[Federal Register Volume 62, Number 63 (Wednesday, April 2, 1997)]
[Notices]
[Page 15713]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-8272]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 94N-0011]
Barry D. Garfinkel; Denial of Hearing; Final Debarment Order
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) denies Dr. Barry D.
Garfinkel's request for a hearing and issues a final order under the
Federal Food, Drug, and Cosmetic Act (the act) permanently debarring
Barry D. Garfinkel, 2854 Glenhurst Ave., St. Louis Park, MN 55416, from
providing services in any capacity to a person that has an approved or
pending drug product application. FDA bases this order on its finding
that Dr. Garfinkel was convicted of a felony under Federal law for
conduct relating to the development or approval of a drug product and
for conduct relating to the regulation of a drug product under the act.
EFFECTIVE DATE: April 2, 1997.
ADDRESSES: Application for termination of debarment to the Dockets
Management Branch (HFA-305), Food and Drug Administration, 12420
Parklawn Dr., rm. 1-23, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Mary E. Catchings, Center for Drug
Evaluation and Research (HFD-7), Food and Drug Administration, 1451
Rockville Pike, Rockville, MD 20857, 301-594-2041.
SUPPLEMENTARY INFORMATION:
I. Background
On November 19, 1993, the United States District Court for the
District of Minnesota entered judgment against Barry D. Garfinkel for,
among other counts, 3 counts of making a false statement in a matter
within the jurisdiction of FDA, a Federal felony offense under 18
U.S.C. 1001. The basis for this conviction was Dr. Garfinkel's
falsification of reports to conceal his failure to comply with the
protocols of a clinical study of the drug Anafranil. Dr. Garfinkel's
conviction was affirmed by the Eighth Circuit Court of Appeals on July
13, 1994.
As a result of this conviction, FDA served Dr. Garfinkel by
certified mail on February 7, 1995, a letter proposing to issue an
order under section 306(a) of the act (21 U.S.C. 335a(a)) permanently
debarring him from providing services in any capacity to a person that
has an approved or pending drug product application and offering him an
opportunity for a hearing on the proposal. The proposal was based on a
finding, under section 306(a)(2)(A) and (a)(2)(B) of the act, that Dr.
Garfinkel was convicted of a felony under Federal law for conduct
relating to the development, approval, and regulation of a drug
product. Dr. Garfinkel requested a hearing in a letter dated February
16, 1995. However, Dr. Garfinkel has not submitted any information or
analyses to justify a hearing. Dr. Garfinkel's failure to raise any
issues of fact constitutes a waiver of his opportunity for a hearing
and a waiver of any contentions concerning his debarment (21 CFR
12.22).
II. Findings and Order
Therefore, the Deputy Commissioner for Operations, under section
306(a) of the act and under authority delegated to him (21 CFR 5.20),
finds that Barry D. Garfinkel has been convicted of a felony under
Federal law for conduct relating to the development or approval of a
drug product and for conduct relating to regulation of a drug product
(21 U.S.C. 335a(a)(2)(B)).
As a result of the foregoing finding, Barry D. Garfinkel is
permanently debarred from providing services in any capacity to a
person with an approved or pending drug product application under
sections 505, 507, 512, or 802 of the act (21 U.S.C. 355, 357, 360b, or
382), or under section 351 of the Public Health Service Act (42 U.S.C.
262), effective April 2, 1997 sections 306(c)(1)(B) and (c)(2)(A)(ii)
and 201(dd) of the act (21 U.S.C. 321(dd)). Any person with an approved
or pending drug product application who knowingly uses the services of
Dr. Garfinkel, in any capacity, during his period of debarment, will be
subject to a civil money penalty (section 307(a)(6) of the act (21
U.S.C. 335b(a)(6))). If Dr. Garfinkel, during his period of debarment,
provides services in any capacity to a person with an approved or
pending drug product application, he will be subject to a civil money
penalty (section 307(a)(7) of the act). In addition, FDA will not
accept or review any abbreviated new drug applications or abbreviated
antibiotic drug applications submitted by or with the assistance of Dr.
Garfinkel during his period of debarment.
Dr. Garfinkel may file an application to attempt to terminate his
debarment under section 306(d)(4)(A) of the act. Any such application
would be reviewed under the criteria and processes set forth in section
306(d)(4)(C) and (d)(4)(D) of the act. Such an application should be
identified with Docket No. 94N-0011 and sent to the Dockets Management
Branch (address above). 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 Dockets Management Branch between 9 a.m. and 4 p.m., Monday
through Friday.
Dated: March 24, 1997.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 97-8272 Filed 4-1-97; 8:45 am]
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