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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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04/02/1997

[Federal Register: April 2, 1997 (Volume 62, Number 63)]

[Notices]

[Page 15713]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr02ap97_dat-88]

 

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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]

BILLING CODE 4160-01-F