[Federal Register Volume 76, Number 152 (Monday, August 8, 2011)]
[Notices]
[Pages 48168-48169]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-19976]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0126]
Andrew K. Choi: Debarment Order
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is issuing an order
under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring
Andrew K. Choi, M.D. for 4 years from providing services in any
capacity to a person that has an approved or pending drug product
application. FDA bases this order on findings that Dr. Choi was
convicted of a misdemeanor under Federal law for conduct relating to
the regulation of a drug product under the FD&C Act and that the type
of conduct underlying the conviction undermines the process for the
regulation of drugs. Dr. Choi was given notice of the proposed
debarment and an opportunity to request a hearing within the timeframe
prescribed by regulation. Dr. Choi failed to respond. Dr. Choi's
failure to respond constitutes a waiver of his right to a hearing
concerning this action.
DATES: This order is effective August 8, 2011.
ADDRESSES: Submit applications for termination of debarment to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Kenny Shade, Division of Compliance
Policy (HFC-230), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-796-4640.
SUPPLEMENTARY INFORMATION:
[[Page 48169]]
I. Background
Section 306(b)(2)(B)(i)(I) of the FD&C Act (21 U.S.C.
335a(b)(2)(B)(i)(I)) permits FDA to debar an individual if it finds
that the individual has been convicted of a misdemeanor under Federal
law for conduct relating to the regulation of drug products under the
FD&C Act, and if FDA finds that the type of conduct that served as the
basis for the conviction undermines the process for the regulation of
drugs.
On April 2, 2007, Dr. Choi pleaded guilty to one count of receipt
in interstate commerce of a misbranded drug and delivery thereof in
violation of sections 301(c), 303(c), and 502(f) of the FD&C Act (21
U.S.C. 331(c), 333(a)(1), and 352(f)). On August 11, 2008, the U.S.
District Court for the Central District of California entered judgment
against Dr. Choi for the misdemeanor offense of receipt in interstate
commerce of a misbranded drug and delivery thereof.
FDA's finding that debarment is appropriate is based on the
misdemeanor conviction referenced herein. The factual basis for the
conviction is as follows: Dr. Choi was a licensed physician in the
State of California. Prior to November 13, 2003, Dr. Choi injected
patients with Botox[supreg], an FDA-approved Botulinum Toxin Type A
drug product manufactured by Allergan, Inc. In 2003, Dr. Choi began
ordering an unapproved drug purported to be Botulinum Toxin Type A
(TRI-Toxin) manufactured by Toxin Research International, Inc. (TRI),
located in Tucson, Arizona, instead of the approved Botox[supreg]. From
on or about November 13, 2003, and continuing until about August 3,
2004, Dr. Choi placed 14 orders for a total of 28 vials of TRI-Toxin,
which he had shipped to his office in the Central District of
California. The TRI-Toxin did not come with labeling or directions on
how to dilute the product for injection. The TRI-Toxin label stated
``for research purposes only'' and ``not for human use,'' as did the
TRI-Toxin invoices. Dr. Choi admitted to injecting the TRI-Toxin into
his employees and patients. Between on or about November 13, 2003, and
continuing until on or about August 3, 2004, Dr. Choi received and
delivered the TRI-Toxin when he administered it to other persons, all
in violation of sections 301(c), 303(c), and 502(f) of the FD&C Act.
As a result of his conviction, on April 22, 2011, FDA sent Dr. Choi
a notice by certified mail proposing to debar him for 4 years from
providing services in any capacity to a person that has an approved or
pending drug product application. FDA subsequently confirmed on May 9,
2011, that Dr. Choi personally received the notice. The proposal was
based on a finding, under section 306(b)(2)(B)(i)(I) of the FD&C Act
that Dr. Choi was convicted of a misdemeanor under Federal law for
conduct relating to the regulation of drug products under the FD&C Act,
and that the conduct that served as a basis for the conviction
undermines the process for the regulation of drugs. The proposal also
offered Dr. Choi an opportunity to request a hearing, providing him 30
days from the date of receipt of the letter in which to file the
request, and advised him that failure to request a hearing constituted
a waiver of the opportunity for a hearing and of any contentions
concerning this action. Dr. Choi failed to respond within the timeframe
prescribed by regulation and has therefore, waived his opportunity for
a hearing and waived any contentions concerning his debarment (21 CFR
part 12).
II. Findings and Order
Therefore, the Director, Office of Enforcement, Office of
Regulatory Affairs, under section 306(b)(2)(B)(i)(I) of the FD&C Act
under authority delegated to him (Staff Manual Guide 1410.35), finds
that Andrew K. Choi has been convicted of a misdemeanor under Federal
law for conduct relating to the regulation of a drug product under the
FD&C Act, and that the type of conduct that served as a basis for the
conviction undermines the process for the regulation of drugs.
As a result of the foregoing finding, Dr. Choi is debarred for 4
years from providing services in any capacity to a person with an
approved or pending drug product application under sections 505, 512,
or 802 of the FD&C Act (21 U.S.C. 355, 360b, or 382), or under section
351 of the Public Health Service Act (42 U.S.C. 262), effective (see
DATES), (see sections 306(c)(1)(B), (c)(2)(A)(iii), and 201(dd) of the
FD&C Act (21 U.S.C. 335a(c)(1)(B), (c)(2)(A)(iii), and 321(dd))). Any
person with an approved or pending drug product application who
knowingly employs or retains as a consultant or contractor, or
otherwise uses the services of Dr. Choi, in any capacity during Dr.
Choi's debarment, will be subject to civil money penalties (section
307(a)(6) of the FD&C Act (21 U.S.C. 335b(a)(6))). If Dr. Choi provides
services in any capacity to a person with an approved or pending drug
product application during his period of debarment he will be subject
to civil money penalties (section 307(a)(7) of the FD&C Act). In
addition, FDA will not accept or review any abbreviated new drug
applications submitted by or with the assistance of Dr. Choi during his
period of debarment (section 306(c)(1)(B) of the FD&C Act).
Any application by Dr. Choi for termination of debarment under
section 306(d)(1) of the FD&C Act (21 U.S.C. 335a(d)(1)) should be
identified with Docket No. FDA-2011-N-0126 and sent to the Division of
Dockets Management (see ADDRESSES). All such submissions are to be
filed in four copies. The public availability of information in these
submissions is governed by 21 CFR 10.20(j).
Publicly available submissions may be seen in the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
Dated: July 27, 2011.
Armando Zamora,
Acting Director, Office of Enforcement, Office of Regulatory Affairs.
[FR Doc. 2011-19976 Filed 8-5-11; 8:45 am]
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