[Federal Register Volume 76, Number 46 (Wednesday, March 9, 2011)]
[Notices]
[Pages 12971-12972]
From the Federal Register Online via the Government Publishing 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]
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