Inspections, Compliance, Enforcement, and Criminal Investigations
[Federal Register: March 11, 1997 (Volume 62, Number 47)]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 93N-0252]
Atul Shah; Grant of Special Termination; Final Order Terminating Debarment
AGENCY: Food and Drug Administration, HHS.
SUMMARY: The Food and Drug Administration (FDA) is issuing a final order under the Federal Food, Drug, and Cosmetic Act (the act) granting special termination of the debarment of Dr. Atul Shah, 20 Hampton Hollow Dr., Perrineville, NJ 08535. FDA bases this order on a finding that Dr. Shah has
provided substantial assistance in the investigations or prosecutions of offenses relating to a matter under FDA's jurisdiction, and that special termination of Dr. Shah's debarment serves the interest of justice and does not threaten the integrity of the drug approval process.
EFFECTIVE DATE: March 11, 1997.
ADDRESSES: Submit written comments to the Dockets Management Branch (HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. Comments should be identified with the docket number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Diane Sullivan-Ford, Center for Drug Evaluation and Research (HFD-7), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-594-2041.
SUPPLEMENTARY INFORMATION: In a Federal Register notice dated December 5, 1994 (59 FR 62399), Dr. Atul Shah, the former Director of Analytical Research and Development at Par Pharmaceutical, Inc. (Par), 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. Shah 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 March 30, 1995, Dr. Shah 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.
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 section 306(a) or (b) 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 Dr. Shah's 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. At Dr. Shah's sentencing, the Assistant U.S. Attorney prosecuting Dr. Shah, recommended a reduced sentence based on Dr. Shah's ``substantial assistance'' to the Government in its investigation. Accordingly, FDA finds that Dr. Shah provided substantial assistance as required by section 306(d)(4)(C) of the act.
The additional requisite showings, i.e., 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.
Based on a thorough analysis of the available evidence, Dr. Atul Shah has demonstrated that termination of his 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. Shah's period of debarment, which commenced on December 5, 1994, 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 Dr. Atul Shah'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. Shah's application, an informal hearing under section 306(d)(4)(C) of the act is unnecessary.
As a result of the foregoing findings, Dr. Atul Shah's debarment is terminated, effective (insert date of publication in the Federal Register) (21 U.S.C. 335a(d)(4)(C) and (d)(4)(D)).
Dated: February 27, 1997.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 97-6066 Filed 3-10-97; 8:45 am]
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