11/07/1997

[Federal Register: November 7, 1997 (Volume 62, Number 216)]

[Notices]

[Page 60249-60250]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr07no97-69]

 

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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