03-25594. Amirul Islam; Grant of Special Termination; Final Order Terminating Debarment

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

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 Amirul Islam. FDA bases this order on a finding that Mr. Islam provided substantial assistance in the investigations or prosecutions of offenses relating to a matter under FDA's jurisdiction and that special termination of Mr. Islam's debarment serves the interest of justice and does not threaten the integrity of the drug approval process.

DATES:

This order is effective October 9, 2003.

ADDRESSES:

Comments should reference Docket No. 1995N-0071 and be sent to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Nicole K. Mueller, 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 August 27, 1997 (62 FR 45423), Amirul Islam, the former vice president of technical services for Halsey Drug Co. Inc. (Halsey), and supervisor of Halsey's Quality Control Laboratory, 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) of the act (21 U.S.C. 335a(c)(1)(B) and (c)(2)(A)(ii) and section 201(dd) of the act (21 U.S.C. 321(dd))). The debarment was based on FDA's finding that Mr. Islam 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 December 12, 1997, Mr. Islam applied for special termination of debarment under section 306(d)(4)(a) of the act, as amended by the Generic Drug Enforcement Act (GDEA).

Under section 306(d)(4)(C) and (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 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. Mr. Islam cooperated with the Department of Justice investigations and prosecutions of others, as substantiated by the letters submitted to the agency by the Assistant U.S. Attorney who prosecuted Mr. Islam's case. Accordingly, FDA finds that Mr. Islam 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 Mr. Islam 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 Mr. Islam's debarment was based is unlikely to recur. For these reasons, the agency finds that termination of Mr. Islam's debarment serves the interest of justice and will not pose a threat to the integrity of the drug approval process. FDA's analysis in reaching this conclusion is contained in the docket.

Under section 306(d)(4)(D)(ii) 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. Mr. Islam's period of debarment has lasted more than 1 year. Accordingly, the Associate Commissioner for Regulatory Affairs, under section 306(d)(4) of the act and under authority delegated to him (21 CFR 5.20), finds that Amirul Islam'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 Associate Commissioner for Regulatory Affairs further finds that because Mr. Islam has waived his right to a hearing, and the agency is granting Mr. Islam's application, an informal hearing under section 306(d)(4)(C) of the act is unnecessary.

As a result of the foregoing findings, Amirul Islam's debarment is terminated effective October 9, 2003 (21 U.S.C. 335a(d)(4)(C) and (d)(4)(D)).

Dated: October 1, 2003.

John Marzilli,

Acting Associate Commissioner for Regulatory Affairs.