09/11/1998

[Federal Register: September 11, 1998 (Volume 63, Number 176)]

[Notices]              

[Page 48733-48734]

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

[DOCID:fr11se98-86]

 

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

 

Food and Drug Administration

[Docket No. 93N-0253]

 

 

Mark Perkal; Grant of Special Termination; Final Order

Terminating Debarment

 

AGENCY: Food and Drug Administration, HHS.

 

ACTION:  Notice.

 

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SUMMARY:  The Food and Drug Administration (FDA) is issuing an order

under the Federal Food, Drug, and Cosmetic Act (the act) granting

special termination of the debarment of Mark Perkal, Israel. FDA bases

this order on a finding that Dr. Perkal provided substantial assistance

in the investigations or prosecutions of offenses relating to a matter

under FDA's jurisdiction and that special termination of Dr. Perkal's

debarment serves the interest of justice and does not threaten the

integrity of the drug approval process.

 

EFFECTIVE DATE: September 11, 1998.

ADDRESSES:  Comments should reference Docket No. 93N-0253 and be sent

to the Dockets Management Branch (HFA-305), Food and Drug

Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

 

FOR FURTHER INFORMATION CONTACT:  Leanne Cusumano, Center for Drug

Evaluation and Research (HFD-7), Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857, 301-594-2041.

 

SUPPLEMENTARY INFORMATION:

 

In a Federal Register notice dated November 29, 1993 (58 FR 62676),

Mark Perkal, the former Executive Vice President and Chief Scientific

Officer of PharmaKinetics Laboratories, Inc., was permanently debarred

from providing services in any capacity to a person with an approved or

pending drug product application (21 U.S.C. 335a(c)(1)(B) and

(c)(2)(A)(ii) and 21 U.S.C. 321(dd)). The debarment was based on FDA's

finding that Dr. Perkal was convicted of a felony under Federal law for

conduct relating to the development or approval of any drug product, or

otherwise relating to the regulation of a drug product (21 U.S.C.

335a(a)(2)). On April 14, 1995, Dr. Perkal applied for special

termination of debarment under section 306(d)(4) of the act (21 U.S.C.

335a(d)(4)), as amended by the Generic Drug Enforcement Act (GDEA).

 

Under section 306(d)(4)(C) and (d)(4)(D) of the act, FDA may limit

the period of debarment of a permanently

 

[[Page 48734]]

 

debarred individual if the agency finds that: (1) The debarred

individual has provided substantial assistance in the investigation or

prosecution of offenses described in subsections (a) or (b) of section

306 of the act or relating to a matter under FDA's jurisdiction; (2)

termination of the debarment serves the interest of justice; and (3)

termination of the debarment does not threaten the integrity of the

drug approval process. Special termination of debarment is

discretionary with FDA.

 

FDA considers a determination by the Department of Justice

concerning the substantial assistance of a debarred individual

conclusive in most cases. Dr. Perkal cooperated with the Department of

Justice investigations and prosecutions of others, as substantiated by

the testimony of the Assistant U.S. Attorney at Dr. Perkal's

sentencing. Accordingly, FDA finds that Dr. Perkal provided substantial

assistance as required by section 306(d)(4)(C) of the act.

 

The additional requisite showings that termination of debarment

serves the interest of justice and poses no threat to the integrity of

the drug approval process are difficult standards to satisfy. In

determining whether these have been met, the agency weighs the

significance of all favorable and unfavorable factors in light of the

remedial, public health-related purposes underlying debarment.

Termination of debarment will not be granted unless, weighing all

favorable and unfavorable information, there is a high level of

assurance that the conduct that formed the basis for the debarment has

not recurred and will not recur, and that the individual will not

otherwise pose a threat to the integrity of the drug approval process.

 

The evidence presented to FDA in support of termination shows that

Dr. Perkal was convicted for a first offense; that he has no prior or

subsequent convictions for conduct described under the GDEA and has

committed no other wrongful acts affecting the drug approval process;

and that his character and scientific ability are highly regarded by

his professional peers. The evidence presented supports the conclusion

that the conduct upon which Dr. Perkal's debarment was based is

unlikely to recur. For these reasons, the agency finds that termination

of Dr. Perkal's debarment serves the interest of justice and will not

pose a threat to the integrity of the drug approval process.

 

Under section 306(d)(4)(D) of the act, the period of debarment of

an individual who qualifies for special termination may be limited to

less than permanent but to no less than 1 year. Dr. Perkal's period of

debarment has lasted more than 1 year. Accordingly, the Deputy

Commissioner for Operations, under section 306(d)(4) of the act and

under authority delegated to him (21 CFR 5.20), finds that Mark

Perkal's application for special termination of debarment should be

granted, and that the period of debarment should terminate immediately,

thereby allowing him to provide services in any capacity to a person

with an approved or pending drug product application. The Deputy

Commissioner for Operations further finds that because the agency is

granting Dr. Perkal's application, an informal hearing under section

306(d)(4)(C) of the act is unnecessary.

 

As a result of the foregoing findings, Dr. Mark Perkal's debarment

is terminated effective September 11, 1998 (21 U.S.C. 335a(d)(4)(C) and

(d)(4)(D)).

    

Dated: September 2, 1998.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 98-24375 Filed 9-10-98; 8:45 am]

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