[Federal Register Volume 74, Number 112 (Friday, June 12, 2009)]
[Notices]
[Page 28049]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-13929]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0137]


Mary E. Sawaya a.k.a. Marty Sawaya; 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. Mary E. Sawaya a.k.a. Marty Sawaya (Dr. Sawaya) 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. Sawaya 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, and conduct otherwise 
relating to the regulation 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. 
Sawaya failed to request a hearing. Dr. Sawaya's failure to request a 
hearing constitutes a waiver of her right to a hearing concerning this 
action.

DATES: This order is effective June 12, 2009.

ADDRESSES: Submit applications for special 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:  Robert L. Hummel, Sr., Division of 
Compliance Policy (HFC-230), Office of Enforcement, Office of 
Regulatory Affairs, Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 240-632-6845.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 306(a)(2)(A) of the act (21 U.S.C. 335a(a)(2)(A)) requires 
debarment of an individual if FDA finds that the individual 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 any drug product. Section 306(a)(2)(B) of the act requires 
debarment of an individual if FDA finds that the individual has been 
convicted of a felony under Federal law for conduct otherwise relating 
to the regulation of any drug product under the act.
    On December 11, 2003, the U.S. District Court for the Middle 
District of Florida accepted Dr. Mary E. Sawaya's plea of guilty and 
convicted her of one count of making a false statement to a Federal 
agency, a Federal felony offense under 18 U.S.C. 1001. This offense was 
committed when Dr. Sawaya created a medical license by obtaining a copy 
of a colleague's Florida medical license, altered that license using a 
photocopy machine to reflect that the license was issued in her name, 
and submitted the false and fraudulent Florida medical license to the 
sponsor of a clinical trial, for which she was a clinical investigator. 
The sponsor submitted that license to FDA as part of the drug approval 
process. When the false license was due to expire, Dr. Sawaya once 
again created a false and fraudulent medical license with a different 
expiration date and submitted that license to the clinical trial 
sponsor.
    As a result of this conviction, FDA sent Dr. Sawaya by certified 
mail on November 26, 2008, a notice proposing to permanently debar her 
from providing services in any capacity to a person that has an 
approved or pending drug product application. The proposal was based on 
a finding, under section 306(a)(2)(A) and (a)(2)(B) of the act, that 
Dr. Sawaya 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, and conduct otherwise 
relating to the regulation of a drug product under the act. The 
proposal also offered Dr. Sawaya an opportunity to request a hearing, 
providing her 30 days from the date of receipt of the letter in which 
to file the request, and advised her that failure to request a hearing 
constituted a waiver of the opportunity for a hearing and of any 
contentions concerning this action. Dr. Sawaya did not request a 
hearing and has, therefore, waived her opportunity for a hearing and 
any contentions concerning her debarment (21 CFR part 12).

II. Findings and Order

    Therefore, the Acting Director, Office of Enforcement, Office of 
Regulatory Affairs, under section 306(a)(2)(A) and (a)(2)(B) of the 
act, and under authority delegated to her, finds that Dr. Sawaya 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 and conduct otherwise relating to the 
regulation of a drug product under the act.
    As a result of the foregoing finding, Dr. Sawaya is permanently 
debarred from providing services in any capacity to a person with an 
approved or pending drug product application 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), effective (see 
DATES). (See sections 306(c)(1)(B) and (c)(2)(A)(ii) and 201(dd) of the 
act (21 U.S.C. 321(dd)).) Any person with an approved or pending drug 
product application who knowingly employs or retains as a consultant or 
contractor, or otherwise uses the services of Dr. Sawaya, in any 
capacity, during Dr. Sawaya'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. Sawaya , during her period of debarment, provides 
services in any capacity to a person with an approved or pending drug 
product application, she 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 submitted by or with the 
assistance of Dr. Sawaya during her period of debarment (section 
306(c)(1)(B) of the act).
    Any application by Dr. Sawaya for special termination of debarment 
under section 306(d)(4) of the act should be identified with Docket No. 
FDA-2008-N-0137 and sent to the Division of Dockets Management (see 
ADDRESSES). 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 Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: June 1, 2009.
Alyson L. Saben,
Acting Director, Office of Enforcement, Office of Regulatory Affairs.
[FR Doc. E9-13929 Filed 6-11-09; 8:45 am]
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