08/27/1997

[Federal Register: August 27, 1997 (Volume 62, Number 166)]

[Notices]              

[Page 45423]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr27au97-89]

 

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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