[Federal Register Volume 76, Number 103 (Friday, May 27, 2011)]
[Notices]
[Page 30946]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-13196]



[[Page 30946]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0471]


Adrien E. Aiache: Debarment Order

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) (the Agency) is issuing 
an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) 
debarring Adrien Aiache, M.D. for 5 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. Aiache 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. Aiache was given notice of the proposed 
debarment and an opportunity to request a hearing within the timeframe 
prescribed by regulation. Dr. Aiache failed to respond. Dr. Aiache's 
failure to respond constitutes a waiver of his right to a hearing 
concerning this action.

DATES: This order is effective May 27, 2011.

ADDRESSES: Submit applications for termination of debarment to the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, Room 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Kenny Shade, Office of Regulatory 
Affairs (HFC-230), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-796-4640.

SUPPLEMENTARY INFORMATION: 

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 June 26, 2007, Dr. Aiache pleaded guilty to a misdemeanor 
offense of receipt in interstate commerce of a misbranded drug and 
delivery thereof in violation of 21 U.S.C. 331(c), 333(a)(1), and 
352(f), and the United States District Court for the Central District 
of California entered judgment against him.
    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. Aiache was a licensed physician with an 
office in Beverly Hills, California. In 2003, Dr. Aiache began ordering 
an unapproved Botulinum Toxin Type A drug, Tri-toxin, manufactured by 
Toxin Research International, Inc. (TRI), instead of the approved 
BOTOX/BOTOX Cosmetic. From on or about September 3, 2003, and 
continuing to on or about October 25, 2004, Dr. Aiache placed sixteen 
orders for a total of thirty-four vials of TRI-toxin which he had 
shipped from Tucson, Arizona to California. He then administered the 
TRI-toxin to others for the treatment of facial wrinkles. 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 invoices. Dr. Aiache 
admitted in an interview on May 13, 2005, that he had injected the TRI-
toxin into family members, medical staff personnel, personal friends, 
and himself.
    As a result of his convictions, on February 2, 2011, FDA sent Dr. 
Aiache a notice by certified mail proposing to debar him for 5 years 
from providing services in any capacity to a person that has an 
approved or pending drug product application. The proposal was based on 
a finding, under section 306(b)(2)(B)(i)(I) of the FD&C Act, that Dr. 
Aiache was convicted of a misdemeanor under Federal law for conduct 
relating to the regulation of drug products under the FD&C Act, and the 
conduct that served as a basis for the conviction undermines the 
process for the regulation of drugs. The proposal also offered Dr. 
Aiache 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. Aiache 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 Adrien E. Aiache 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. Aiache is debarred for 5 
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. 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. Aiache, 
in any capacity during Dr. Aiache'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. Aiache 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. Aiache during his period of debarment (section 
306(c)(1)(B) of the FD&C Act (21 U.S.C. 335a(c)(1)(B)).
    Any application by Dr. Aiache for termination of debarment under 
section 306(d)(1) of the FD&C Act should be identified with Docket No. 
FDA-2010-N-0471 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: May 16, 2011.
Howard Sklamberg,
Director, Office of Enforcement, Office of Regulatory Affairs.
[FR Doc. 2011-13196 Filed 5-26-11; 8:45 am]
BILLING CODE 4160-01-P