[Federal Register Volume 78, Number 204 (Tuesday, October 22, 2013)]
[Notices]
[Pages 62676-62678]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-24694]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Anthony E. Wicks, M.D. Decision and Order
On June 6, 2012, the Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement Administration, issued an Order to
Show Cause to Anthony E. Wicks, M.D. (Applicant), of Tampa, Florida.
Show Cause Order at 1. The Show Cause Order proposed the denial of
Applicant's application for a DEA Certificate of Registration, because
granting his application would be ``inconsistent with the public
interest.'' See id.; 21 U.S.C. 823(f).
The Show Cause Order specifically alleged that in approximately
December 2010, Applicant discontinued his practice in Visalia,
California and began practicing in Winter Springs, Florida, and that he
issued more than 2,290 controlled-substance prescriptions without being
registered at this location, in violation of 21 U.S.C. 822(e) and 21
CFR 1301.12; and that he also failed to notify DEA of the change in his
practice location pursuant to 21 CFR 1301.51. Show Cause Order at 1.
The Show Cause Order also alleged that after Applicant's registration
expired on May 31, 2011, he issued more than 270 controlled-substance
prescriptions, in violation of 21 U.S.C. 841(a) and 843(a)(2). Id. at
2.
The Show Cause Order further notified Applicant that within thirty
days of the date of his receipt of the Order, he had the right to
either request a hearing, or to file a waiver of his right to a
hearing, together with a written statement of his position on the
matters of fact and law asserted by the Government. Id. (citing 21 CFR
1301.43(a) & (c)). In addition, the Order notified applicant that
should he ``request a hearing and then fail to appear at the . . .
hearing, [he would] be deemed to have waived his right to a hearing''
and that a final order may be entered ``without a hearing based upon
the evidence presented to'' me. Id. (citing 21 CFR 1301.43(d) & (e)).
The Government served the Show Cause Order on Applicant by
certified mail addressed to him at the address of his proposed
registered location. GXs 1, 16, 17. As evidenced by the signed return
receipt card, service was accomplished on June 9, 2012. GX 17.
On July 5, 2012, Applicant, through his counsel, filed a timely
request for a hearing. GX 18. The matter was placed on the docket of
the Office of Administrative Law Judges (ALJ) and assigned to an ALJ,
who proceeded to conduct pre-hearing procedures. GX 22. However, on
September 26, 2012, Applicant withdrew his request for a hearing. GX
21. The same day, the ALJ issued an Order granting Applicant's request
and cancelled the hearing. GX 22.
On March 13, 2013, the Government submitted the Investigative
Record and a Request for Final Agency Action to my Office. As an
initial matter, I find that Applicant, by withdrawing his request for a
hearing, has waived his right to a hearing on the allegations. See 21
CFR 1301.43(d). I therefore issue this Decision and Order based on
relevant evidence found in the Investigative Record submitted by the
Government. See id. 1301.43(e). I make the following findings.
Findings
Applicant previously held DEA Certificate of Registration
BW7987184, which authorized him to dispense controlled substances in
Schedules II through V, as a practitioner, at the registered address of
400 West Mineral King Blvd., Department of Anesthesia, Visalia,
California.\1\ GX 2. This registration was issued on April 11, 2008 and
expired on May 31, 2011. Id. While Applicant was sent two renewal
notices, as well as a delinquency notice (after his registration had
expired), he failed to renew the registration, and on
[[Page 62677]]
July 1, 2011, it was retired by the Agency. GX 3, at 1; GX 15, at 3, ]
11.
---------------------------------------------------------------------------
\1\ Applicant had also previously held a registration which
authorized him to dispense controlled substances at the registered
location of: Department of Anesthesia, St. Joseph's Hospital, 1105
Shipwatch Circle, Tampa, Florida. GX 4, at 1. This registration
expired on May 31, 2005 and was retired when Applicant failed to
renew it. Id. at 2.
---------------------------------------------------------------------------
On July 19, 2011, Applicant applied for a new registration. GX 1.
Applicant sought authority to dispense controlled substances in
Schedules II--V at the registered address of 1105 Shipwatch Circle,
Tampa, Florida. Id.
A Diversion Investigator (DI) subsequently determined that
beginning in December 2010, Applicant had begun practicing at a pain
clinic located in Winter Springs, Florida. GX 15. However, Applicant
neither obtained a registration for this location, nor sought to modify
the address of his then-existing registration. Instead, during the
ensuing period, which lasted through at least most of June 2011,
Applicant issued 3,120 controlled-substance prescriptions,\2\ using DEA
registration BW7987184, while listing his address as Pain Management of
Winter Springs, 165 W. SR 434, Winter Springs, Florida. GX 15, at 2, ]]
5-6. Applicant never notified the Agency that he had changed his
practice address. Id. at 2, ] 5.
---------------------------------------------------------------------------
\2\ Documentary evidence, which the Government acquired through
administrative subpoena, includes copies of some of the
prescriptions Respondent wrote for controlled substances while
practicing at the Winter Springs pain clinic. See GXs 7-11.
Walgreens' and Albertsons' pharmacies provided the documents. Id.
Additionally, Walgreens provided a chart summarizing all of
Applicant's prescriptions that were filled at their pharmacies after
he started practicing at the Winter Springs pain clinic. See GX 14.
---------------------------------------------------------------------------
The DI also found that Applicant had issued at least 341 \3\
controlled-substance prescriptions after his registration had expired.
GX 15, at 2, ] 7; see also GX 13. Applicant wrote the prescriptions for
oxycodone,\4\ diazepam, and lorazepam.\5\ GX 15, at 2, ] 7; GX 13.
---------------------------------------------------------------------------
\3\ The documentary evidence offered by the Government in
support of this figure is contained within GX 13. This exhibit
contains 439 pages of documents which were obtained from Walgreens;
however, the exhibit contains prescriptions, as well as the labels
that were generated for the prescriptions and which are typically
placed in the pharmacy's dispensing log. However, even if this
exhibit does not support the exact number of controlled substance
prescriptions Applicant issued as alleged by the DI, it still
provides evidence that he issued several hundred prescriptions after
the expiration of his registration. Moreover, in Holiday CVS,
L.L.C., d/b/a CVS/Pharmacy Nos. 219 and 519, 77 FR 62315, 62316,
62328 (2012), I adopted the ALJ's finding that these stores had
dispensed a total of 55 controlled-substance prescriptions for
oxycodone 30mg, which Applicant issued after the expiration of his
registration.
\4\ Oxycodone is a schedule II controlled substance. See 21 CFR
1308.12(b)(1).
\5\ Both Diazepam (Valium) and Lorazepam (Ativan) are schedule
IV depressants. 21 CFR 1308.14(c).
---------------------------------------------------------------------------
Discussion
Under the Controlled Substances Act (CSA), an application for a
practitioner's registration may be denied if ``the issuance of such
registration . . . would be inconsistent with the public interest.'' 21
U.S.C. 823(f). In making the public interest determination, 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, or conducting
research with respect to controlled substances;
(3) The applicant's conviction record under Federal or State
laws relating to the manufacture, distribution, or dispensing of
controlled substances;
(4) Compliance with applicable State, Federal, or local laws
relating to controlled substances; and
(5) Such other conduct, which may threaten the public health and
safety.
21 U.S.C. 823(f).\6\
---------------------------------------------------------------------------
\6\ Pursuant to 21 U.S.C. 871(a), the Attorney General has
delegated this authority to the DEA Administrator. See 28 CFR
0.100(b).
---------------------------------------------------------------------------
``[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 revoke an existing registration
or to deny an application. Id. Moreover, while I ``must consider each
of these factors, [I] `need not make explicit findings as to each
one.''' MacKay v. DEA, 664 F.3d 808, 816 (10th Cir. 2011) (quoting
Volkman v. DEA, 567 F.3d 215, 222 (6th Cir. 2009)); see also Hoxie v.
DEA, 419 F.3d 477, 482 (6th Cir. 2005) (citing Morall v. DEA, 412 F.3d
165, 173-74 (D.C. Cir. 2005)).
The Government has ``the burden of proving that the requirements
for . . . registration . . . are not satisfied.'' 21 CFR 1301.44(d). In
this matter, I have considered all of the factors and conclude that the
evidence with respect to factors two and four supports the conclusion
that granting the application ``would be inconsistent with the public
interest.'' \7\ 21 U.S.C. 823(f).
---------------------------------------------------------------------------
\7\ It is acknowledged that the Government offered no evidence
regarding factors one, three, and five. While I have assumed that
there is no evidence under any of these three factors that would
support the denial of Applicant's application, the Agency has held
that findings under a single factor can support the denial of an
application. See MacKay, 664 F.3d at 817-18 (quoting Dewey C.
MacKay, 75 FR 49956, 49973 (2010)); see also Hoxie v. DEA, 419 F.3d
477, 482 (6th Cir. 2005); Jayam Krishna-Iyer, 74 FR 4590, 462
(2009).
---------------------------------------------------------------------------
Factors Two and Four--Respondent's Experience in Dispensing Controlled
Substances and Compliance with Applicable Federal and State Laws
Related to Controlled Substances
A. The Applicant's Issuance of Prescriptions at an Unregistered
Location
Under the CSA, ``[e]very person who dispenses \8\ . . . any
controlled substance, shall obtain from the Attorney General a
registration issued in accordance with the rules and regulations
promulgated by him.'' 21 U.S.C. 822(a)(2). Moreover, ``[a] separate
registration [is] required at each principal place of business or
professional practice where the applicant . . . dispenses controlled
substances.'' Id. Sec. 822(e); see 21 CFR 1301.12(a).
---------------------------------------------------------------------------
\8\ See 21 U.S.C. Sec. 802(10) (``The term `dispense' means 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 . . ..'').
---------------------------------------------------------------------------
In a rulemaking, DEA has explained that ``DEA individual
practitioner registrations are based on a [s]tate license to practice
medicine and prescribe controlled substances.'' DEA, Clarification of
Registration Requirements for Individual Practitioners, 71 FR 69478
(2006) (final rule); see also 21 U.S.C. 823(f) (``The Attorney General
shall register practitioners . . . to dispense . . . controlled
substances . . . if the applicant is authorized to dispense . . .
controlled substances under the laws of the State in which he
practices.'').\9\ Therein, the Agency further explained that ``[s]tate
authority to conduct the above-referenced activities only confers
rights and privileges within the issuing State; consequently, the DEA
registration based on a [s]tate license cannot authorize controlled
substance dispensing outside the State.'' 71 FR at 69478.
---------------------------------------------------------------------------
\9\ See also 21 U.S.C. Sec. 802(21) (defining ``[t]he term
`practitioner' [as] a physician . . . licensed, registered, or
otherwise permitted, by the United States or the jurisdiction in
which he practices . . . to . . . dispense . . . a controlled
substance in the course of professional practice''); id. Sec.
824(a)(3) (authorizing the suspension or revocation of a
registration based ``upon a finding that the registrant . . . has
had his State license or registration suspended, revoked, or denied
by competent State authority and is no longer authorized by State
law to engage in the . . . dispensing of controlled substances'').
---------------------------------------------------------------------------
The evidence shows that Applicant issued thousands of controlled-
substance prescriptions while practicing medicine at the Winter
Springs, Florida pain clinic and did so over the course of a seven-
month period. The evidence thus establishes that Applicant
[[Page 62678]]
maintained a principal place of professional practice at the Winter
Springs pain clinic. Because the evidence further shows that during
this period, Applicant was not registered at this location, or any
other location in the State of Florida, I conclude that Applicant
violated the CSA's separate registration requirement. 21 U.S.C.
822(e).\10\
---------------------------------------------------------------------------
\10\ As support for its contention that, ``[u]nder DEA
regulations, a practitioner is required to report a change of
registered address to DEA,'' the Government cites 21 CFR 823(f)(2).
Request for Final Agency Action, at 6. However, a review of the Code
of Federal Regulations reveals that the provision cited by the
Government does not even exist, and to the extent the Government
mistakenly cited to the Code of Federal Regulations rather than the
United States Code, 21 U.S.C. 823(f)(2) provides no support for its
contention because it is simply a factor to be considered in
determining the public interest and is not an independent
requirement for registration. See Penick Corp., Inc., v. DEA, 491
F.3d 483, 490 (D.C. Cir. 2007) (citation omitted). Indeed, the text
of factor two simply directs the Agency to consider ``[t]he
applicant's experience in dispensing . . . controlled substances''
and imposes (unlike numerous other provisions of the CSA) no
substantive obligation on an applicant or registrant.
---------------------------------------------------------------------------
The CSA further provides that ``[e]very registrant . . . shall be
required to report any change of professional or business address in
such manner as the Attorney General shall by regulation require.'' 21
U.S.C. 827(g). Under a DEA regulation, ``[a]ny registrant may apply to
modify his/her registration . . . to change his/her name or address, by
submitting a letter of request to the Registration Unit, Drug
Enforcement Administration.'' 21 CFR 1301.51. Of consequence, this
regulation further provides that ``[t]he request for modification shall
be handled in the same manner as an application for registration.'' Id.
Moreover, under 21 CFR 1301.13(a), ``[n]o person required to be
registered shall engage in any activity for which registration is
required until the application for registration is granted and a
Certificate of Registration is issued by the Administrator to such
person.''
Because section 827(g) clearly creates a substantive obligation on
the part of a registrant to notify the Agency if he changes his
professional address, the regulation's use of the words ``may apply to
modify'' cannot alter (and cannot reasonably be read as altering) the
binding nature of a registrant's obligation to notify the Agency. Cf.
Chevron, U.S.A., Inc. v. NRDC, 467 U.S. 837, 842-43& n.9 (1984); see
also United States v. Marte, 356 F.3d 1336, 1341 (11th Cir. 2004)
(``When a regulation implements a statute, the regulation must be
construed in light of the statute[.]'') (citation omitted). Indeed,
because the regulation itself further states that a modification is
``handled in the same manner as an application for registration,'' and
thus, a registrant may ``not engage in any activity for which
registration is required until the application . . . is granted and a .
. .[r]egistration is issued,'' 21 CFR 1301.13(a), the regulation is
also properly construed as imposing, on a registrant who changes his
professional address, the binding obligations to both: 1) Notify the
Agency, and 2) refrain from dispensing activities until his request is
approved. Accordingly, I also conclude that Respondent violated the CSA
and DEA regulations when he failed to notify the Agency of the change
of his professional address and yet proceeded to dispense controlled
substances at his new practice location. See 21 U.S.C. Sec. 827(g); 21
CFR 1301.13(a) and 1301.51. These findings, particularly when
considered in light of the extent of the Applicant's violations,
support the conclusion that granting Applicant's application ``would be
inconsistent with the public interest.'' Id. Sec. 823(f).
B. The Applicant's Issuance of Prescriptions After His DEA
Registration Expired
Under the CSA, it is unlawful for a practitioner to ``knowingly or
intentionally . . . use in the course of the distribution[] or
dispensing of a controlled substance, . . . a registration number which
is . . . expired.'' 21 U.S.C. 843(a)(2); see also 21 CFR 1306.03(a)
(``A prescription for a controlled substance may be issued only by an
individual practitioner who is . . . registered . . . .''). Notably, a
DEA Certificate of Registration states on its face the date it expires;
with respect to Applicant, his registration stated that it expired on
May 31, 2011. See GX 2. Moreover, other evidence submitted by the
Government shows that the Agency sent notices (on March 25 and April
10, 2011) to Applicant notifying him of the impending expiration of his
registration. GX 3, at 2.
Here, the evidence shows that while Applicant's registration
expired on May 31, 2011, he nonetheless proceeded to use the
registration to issue several hundred controlled-substance
prescriptions for drugs such as oxycodone 30mg. and Valium 10mg. See GX
13. In the absence of any evidence to the contrary, I further find that
Applicant knew that his registration had expired and thus violated the
CSA and DEA regulations when he continued to use it to issue the
prescriptions. 21 U.S.C. 843(a)(2); 21 CFR 1306.03(a).
Here again, the extent of Applicant's misconduct in using an
expired registration to issue prescriptions provides reason to deny his
application. See Larry E. Davenport, M.D., 68 FR 70534, 70537-38
(2003), pet. for rev. denied Davenport v. U.S. Dep't of Justice, 122 F.
App'x 224 (6th Cir. 2005); James C. LaJevic, D.M.D., 64 FR 55962, 55964
(1999). These violations, coupled with the thousands of violations
Applicant committed in issuing prescriptions at the Winter Springs pain
clinic without being registered at this location, strongly support the
conclusion that granting Respondent's application for a new
registration ``would be inconsistent with the public interest.'' 21
U.S.C. 823(f). Accordingly, I will order that Applicant's application
be denied.
Order
Pursuant to the authority vested in me by 21 U.S.C. 823(f) and 28
CFR 0.100(b), I order that the application of Anthony E. Wicks, M.D.,
for a DEA Certificate of Registration as a practitioner be, and it
hereby is, denied. This Order is effective immediately.
Dated: September 30, 2013.
Thomas M. Harrigan,
Deputy Administrator.
[FR Doc. 2013-24694 Filed 10-21-13; 8:45 am]
BILLING CODE 4410-09-P