[Federal Register Volume 76, Number 46 (Wednesday, March 9, 2011)]
[Notices]
[Pages 12971-12972]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-5308]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0473]


David E. Berman: Debarment Order

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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[[Page 12972]]

SUMMARY: The Food and Drug Administration (FDA) is issuing an order 
under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring 
David E. Berman, MD, for 3 years from providing services in any 
capacity to a person that has an approved or pending drug product 
application. FDA bases this order on a finding that Dr. Berman 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. Berman was given notice of the proposed 
debarment and an opportunity to request a hearing within the timeframe 
prescribed by regulation. Dr. Berman failed to respond. Dr. Berman's 
failure to respond constitutes a waiver of his right to a hearing 
concerning this action.

DATES: This order is effective March 9, 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, 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 October 30, 2007, Dr. Berman pleaded guilty to a misdemeanor 
offense of the introduction into interstate commerce of a misbranded 
drug in violation of 21 U.S.C 331(a), 333(a)(1), and 352(i)(3), and 
judgment was entered against Dr. Berman by the U.S. District Court, 
Eastern District of Virginia.
    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. Berman is a medical doctor licensed by 
the Virginia Department of Health Professions, specializing in plastic 
surgery with an office in Sterling, VA. On or about January 16, 2004, 
and on or about February 16, 2004, Dr. Berman caused TRI-toxin, an 
unapproved botulinum toxin type A product, to be introduced into 
interstate commerce by causing Toxin Research International, Inc., to 
ship vials of TRI-toxin from Arizona to the Eastern District of 
Virginia. TRI-toxin was a misbranded drug in that Dr. Berman offered it 
for sale to, and used it on, thirty of his patients as BOTOX Cosmetic. 
Dr. Berman did not disclose to his patients that he was using a 
substitute, unapproved, unlicensed, and less expensive botulinum toxin 
type A product. TRI-toxin was not duly registered with the FDA and, 
therefore, the TRI-toxin is deemed misbranded.
    As a result of his convictions, on December 17, 2010, FDA sent Dr. 
Berman a notice by certified mail proposing to debar him for 3 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. 
Berman 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. 
Berman 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. Berman failed to respond within the timeframe prescribed by 
regulation and therefore has 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 David E. Berman 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. Berman is debarred for 3 
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. Berman, in any capacity during Dr. 
Berman'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. Berman 
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. Berman 
during his period of debarment (section 306(c)(1)(B) of the FD&C Act).
    Any application by Dr. Berman for termination of debarment under 
section 306(d)(4) of the FD&C Act should be identified with Docket No. 
FDA-2010-N-0473 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: February 16, 2011.
Howard R. Sklamberg,
Director, Office of Enforcement, Office of Regulatory Affairs.
[FR Doc. 2011-5308 Filed 3-8-11; 8:45 am]
BILLING CODE 4160-01-P