I 
110TH CONGRESS 
2D SESSION 
H. R. 6376 
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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‘‘(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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(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: 
‘‘(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, 
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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. 
‘‘(D) 
MATERIAL
PARTICIPATION.—Any 
person (including any individual) whom the 
Secretary finds materially participated in acts 
that were the basis for a conviction for an of-
fense described in paragraph (1) or (2) of sub-
section (a) or in subparagraph (A), (B)(i), or 
(C) of this subsection for which a conviction 
was obtained, if the Secretary finds, on the 
basis of such participation and other informa-
tion, that such individual has demonstrated a 
pattern of conduct sufficient to find that there 
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is reason to believe that such person may vio-
late requirements under this Act or subpart 1 
of part F of title III of the Public Health Serv-
ice Act relating to drug products.’’. 
(d) ADDITIONAL DEBARMENT CONSIDERATION.— 
Paragraph (3) of subsection (c) of section 306 of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 
335a(c)(3)) is amended— 
(1) by striking ‘‘and’’ at the end of subpara-
graph (E); 
(2) by striking the period at the end of sub-
paragraph (F) and inserting ‘‘, and’’; and 
(3) by adding at the end the following new sub-
paragraph: 
‘‘(G) whether debarment of the person will 
affect the public health because sufficient quan-
tities of the drug product would not be avail-
able.’’. 
(e) EFFECTIVE DATES.—Paragraph (2) of section 
306(l) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 335a(l)) is amended by striking the phrase ‘‘oc-
curred more than 5 years before’’ each place such phrase 
appears and inserting ‘‘occurred more than 1 year before’’. 
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(f) ANNUAL REPORT.—Section 306 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 335a) is 
amended by adding at the end the following: 
‘‘(o) ANNUAL REPORT.—Each year, the Secretary 
shall submit a report to the Congress on implementation 
of this section. Each such report shall identify— 
‘‘(1) debarment proceedings mandated under 
subsection (a) or (m); 
‘‘(2) debarment proceedings initiated under 
subsection (a), (b), or (m); 
‘‘(3) the status of debarment proceedings so ini-
tiated or pending from a previous year; 
‘‘(4) debarments imposed under this section; 
and 
‘‘(5) debarments declined under this section.’’. 
(g) CONFORMING AMENDMENTS.—Section 306 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 335a) 
is amended— 
(1) in subsections (a)(2)(B) and (h)(1)(A), by 
striking ‘‘this Act’’ and inserting ‘‘this Act or sub-
part 1 of part F of title III of the Public Health 
Service Act’’; 
(2) in subsection (b)(2)(A)(i)(II), by striking 
‘‘the date of the enactment of this section’’ and in-
serting ‘‘May 13, 1992’’; 
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