[Federal Register Volume 62, Number 166 (Wednesday, August 27, 1997)]
[Notices]
[Page 45423]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-22704]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 95N-0071]
Amirul Islam; Final Debarment Order
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) permanently
debarring Mr. Amirul Islam, 120 Adams St., Deer Park, NY 11729, from
providing services in any capacity to a person that has an approved or
pending drug product application. FDA bases this order on a finding
that Mr. Islam was convicted of a felony under Federal law for conduct
relating to the regulation of a drug product under the act. Mr. Islam
has waived his opportunity for a hearing concerning this action.
EFFECTIVE DATE: August 27, 1997.
ADDRESSES: Application for termination of debarment 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.
SUPPLEMENTARY INFORMATION:
I. Background
Mr. Amirul Islam, a former vice president of technical services for
Halsey Drug Co., Inc., (Halsey) and supervisor of Halsey's Quality
Control Laboratory, pled guilty to, and on October 19, 1994, was
sentenced for, obstructing an agency proceeding, a Federal felony under
18 U.S.C. 1505. The basis for this conviction was as follows: On or
about August 29, 1989, Mr. Islam gave FDA inspectors a raw material
inventory card for fenoprofen calcium which he knew to be false. The
inventory card stated that Halsey had received 50 kilograms of
fenoprofen calcium on September 11, 1987. In fact, Halsey had received
only half that amount. Mr. Islam knew that the purpose of the falsified
inventory card was to conceal from FDA the fact that Halsey did not
have enough raw material from the September 11, 1987, shipment to
manufacture pilot batches in the sizes represented in abbreviated new
drug applications (ANDA's) for fenoprofen calcium 200 milligram (mg)
capsules, fenoprofen calcium 300 mg capsules, and fenoprofen calcium
600 mg tablets.
Mr. Islam is subject to debarment based on a finding, under
section 306(a) of the act (21 U.S.C. 355a(a)), that he was convicted of
a felony under Federal law for conduct relating to the regulation of a
drug product. Mr. Islam's conduct related to the regulation of a drug
product because, in presenting false raw material inventory records, he
obstructed FDA's regulation of generic drugs by representing that the
ANDA's submitted by Halsey were true in all material respects.
FDA initiated debarment proceedings against Mr. Islam on or about
May 15, 1995. A person subject to debarment is entitled to an
opportunity for an agency hearing on disputed issues of material fact
under section 306(i) of the act, but Mr. Islam waived his opportunity
for a hearing and any contentions concerning his debarment by letter
received by FDA on April 22, 1997.
II. Findings and Order
Therefore, the Director, Center for Drug Evaluation and Research,
under section 306(a)(2)(B) of the act, and under authority delegated to
her (21 CFR 5.99), finds that Mr. Amirul Islam has been convicted of a
felony under Federal law for conduct relating to the regulation of a
drug product.
As a result of the foregoing findings and based on his
notification of acquiescence, Mr. Amirul Islam is permanently debarred
from providing services in any capacity to a person with an approved or
pending drug product application under sections 505, 507, 512, or 802
of the act (21 U.S.C. 355, 357, 360b, or 382), or under section 351 of
the Public Health Service Act (42 U.S.C. 262), effective August 27,
1997 (sections 306(c)(1)(B) and (c)(2)(A)(ii) and 201(dd) of the act
(21 U.S.C. 321(dd))). Any person with an approved or pending drug
product application who knowingly uses the services of Mr. Islam, in
any capacity, during his period of debarment, will be subject to civil
money penalties (section 307(a)(6) of the act (21 U.S.C. 335b(a)(6))).
If Mr. Islam, during his period of debarment, provides services in any
capacity to a person with an approved or pending drug product
application, he will be subject to civil money penalties (section
307(a)(7) of the act). In addition, FDA will not accept or review any
ANDA's or abbreviated antibiotic drug applications submitted by or with
the assistance of Mr. Islam during his period of debarment.
Any application by Mr. Islam for termination of debarment under
section 306(d) of the act should be identified with Docket No. 95N-0071
and sent to the Dockets Management Branch (address above). All such
submissions are to be filed in four copies. The public availability of
information in these submissions is governed by 21 CFR 10.20(j).
Publicly available submissions may be seen in the Dockets Management
Branch between 9 a.m. and 4 p.m., Monday through Friday.
Dated: August 19, 1997.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 97-22704 Filed 8-26-97; 8:45 am]
BILLING CODE 4160-01-F
