I 
111TH CONGRESS 
1ST SESSION H. R. 3932 
To expand the authority of the Secretary of Health and Human Services 
to impose debarments in order to ensure the integrity of drug, biological 
product, and device regulation, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
OCTOBER 27, 2009 
Mr. BARTON of Texas (for himself, Mr. SHIMKUS, Mrs. BONO MACK, Mr. 
TERRY, Mr. SULLIVAN, Mr. BURGESS, Mrs. BLACKBURN, and Mr. WAL-
DEN) introduced the following bill; which was referred to the Committee 
on Energy and Commerce 
A BILL 
To expand the authority of the Secretary of Health and 
Human Services to impose debarments in order to ensure 
the integrity of drug, biological product, and device regu-
lation, and for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Strengthening of FDA 
Integrity Act of 2009’’. 
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SEC. 2. DEBARMENT. 
(a) APPLICATION
TO DRUGS, BIOLOGICAL PROD-
UCTS, AND DEVICES.—The Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 301 et seq.) is amended— 
(1) in section 201, by amending subsection (dd) 
to read as follows: 
‘‘(dd) The term ‘drug product’— 
‘‘(1) for purposes of sections 306 and 307, 
means a drug subject to regulation under section 
505, 512, or 802 of this Act or under section 351 
of the Public Health Service Act; and 
‘‘(2) for purposes of section 306, includes a de-
vice subject to regulation under section 513 of this 
Act.’’; and 
(2) in section 306— 
(A) by striking the term ‘‘an abbreviated 
drug application’’ each place such term appears 
and inserting ‘‘a covered application’’; 
(B) by striking the terms ‘‘abbreviated 
drug application’’ and ‘‘abbreviated drug appli-
cations’’ each place either such term appears 
and inserting ‘‘covered application’’ and ‘‘cov-
ered applications’’, respectively; 
(C) by striking the term ‘‘drug product ap-
plication’’ each place such term appears and in-
serting ‘‘covered application’’; 
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(D) in the heading of subsections (a) and 
(b), by striking ‘‘CERTAIN DRUG APPLICA-
TIONS’’ and inserting ‘‘CERTAIN DRUG PROD-
UCT APPLICATIONS’’; 
(E) in subsection (b)(2)(B)(i), by striking 
‘‘the process for the regulation of drugs’’ and 
inserting ‘‘the process for the regulation of drug 
products’’; 
(F) in subsection (d)(4)(B)(ii), by striking 
‘‘of any drug subject to sections 505’’ and in-
serting ‘‘of any drug product’’; 
(G) in subsections (b)(2)(A), (b)(2)(B)(iv), 
(c)(3)(C), 
(c)(3)(E), 
(d)(3)(A)(ii)(II), 
(d)(3)(B)(ii), 
(d)(4)(B)(iv), 
(d)(4)(D)(ii), 
(f)(1)(B)(ii), (g), and (h), by striking the terms 
‘‘drug’’ and ‘‘drugs’’ each place either such 
term appears and inserting ‘‘drug product’’ and 
‘‘drug products’’, respectively; and 
(H) by adding at the end the following: 
‘‘(n) COVERED APPLICATION DEFINED.—In this sec-
tion, the term ‘covered application’ means— 
‘‘(1) an application for approval or licensure of 
a drug under section 505 of this Act or section 351 
of the Public Health Service Act, respectively; or 
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‘‘(2) an application for clearance or approval of 
a device under section 510(k) or 515 of this Act, re-
spectively.’’. 
(b) MANDATORY DEBARMENT.—Paragraph (1) of 
section 306(a) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 335a(a)) is amended to read as follows: 
‘‘(1) CORPORATIONS, PARTNERSHIPS, AND AS-
SOCIATIONS.—If the Secretary finds that a person 
other than an individual has been convicted, after 
May 13, 1992, of a felony under Federal law for 
conduct— 
‘‘(A) relating to the development or ap-
proval, including the process for development or 
approval, of any drug product, or 
‘‘(B) otherwise relating to the regulation of 
any drug product under this Act or subpart 1 
of part F of title III of the Public Health Serv-
ice Act, 
the Secretary shall debar such person from submit-
ting, or assisting in the submission of, any covered 
application.’’. 
(c) PERMISSIVE DEBARMENT.—Section 306(b)(2) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
335a(b)(2)) is amended— 
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