Inspections, Compliance, Enforcement, and Criminal Investigations
[Federal Register: September 11, 1998 (Volume 63, Number 176)]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 93N-0253]
Mark Perkal; Grant of Special Termination; Final Order
AGENCY: Food and Drug Administration, HHS.
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.
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
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
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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