Inspections, Compliance, Enforcement, and Criminal Investigations
[Federal Register: June 11, 1998 (Volume 63, Number 112)]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 96N-0003]
Dulal C. Chatterji; 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 Dr. Dulal C. Chatterji, 308 Dalton Dr., Raleigh, NC 27615. FDA bases this order on a finding that Dr. Chatterji provided substantial assistance in the investigations or prosecutions of offenses relating to a matter under FDA's jurisdiction, and that special termination of Dr. Chatterji's debarment serves the interest of justice and does not threaten the integrity of the drug approval process.EFFECTIVE DATE: June 11, 1998.
ADDRESSES: Comments should reference Docket No. 96N-0003 and be sent to the Dockets Management Branch (HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857.
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 January 22, 1997 (62 FR 3297), Dr. Dulal C. Chatterji, cofounder, part owner, vice-president for scientific affairs, and head of the research and development (R&D) division at the generic drug manufacturer Quad Pharmaceuticals, Inc. (Quad), was permanently debarred from providing services in any capacity to a person with an approved or pending drug product application under sections 306(c)(1)(B) and (c)(2)(A)(ii)) and 201(dd) of the act (21 U.S.C. 335a(c)(1)(B) and (c)(2)(A)(ii) and 321(dd)). The effective date of the debarment was November 1, 1995, based on Dr. Chatterji's acquiescence to debarment. The debarment was based on FDA's finding that Dr. Chatterji 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 under section 306 of the act. On April 7, 1997, Dr. Chatterji applied for special termination of debarment under section 306(d)(4) of the act, 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 the debarred individual has provided substantial assistance in the investigation or prosecution of offenses described in paragraph (a) or (b) of section 306 of the act or relating to a matter under FDA's jurisdiction. If substantial assistance is found, the extent to which debarment may be terminated will depend upon the agency's assessment of whether termination will serve the interest of justice and 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 that an individual provided substantial assistance conclusive in most cases. Dr. Chatterji fully cooperated with the Department of Justice investigations and prosecutions of others within Quad for offenses related to matters under FDA jurisdiction, as substantiated by two letters received by FDA from the U.S. Attorney's Office for the District of Maryland. Accordingly, FDA finds that Dr. Chatterji provided substantial assistance as described under section 306(d)(4)(C) of the act.
In determining whether termination of debarment serves the interest of justice and poses no threat to the integrity of the drug approval process, 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, despite the seriousness of the offense for which Dr. Chatterji was debarred, his conduct may have been an aberration, his character and scientific ability remain highly regarded by his professional peers, and that he may serve as a strong advocate for compliance with current good manufacturing practice regulations. For these reasons, the agency finds that termination of Dr. Chatterji'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. Chatterji'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 Dr. Dulal C. Chatterji'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. Chatterji's application, an informal hearing under section 306(d)(4)(C) of the act is unnecessary.
As a result of the foregoing findings, Dr. Dulal C. Chatterji's debarment is terminated effective June 11, 1998 (section 306(d)(4)(C) and (d)(4)(D) of the act).
Dated: June 5, 1998.
Michael A. Friedman,
Acting Commissioner of Food and Drugs.
[FR Doc. 98-15555 Filed 6-10-98; 8:45 am]
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