[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]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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]
BILLING CODE 4160-01-F