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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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02/28/1996

[Federal Register: February 28, 1996 (Volume 61, Number 40)]

[Notices]              

[Page 7521-7522]

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

[DOCID:fr28fe96-91]

 

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

 

Food and Drug Administration

[Docket No. 95N-0280]

 

Fredrick Jay Shainfeld; 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 Dr. Fredrick Shainfeld 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 Dr. Shainfeld was

convicted of a felony under Federal law for conduct relating to the

development or approval, including the process for development or

approval, of a drug product; and relating to the regulation of a drug

product under the act. Dr. Shainfeld has notified FDA that he

acquiesces to debarment and, therefore, has waived his opportunity for

a hearing concerning this action.

 

EFFECTIVE DATE: March 10, 1995.

 

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:  Tamar S. Nordenberg, Center for Drug

Evaluation and Research (HFD-7), Food and Drug Administration, 7500

Standish Pl., Rockville, MD 20855, 301-594-2041.

 

SUPPLEMENTARY INFORMATION:

 

-I. Background-

    

-Dr. Fredrick Shainfeld, a former senior vice president of

Technical and Regulatory Affairs and New Product Development at Halsey

Drug Co. (Halsey), was sentenced on January 6, 1995, pursuant to a

guilty plea, for obstruction of an agency proceeding, a Federal felony

under 18 U.S.C. 1505. The basis for this conviction was as follows:

 

-Dr. Shainfeld, in his capacity as senior vice president for

Technical and Regulatory Affairs and New Product Development,

supervised Halsey's regulatory filings to FDA. During a 1989 FDA

establishment inspection of Halsey, Dr. Shainfeld and other members of

Halsey's upper management provided FDA inspectors with a falsified raw

material inventory card for Fenoprofen Calcium.

 

-Dr. Shainfeld knew that the raw material card falsely stated that

Halsey had received 50 kilograms of Fenoprofen Calcium on September 11,

1987, when in fact Halsey had received half that amount, and Dr.

Shainfeld knew that the purpose of the falsification was to conceal

from FDA that Halsey did not have enough raw material to manufacture

its pilot batches in the sizes represented in abbreviated new drug

applications (ANDA's) for the generic drug product Fenoprofen Calcium.

 

-Dr. Shainfeld is subject to debarment based on a finding, under

section 306(a)(2) of the act (21 U.S.C. 335a(a)(2)), that he was

convicted of a felony under Federal law for conduct relating to the

development, approval, and regulation of a drug product.

 

-The purpose of the falsification of the raw material inventory

cards for Fenoprofen Calcium was to conceal from FDA the fact that

Halsey did not have enough raw material to manufacture its pilot

batches in the sizes represented in the product's ANDA's. The

falsification relates to the development or approval of a drug product

because FDA makes its decisions whether to approve a product based on

the information in the ANDA's. If the pilot batches were not

manufactured in the sizes represented in the ANDA's, FDA made its

approval decisions based on erroneous information.

 

-The falsification of the raw material inventory cards relates to

the regulation of drug products because FDA's regulatory decisions

about Halsey drug

 

[[Page 7522]]

products may have been affected by the conduct.

 

-In a letter received by FDA on March 10, 1995, Dr. Shainfeld

notified FDA of his acquiescence to debarment, as provided for in

section 306(c)(2)(B) of the act. 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 by acquiescing to

debarment, Dr. Shainfeld waived his opportunity for a hearing and any

contentions concerning his debarment.

 

-II. Findings and Order

    

-Therefore, the Deputy Commissioner for Operations, under section

306(a) of the act, and under authority delegated to him (21 CFR 5.20),

finds that Dr. Fredrick Shainfeld has been convicted of a felony under

Federal law for conduct: (1) Relating to the development or approval,

including the process for development or approval, of a drug product

(21 U.S.C. 335a(a)(2)(A)); and (2) relating to the regulation of a drug

product (21 U.S.C. 335a(a)(2)(B)).

 

- As a result of the foregoing findings and based on his

notification of acquiescence, Dr. Fredrick Shainfeld is permanently

debarred from providing services in any capacity to a person with an

approved or pending drug product application under section 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

March 10, 1995, the date of notification of acquiescence (21 U.S.C.

335a(c)(1)(B) and (c)(2)(A)(ii) and 21 U.S.C. 321(dd)). Any person with

an approved or pending drug product application who knowingly uses the

services of Dr. Shainfeld, in any capacity, during his period of

debarment, will be subject to civil money penalties. If Dr. Shainfeld,

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. In addition, FDA will not accept or

review any abbreviated new drug applications submitted by or with the

assistance of Dr. Shainfeld during his period of debarment.

 

-Any application by Dr. Shainfeld for termination of debarment

under section 306(d)(4) of the act should be identified with Docket No.

95N-0280 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: February 8, 1996.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 96-4473 Filed 2-27-96; 8:45 am]

BILLING CODE 4160-01-F