31, 2008, and yet continued
to write controlled substance prescriptions in violation of Texas law
until he renewed his license on October 21, 2009. GX 6, at 1-2. This
was also a violation of federal law.
Under a DEA regulation, "[a] prescription for a controlled
substance may be issued only by an individual practitioner who is * * *
authorized to prescribe controlled substances by the jurisdiction in
which he is licensed to practice his profession." 21 CFR
1306.03(a)(1). By issuing prescriptions when he did not possess state
authority, Respondent thus violated the CSA as well. See 21 U.S.C.
841(a)(1) ("Except as authorized by this subchapter, it shall be
unlawful for any person knowingly or intentionally * * * to * * *
dispense * * * a controlled substance[.]").
In addition, Applicant admitted to the DIs that on numerous
occasions, he illegally transported large quantities of marijuana for a
drug trafficking organization and was paid to do so. GX 7, at 2-3. This
conduct also violated 21 U.S.C. 841(a)(1), which prohibits both the
knowing or intentional distribution of a controlled substance, as well
as the possession of a controlled substance with the intent to
distribute.
Finally, Applicant admitted that he abused crack cocaine. GX 7, at
2. This conduct violated 21 U.S.C. 844(a), which makes it "unlawful
for any person knowingly or intentionally to possess a controlled
substances unless
[[Page 35031]]
such substance was obtained directly, or pursuant to a valid
prescription or order, from a practitioner, while acting in the course
of his professional practice, or except as authorized by" the CSA or
the Controlled Substances Import Export Act. In addition, Respondent's
conduct violated various provisions of state law. See Tex. Health &
Safety Code 481.115(a) and 481.121(b)(5). Thus, the evidence with
respect to factors two and four provides ample reason to deny
Applicant's application.\3\
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\3\ As evidence of his likely non-compliance with applicable
laws related to controlled substances, I note that during his
interviews with DEA Investigators regarding the purpose of his
proposed registration, Applicant stated that he wanted to open a
pain clinic "only because he wanted to make money, and that he
would do anything to make money." Id. at 2. Moreover, Applicant
expressed the view that pain clinics were good because they served
individuals who were addicted to pain medication without "bogging
down other clinics asking for pain pills." GX 7, at 3.
Subsequently, Applicant stated "what do you think pain management
clinics are for? They give addicts their prescriptions because other
doctors won't do it!" Id. at 3-4. Putting aside the misconduct
proven on this record, Applicant's comments do not inspire
confidence that he would comply with federal requirements such as 21
CFR 1306.04(a), which requires that a prescription for a controlled
substance be issued only for a legitimate medical purpose by a
practitioner acting in the usual course of professional practice.
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Factor Five--Such Other Conduct Which May Threaten the Public Health
and Safety
As found above, during the consensual search of Applicant's
vehicle, a Texas Highway Patrol Officer found several home-made pipes,
and upon being questioned as to what he used them for, Applicant
admitted that he smoked crack cocaine. Also, Applicant admitted to DEA
Investigators that he had previously abused crack cocaine. While
Applicant later claimed that he had stopped using crack after suffering
a heart attack, he also stated that he never underwent drug
rehabilitation treatment.
DEA has "long held that a practitioner's self-abuse of a
controlled substance can be considered under Factor Five even if there
is no evidence that [he] abused his prescription-writing authority or
otherwise engaged in an unlawful distribution to others." See Scott D.
Fedosky, 76 FR 71375, 71378 (2011). See also Tony T. Bui, 75 FR 49979,
49989-90 (2010) (collecting cases); David E. Trawick, 53 FR 5326, 5327
(1988). Thus, even if there was no other evidence of misconduct on the
part of Applicant, his self-abuse of crack cocaine would by, itself,
constitute conduct which threatens public health and safety and renders
his proposed registration "inconsistent with the public interest."
Id. 823(f).
Conclusion
Based on Applicant's misconduct in issuing prescriptions without
the requisite state authority, see 21 CFR 1306.03(a), his admitted
transportation of marijuana for a drug trafficking organization, see 21
U.S.C. 841(a)(1), and his self-abuse of crack cocaine, I conclude that
Applicant's registration would be "inconsistent with the public
interest." Id. 823(f). Accordingly, his application will be denied.
Order
Pursuant to the authority vested in me by 21 U.S.C. 823(f), as well
as 28 CFR 0.100(b), I order that the application of Bill Alexander,
M.D., for a DEA Certificate of Registration, be, and it hereby is,
denied. This Order is effective immediately.
Dated: June 2, 2012.
Michele M. Leonhart,
Administrator.
[FR Doc. 2012-14316 Filed 6-11-12; 8:45 am]
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