Federal Register / Vol. 74, No. 112 / Friday, June 12, 2009 / Notices 28049 

respondents are encouraged to submit 

comments by fax to: 202–395–6974. 

Dated: June 4, 2009. 

Elaine Parry, 

Director, Office of Program Services. 

[FR Doc. E9–13841 Filed 6–11–09; 8:45 am] 

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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. 

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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