FR DATE: 11/24/2008

[Federal Register: November 24, 2008 (Volume 73, Number 227)]

[Notices]               
[Page 71008-71009]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24no08-110]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-N-0488] (formerly Docket No. 2007N-0291)

 
Roy Page, M.D.; 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. Roy Page from providing services in any capacity to a 
person that has an approved or pending drug product application 
including, but not limited to, a biologics license application. FDA 
bases this order on a finding that Dr. Page 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 
under the act. After being given notice of the proposed permanent 
debarment and an opportunity to request a hearing within the timeframe 
prescribed by regulation, Dr. Page failed to request a hearing. Dr. 
Page's failure to request a hearing constitutes a waiver of his right 
to a hearing concerning this action.

DATES: This order is effective November 24, 2008.

ADDRESSES: Submit applications for termination of debarment to the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Jennifer J. Ross, Center for Biologics 
Evaluation and Research (HFM-10), Food and Drug Administration, 1401 
Rockville Pike, Rockville, MD 20852-1448, 301-827-0372.

[[Page 71009]]


SUPPLEMENTARY INFORMATION:

I. Background

    On August 4, 2005, the U.S. District Court for the Western District 
of Tennessee accepted Dr. Roy Page's guilty plea to one count of 
introduction and delivery for introduction into interstate commerce of 
a misbranded drug with the intent to mislead the FDA, a Federal felony 
offense under sections 301(a) and 303(a)(2) of the act (21 U.S.C. 
331(a) and 333(a)(2). This offense was committed when Dr. Page shipped 
tumor tissue and blood samples to Amscot Medical Laboratories, Inc., 
for manufacture of a new drug for the treatment of cancer in human 
beings without an investigational new drug application in effect.
    As a result of this conviction, FDA sent Dr. Page by certified mail 
on September 7, 2007, a notice proposing to permanently debar Dr. Page 
from providing services in any capacity to a person that has an 
approved or pending drug product application including, but not limited 
to, a biologics license application. The proposal also offered Dr. Page 
an opportunity for a hearing on the proposal. The proposal was based on 
a finding, under section 306(a)(2)(A) and (c)(2)(A)(ii) of the act (21 
U.S.C. 335a(a)(2)(A) and (c)(2)(A)(ii)), that Dr. Page 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. Dr. Page was provided 30 days to file objections and request a 
hearing. Dr. Page did not request a hearing. Dr. Page's failure to 
request a hearing constitutes a waiver of his opportunity for a hearing 
and a waiver of any contentions concerning his debarment (21 CFR part 
12).

II. Findings and Order

    Therefore, the Director of the Center for Biologics Evaluation and 
Research, under section 306(a)(2)(A) of the act, and under authority 
delegated to the Director (FDA Staff Manual Guide 1410.35), finds that 
Dr. Page has been 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.
    As a result of the foregoing finding, Dr. Page is permanently 
debarred from providing services in any capacity to a person with an 
approved or pending drug product application (section 306(c)(1)(B) of 
the act). A drug product means a drug, including a biological product, 
subject to regulation under sections 505, 512, or 802 of the act (21 
U.S.C. 355, 360b, or 382), or under section 351 of the Public Health 
Service Act (42 U.S.C. 262). Any person with an approved or pending 
drug product application including, but not limited to, a biologics 
license application, who knowingly employs or retains as a consultant 
or contractor, or otherwise uses the services of Dr. Page, in any 
capacity, during Dr. Page's permanent debarment, will be subject to 
civil money penalties (section 307(a)(6) of the act (21 U.S.C. 
335b(a)(6))). If Dr. Page, during his permanent debarment, provides 
services in any capacity to a person with an approved or pending drug 
product application including, but not limited to, a biologics license 
application, Dr. Page will be subject to civil money penalties (section 
307(a)(7) of the act). In addition, FDA will not accept or review any 
abbreviated drug applications submitted by or with the assistance of 
Dr. Page during Dr. Page's permanent debarment (section 306(c)(1)(B) of 
the act).
    Any application by Dr. Page for termination of debarment under 
section 306(d)(4) of the act should be identified with Docket No. FDA-
2007-N-0488 (formerly Docket No. 2007N-0291) and sent to the Division 
of Dockets Management (see ADDRESSES). All such submissions are to be 
filed in four copies (Sec.  10.20(a) (21 CFR 10.20(a))). The public 
availability of information in these submissions is governed by Sec.  
10.20(j). Publicly available submissions may be seen in the Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday 
(Sec.  10.20(j)(1)).

    Dated: November 12, 2008.
Jesse Goodman,
Director, Center for Biologics Evaluation and Research.
[FR Doc. E8-27803 Filed 11-21-08; 8:45 am]

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