[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]
BILLING CODE 4160-01-P