Inspections, Compliance, Enforcement, and Criminal Investigations

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]


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.


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:

  1. 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).
  2. 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]

BILLING CODE 4160-01-S

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