Inspections, Compliance, Enforcement, and Criminal Investigations

06/10/1998

[Federal Register: June 10, 1998 (Volume 63, Number 111)]

[Notices]
[Page 31789-31790]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10jn98-104]


DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98N-0131]

Scott Feuer; Final Debarment Order
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.


SUMMARY: The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the act) debarring Scott Feuer, 25 Glenwood Rd., Tenafly, NJ 07670, for a period of 5 years from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on finding that Mr. Feuer was convicted of conspiracy to commit an offense against the United States and that Mr. Feuer's conduct undermined the process for the regulation of drugs. Mr. Feuer has failed to request a hearing and, therefore, has waived his opportunity for a hearing concerning this action.

EFFECTIVE DATE: June 2, 1998.

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:

  1. Background

    On March 24, 1993, the United States District Court for the District of Maryland accepted Mr. Feuer's plea of guilty to one count of conspiracy to commit an offense against the United States under 18 U.S.C. 371 and 18 U.S.C. 2. This conspiracy conviction was based on Mr. Feuer's directing others to change manufacturing procedures for the generic drug Fenoprophen, falsifying records in order to conceal from the FDA the manufacturing changes, and distributing the Fenoprophen without FDA approval of the formula actually distributed.

    As a result of this conviction, FDA served Mr. Feuer by certified mail on March 2, 1998, a notice proposing to debar him for a period of 5 years from providing services in any capacity to a person that has an approved or pending drug product application, and offered him an opportunity for a hearing on the proposal. The proposal was based on a finding, under section 306(a)(2)(B) of the act (21 U.S.C. 335a(a)(2)(B)), that Mr. Feuer was convicted of a conspiracy to commit a felony under Federal law for conduct relating to the regulation of a drug product and that Mr. Feuer's conduct undermined the process for the regulation of drugs. Mr. Feuer did not request a hearing. His failure to request a hearing constitutes a waiver of his opportunity for a hearing and a waiver of any contentions concerning his debarment.

  2. Findings and Order

    Therefore, the Director of the Center for Drug Evaluation and Research, under section 306(b) of the act, and under authority delegated to her (21 CFR 5.99(b)), finds that Scott Feuer has been convicted of conspiracy to commit a felony under Federal law for conduct relating to the regulation of a drug product and that Mr. Feur's conduct undermined the process for the regulation of drugs.

    As a result of the foregoing finding, Scott Feuer is 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 June 2, 1998 (sections 306(c)(1)(B) and (c)(2)(A)(ii) and 201(dd) of the act (21 U.S.C. 321(dd))), for a

    [[Page 31790]]

    period of 5 years. Any person with an approved or pending drug product application who knowingly uses the services of Mr. Feuer in any 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. Feuer, 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 abbreviated new drug applications or abbreviated antibiotic drug applications submitted by or with the assistance of Mr. Feuer during his period of debarment.

    Any application by Mr. Feuer for termination of debarment under section 306(d)(4) of the act should be identified with Docket No. 98N- 0131 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: May 18, 1998.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 98-15482 Filed 6-9-98; 8:45 am]

BILLING CODE 4160-01-F

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