David E. Berman: Debarment Order, 12971-12972 [2011-5308]
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Federal Register / Vol. 76, No. 46 / Wednesday, March 9, 2011 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0441]
Anastasios Pappas: Debarment Order
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is issuing an
order under the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) debarring
Anastasios Pappas, MD, 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. Pappas
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. Pappas was given notice of the
proposed debarment and an opportunity
to request a hearing within the
timeframe prescribed by regulation. Dr.
Pappas failed to respond. Dr. Pappas’
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:
SUMMARY:
Emcdonald on DSK2BSOYB1PROD with NOTICES
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 4, 2006, Dr. Pappas pleaded
guilty to a misdemeanor offense of
introducing and causing the
introduction into interstate commerce of
a misbranded drug in violation of 21
U.S.C. 352(o), 331(a) and 333(a)(1). On
VerDate Mar<15>2010
18:04 Mar 08, 2011
Jkt 223001
August 14, 2006, the U.S. district court
for the district of South Dakota,
Southern Division, entered judgment
against Dr. Pappas for misdemeanor
misbranding.
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. Pappas was
a licensed dermatologist in the state of
South Dakota and a partner with Dakota
Dermatology in Sioux Falls, SD.
Between August and November 2004, in
the District of South Dakota and
elsewhere, Dr. Pappas placed three
orders for a total of six vials of
botulinum toxin type A (TRI-toxin) from
Toxin Research International (TRI).
Between September and November
2004, Dr. Pappas administered TRItoxin to patients. TRI was not duly
registered with FDA and, therefore, the
TRI-toxin is deemed misbranded under
21 U.S.C. 352(o).
As a result of his convictions, on
November 16, 2010, FDA sent Dr.
Pappas 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. Pappas 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. Pappas 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. Pappas 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 Anastasios Pappas
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.
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
12971
As a result of the foregoing finding,
Dr. Pappas 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. 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. Pappas, in any capacity
during Dr. Pappas’ 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. Pappas 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 (21 U.S.C. 335b(a)(7))). In
addition, FDA will not accept or review
any abbreviated new drug applications
submitted by or with the assistance of
Dr. Pappas during his period of
debarment (section 306(c)(1)(B) of the
FD&C Act).
Any application by Dr. Pappas 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–2010–N–0441 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 Sklamberg,
Director, Office of Enforcement, Office of
Regulatory Affairs.
[FR Doc. 2011–5309 Filed 3–8–11; 8:45 am]
BILLING CODE 4160–01–P
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:
E:\FR\FM\09MRN1.SGM
Notice.
09MRN1
12972
Federal Register / Vol. 76, No. 46 / Wednesday, March 9, 2011 / Notices
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:
Emcdonald on DSK2BSOYB1PROD with NOTICES
SUMMARY:
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
VerDate Mar<15>2010
18:04 Mar 08, 2011
Jkt 223001
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
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0002]
Joint Meeting of the Nonprescription
Drugs Advisory Committee and the
Pediatric Advisory Committee; Notice
of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
E:\FR\FM\09MRN1.SGM
09MRN1
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
[[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
