[Federal Register Volume 61, Number 40 (Wednesday, February 28, 1996)]
[Notices]
[Pages 7521-7522]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-4473]



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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]
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