[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]
BILLING CODE 4160-01-F
