Inspections, Compliance, Enforcement, and Criminal Investigations
[Federal Register: February 28, 1996 (Volume 61, Number 40)]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
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.
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.
-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
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.
- 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