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. WALDEN) 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 regulation, and for other purposes. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Strengthening of FDA 

5 Integrity Act of 2009’’. 


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1 SEC. 2. DEBARMENT. 

2 (a) APPLICATION TO DRUGS, BIOLOGICAL PROD3 UCTS, AND DEVICES.—The Federal Food, Drug, and Cos4 metic Act (21 U.S.C. 301 et seq.) is amended— 

5 (1) in section 201, by amending subsection (dd) 

6 to read as follows: 

7 ‘‘(dd) The term ‘drug product’— 

8 ‘‘(1) for purposes of sections 306 and 307, 

9 means a drug subject to regulation under section 

10 505, 512, or 802 of this Act or under section 351 

11 of the Public Health Service Act; and 

12 ‘‘(2) for purposes of section 306, includes a de13 vice subject to regulation under section 513 of this 

14 Act.’’; and 

15 (2) in section 306— 

16 (A) by striking the term ‘‘an abbreviated 

17 drug application’’ each place such term appears 

18 and inserting ‘‘a covered application’’; 

19 (B) by striking the terms ‘‘abbreviated 

20 drug application’’ and ‘‘abbreviated drug appli21 cations’’ each place either such term appears 

22 and inserting ‘‘covered application’’ and ‘‘cov23 ered applications’’, respectively; 

24 (C) by striking the term ‘‘drug product ap25 plication’’ each place such term appears and in26 serting ‘‘covered application’’; 


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1 (D) in the heading of subsections (a) and 

2 (b), by striking ‘‘CERTAIN DRUG APPLICA3 TIONS’’ and inserting ‘‘CERTAIN DRUG PROD4 UCT APPLICATIONS’’; 

5 (E) in subsection (b)(2)(B)(i), by striking 

6 ‘‘the process for the regulation of drugs’’ and 

7 inserting ‘‘the process for the regulation of drug 

8 products’’; 

9 (F) in subsection (d)(4)(B)(ii), by striking 

10 ‘‘of any drug subject to sections 505’’ and in11 serting ‘‘of any drug product’’; 

12 (G) in subsections (b)(2)(A), (b)(2)(B)(iv), 

13 (c)(3)(C), (c)(3)(E), (d)(3)(A)(ii)(II), 

14 (d)(3)(B)(ii), (d)(4)(B)(iv), (d)(4)(D)(ii), 

15 (f)(1)(B)(ii), (g), and (h), by striking the terms 

16 ‘‘drug’’ and ‘‘drugs’’ each place either such 

17 term appears and inserting ‘‘drug product’’ and 

18 ‘‘drug products’’, respectively; and 

19 (H) by adding at the end the following: 

20 ‘‘(n) COVERED APPLICATION DEFINED.—In this sec21 tion, the term ‘covered application’ means— 

22 ‘‘(1) an application for approval or licensure of 

23 a drug under section 505 of this Act or section 351 

24 of the Public Health Service Act, respectively; or 


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1 ‘‘(2) an application for clearance or approval of 

2 a device under section 510(k) or 515 of this Act, re3 spectively.’’. 

4 (b) MANDATORY DEBARMENT.—Paragraph (1) of 

5 section 306(a) of the Federal Food, Drug, and Cosmetic 

6 Act (21 U.S.C. 335a(a)) is amended to read as follows: 

7 ‘‘(1) CORPORATIONS, PARTNERSHIPS, AND AS8 SOCIATIONS.—If the Secretary finds that a person 

9 other than an individual has been convicted, after 

10 May 13, 1992, of a felony under Federal law for 

11 conduct— 

12 ‘‘(A) relating to the development or ap13 proval, including the process for development or 

14 approval, of any drug product, or 

15 ‘‘(B) otherwise relating to the regulation of 

16 any drug product under this Act or subpart 1 

17 of part F of title III of the Public Health Serv18 ice Act, 

19 the Secretary shall debar such person from submit20 ting, or assisting in the submission of, any covered 

21 application.’’. 

22 (c) PERMISSIVE DEBARMENT.—Section 306(b)(2) of 

23 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

24 335a(b)(2)) is amended— 


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1 (1) in subparagraph (A)(i), by amending sub2 clause (I) to read as follows: 

3 ‘‘(I) relates to the development or 

4 approval, including the process for de5 velopment or approval, of any drug 

6 product or otherwise relates to the 

7 regulation of drug products under this 

8 Act or subpart 1 of part F of title III 

9 of the Public Health Service Act, 

10 and’’; 

11 (2) in subparagraph (B)— 

12 (A) by striking clauses (ii) and (iii); and 

13 (B) by redesignating clause (iv) as clause 

14 (ii); and 

15 (3) by adding at the end the following: 

16 ‘‘(C) BRIBERY, FRAUD, AND OTHER SUCH

17 CRIMES.—Any person (including any individual) 

18 whom the Secretary finds has been convicted 

19 of— 

20 ‘‘(i) a felony which is not described in 

21 paragraph (1) or (2) of subsection (a) or 

22 in subparagraph (A) or (B)(i) of this sub23 section and which involves bribery, pay24 ment of illegal gratuities, fraud, perjury, 

25 false statement, racketeering, blackmail, 


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1 extortion, falsification or destruction of 

2 records, or interference with or obstruction 

3 of an investigation into, or prosecution of, 

4 any criminal offense, or 

5 ‘‘(ii) a conspiracy to commit, or aiding 

6 or abetting such felony, 

7 if the Secretary finds, on the basis of the con8 viction of such person and other information, 

9 that such person has demonstrated a pattern of 

10 conduct sufficient to find that there is reason to 

11 believe that such person may violate require12 ments under this Act or subpart 1 of part F of 

13 title III of the Public Health Service Act relat14 ing to drug products. 

15 ‘‘(D) MATERIAL PARTICIPATION.—Any 

16 person (including any individual) whom the 

17 Secretary finds materially participated in acts 

18 that were the basis for a conviction for an of19 fense described in paragraph (1) or (2) of sub20 section (a) or in subparagraph (A), (B)(i), or 

21 (C) of this subsection for which a conviction 

22 was obtained, if the Secretary finds, on the 

23 basis of such participation and other informa24 tion, that such individual has demonstrated a 

25 pattern of conduct sufficient to find that there 


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1 is reason to believe that such person may vio2 late requirements under this Act or subpart 1 

3 of part F of title III of the Public Health Serv4 ice Act relating to drug products.’’. 

5 (d) ADDITIONAL DEBARMENT CONSIDERATION.— 

6 Paragraph (3) of subsection (c) of section 306 of the Fed7 eral Food, Drug, and Cosmetic Act (21 U.S.C. 

8 335a(c)(3)) is amended— 

9 (1) by striking ‘‘and’’ at the end of subpara10 graph (E); 

11 (2) by striking the period at the end of sub12 paragraph (F) and inserting ‘‘, and’’; and 

13 (3) by adding at the end the following new sub14 paragraph: 

15 ‘‘(G) whether debarment of the person will 

16 affect the public health because sufficient quan17 tities of the drug product would not be avail18 able.’’. 

19 (e) EFFECTIVE DATES.—Paragraph (2) of section 

20 306(l) of the Federal Food, Drug, and Cosmetic Act (21 

21 U.S.C. 335a(l)) is amended by striking the phrase ‘‘oc22 curred more than 5 years before’’ each place such phrase 

23 appears and inserting ‘‘occurred more than 1 year before’’. 


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1 (f) ANNUAL REPORT.—Section 306 of the Federal 

2 Food, Drug, and Cosmetic Act (21 U.S.C. 335a) is 

3 amended by adding at the end the following: 

4 ‘‘(o) ANNUAL REPORT.—Each year, the Secretary 

5 shall submit a report to the Congress on implementation 

6 of this section. Each such report shall identify— 

7 ‘‘(1) debarment proceedings mandated under 

8 subsection (a) or (m); 

9 ‘‘(2) debarment proceedings initiated under 

10 subsection (a), (b), or (m); 

11 ‘‘(3) the status of debarment proceedings so ini12 tiated or pending from a previous year; 

13 ‘‘(4) debarments imposed under this section; 

14 and 

15 ‘‘(5) debarments declined under this section.’’. 

16 (g) CONFORMING AMENDMENTS.—Section 306 of the 

17 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 335a) 

18 is amended— 

19 (1) in subsections (a)(2)(B) and (h)(1)(A), by 

20 striking ‘‘this Act’’ and inserting ‘‘this Act or sub21 part 1 of part F of title III of the Public Health 

22 Service Act’’; 

23 (2) in subsection (b)(2)(A)(i)(II), by striking 

24 ‘‘the date of the enactment of this section’’ and in25 serting ‘‘May 13, 1992’’; 


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1 (3) in subsection (b)(4), by striking ‘‘clause (iii) 

2 or (iv) of paragraph (2)(B)’’ and inserting ‘‘subpara3 graph (B)(ii) or (D) of paragraph (2)’’; 

4 (4) in subsection (c)(1)(A), by striking ‘‘sub5 section (a)(1) or (b)(2)(A)’’ and inserting ‘‘sub6 section (a)(1) or (b)(1)(A)’’; 

7 (5) in subsection (c)(1)(B), by striking ‘‘sub8 section (a)(2) or (b)(2)(B)’’ and inserting ‘‘sub9 section (a)(2) or (b)(1)(B)’’; 

10 (6) in subsection (d)(3)(A)(i), by striking ‘‘or 

11 paragraph (2)(A) or (3) of subsection (b)’’ and in12 serting ‘‘subparagraph (A) or (C) of subsection 

13 (b)(1)’’; 

14 (7) in subsection (d)(3)(B)(i), by striking 

15 ‘‘clause (i), (ii), (iii), or (iv) of subsection (b)(2)(B) 

16 or subsection (b)(3)’’ and inserting ‘‘subparagraph 

17 (B) or (C) of subsection (b)(1)’’; 

18 (8) in subsection (d)(3)(B)(ii), by striking 

19 ‘‘under subsection (b)(2)(B) or subsection (b)(3)’’ 

20 and inserting ‘‘under subparagraph (B) or (C) of 

21 subsection (b)(1)’’; 

22 (9) in subsection (j)(2), by striking ‘‘clause (iii) 

23 or (iv) of subsection (b)(2)(B)’’ and inserting ‘‘sub24 paragraph (B)(ii) or (D) of subsection (b)(2)’’; and 

25 (10) in subsection (l)(2)— 


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1 (A) by striking ‘‘clauses (i) and (ii) of sub2 section (b)(2)(B)’’ and inserting ‘‘subpara3 graphs (B)(i) and (C) of subsection (b)(2)’’; 

4 (B) by striking ‘‘Clauses (iii) and (iv) of 

5 subsection (b)(2)(B)’’ and inserting ‘‘Subpara6 graphs (B)(ii) and (D) of subsection (b)(2)’’; 

7 and 

8 (C) by striking ‘‘Clause (iv) of subsection 

9 (b)(2)(B)’’ and inserting ‘‘Subparagraph (B)(ii) 

10 of subsection (b)(2)’’. 

Æ 


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