[Federal Register Volume 62, Number 216 (Friday, November 7, 1997)]
[Notices]
[Pages 60249-60250]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-29399]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 93N-0451]


James Michael Anthony; Final 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 James Michael Anthony, M.D., 130 North McLean, Memphis, TN 
38104, 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. Anthony was convicted of a felony under Federal law 
for

[[Page 60250]]

conduct relating to the regulation of a drug product under the act. Dr. 
Anthony has failed to request a hearing and, therefore, has waived his 
opportunity for a hearing concerning this action.

EFFECTIVE DATE: November 7, 1997.

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:

I. Background

    On July 26, 1993, the U.S. District Court for the Western District 
of Tennessee accepted Dr. Anthony's plea of guilty and entered judgment 
against him for, among other counts, one count of trading prescription 
drug samples, a Federal felony offense under section 503(c)(1) of the 
act (21 U.S.C. 353(c)(1)). This felony conviction was based on the 
unlawful trade of a drug sample of Ansaid Tablets, which was not 
intended to be sold but rather was intended to promote the sale of the 
drug, in exchange for the drug Rocephin.
    As a result of this conviction, FDA served Dr. Anthony by certified 
mail on October 12, 1994, a notice proposing to permanently debar him 
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 Dr. Anthony was convicted of a felony under 
Federal law for conduct relating to the regulation of a drug product. 
Dr. Anthony was given 30 days to file objections and request a hearing. 
Dr. Anthony did not file objections or 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.

II. Findings and Order

    Therefore, the Director of the Center for Drug Evaluation and 
Research, under section 306(a) of the act, and under authority 
delegated to her (21 CFR 5.99(b)), finds that Dr. James Michael Anthony 
has been convicted of a felony under Federal law for conduct relating 
to the regulation of a drug product.
    As a result of the foregoing finding, Dr. James Michael Anthony is 
permanently debarred from providing services in any capacity to a 
person with an approved or pending drug product application under 
sections 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 November 7, 1997 (sections 306(c)(1)(B) and 
(c)(2)(A)(ii) and 201(dd) (21 U.S.C. 321(dd))). Any person with an 
approved or pending drug product application who knowingly uses the 
services of Dr. Anthony, 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 Dr. Anthony, 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 Dr. Anthony during his period of debarment.
    Any application by Dr. Anthony for termination of debarment under 
section 306(d)(4) of the act should be identified with Docket No. 93N-
0451 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: October 29, 1997,
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 97-29399 Filed 11-6-97; 8:45 am]
BILLING CODE 4160-01-F