I 
110TH CONGRESS 
2D SESSION 
H. R. 6378 
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 
JUNE 26, 2008 
Mr. BARTON of Texas (for himself, Mr. DEAL of Georgia, Mr. WHITFIELD 
of Kentucky, Mr. SHIMKUS, Mrs. WILSON of New Mexico, Mr. PICK-
ERING, Mrs. BONO MACK, Mr. WALDEN of Oregon, Mr. TERRY, Mr. SUL-
LIVAN, and Mrs. BLACKBURN) 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 2008’’. 
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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.—Section 306(a) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
335a(a)) is amended— 
(1) by amending paragraph (1) to read as fol-
lows: 
‘‘(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.’’; and 
(2) by adding at the end the following new 
paragraph: 
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‘‘(3) INITIATION
OF
DEBARMENT.—The Sec-
retary shall initiate a debarment of a person or indi-
vidual under paragraph (1) or (2), respectively, not 
later than the date that is one year after the date 
such person or individual is convicted of the felony 
described in such respective paragraph.’’. 
(c) PERMISSIVE DEBARMENT.—Section 306(b)(2) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
335a(b)(2)) is amended— 
(1) in subparagraph (A)(i), by amending sub-
clause (I) to read as follows: 
‘‘(I) relates to the development or 
approval, including the process for de-
velopment or approval, of any drug 
product or otherwise relates to the 
regulation of drug products under this 
Act or subpart 1 of part F of title III 
of the Public Health Service Act, 
and’’; 
(2) in subparagraph (B)— 
(A) by striking clauses (ii) and (iii); and 
(B) by redesignating clause (iv) as clause 
(ii); and 
(3) by adding at the end the following: 
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‘‘(C) BRIBERY, FRAUD, AND OTHER SUCH 
CRIMES.—Any person (including any individual) 
whom the Secretary finds has been convicted 
of— 
‘‘(i) a felony which is not described in 
paragraph (1) or (2) of subsection (a) or 
in subparagraph (A) or (B)(i) of this sub-
section and which involves bribery, pay-
ment of illegal gratuities, fraud, perjury, 
false statement, racketeering, blackmail, 
extortion, falsification or destruction of 
records, or interference with or obstruction 
of an investigation into, or prosecution of, 
any criminal offense, or 
‘‘(ii) a conspiracy to commit, or aiding 
or abetting such felony, 
if the Secretary finds, on the basis of the con-
viction of such person and other information, 
that such person has demonstrated a pattern of 
conduct sufficient to find that there is reason to 
believe that such person may violate require-
ments under this Act or subpart 1 of part F of 
title III of the Public Health Service Act relat-
ing to drug products. 
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