I 

110TH CONGRESS 

1ST SESSION H. R. 2273 

To amend the Federal Food, Drug, and Cosmetic Act to provide for the 

deposit in the general fund of the Treasury of fees that are collected 

from manufacturers of drugs and devices under chapter VII of such 

Act, to terminate the authority of the Food and Drug Administration 

to negotiate with the manufacturers on particular uses of the fees, 

to establish a Center for Postmarket Drug Safety and Effectiveness, 

to establish additional authorities to ensure the safe and effective use 

of drugs, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

MAY 10, 2007 

Mr. HINCHEY (for himself, Mr. STUPAK, and Mr. GRIJALVA) introduced the 

following bill; which was referred to the Committee on Energy and Commerce 

A BILL 

To amend the Federal Food, Drug, and Cosmetic Act to 

provide for the deposit in the general fund of the Treasury of fees that are collected from manufacturers of 

drugs and devices under chapter VII of such Act, to 

terminate the authority of the Food and Drug Administration to negotiate with the manufacturers on particular 

uses of the fees, to establish a Center for Postmarket 

Drug Safety and Effectiveness, to establish additional 

authorities to ensure the safe and effective use of drugs, 

and for other purposes. 


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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 ‘‘Food and Drug Ad5 ministration Improvement Act of 2007’’. 

6 SEC. 2. FEES PAID BY MANUFACTURERS TO FOOD AND 

7 DRUG ADMINISTRATION; DEPOSIT IN GEN8 ERAL FUND OF TREASURY; DIRECT SPEND9 ING. 

10 (a) IN GENERAL.—Subchapter C of chapter VII of 

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

12 379f et seq.) is amended by adding at the end the fol13 lowing part: 

14 ‘‘PART 5—MODIFICATIONS REGARDING USER-FEE 

15 PROGRAMS 

16 ‘‘SEC. 740A. DEPOSIT OF FEES IN GENERAL FUND OF 

17 TREASURY; DIRECT SPENDING. 

18 ‘‘(a) DEPOSIT IN GENERAL FUND.—Notwithstanding 

19 any other provision of this Act related to the collection 

20 of fees related to drugs, devices, or animal drugs, all such 

21 fees collected under this Act shall be deposited in the gen22 eral fund of the Treasury. 

23 ‘‘(b) DIRECT SPENDING.— 

24 ‘‘(1) IN GENERAL.—Notwithstanding any other 

25 provision of this Act related to the collection of such 


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1 fees, amounts are available to the Secretary for obli2 gation in accordance with the following: 

3 ‘‘(A) The amount authorized to be appro4 priated under this Act for fees related to drugs 

5 is, to the extent described in section 

6 736(g)(2)(A)(ii) (as in effect on September 30, 

7 2007), available to the Secretary for obligation 

8 solely for the process for the review of human 

9 drug applications (within the meaning given to 

10 such term in section 735, as in effect on Sep11 tember 30, 2007). 

12 ‘‘(B) The amount authorized to be appro13 priated under this Act for fees related to de14 vices is, to the extent described in section 

15 738(h)(2)(A)(ii) (as in effect on September 30, 

16 2007), available to the Secretary for obligation 

17 solely for the process for the review of device 

18 applications (within the meaning given to such 

19 terms in section 737, as in effect on September 

20 30, 2007). 

21 ‘‘(C) The amount authorized to be appro22 priated under this Act for fees related to animal 

23 drugs is, to the extent described in section 

24 740(g)(2)(A)(ii) (as in effect on September 30, 

25 2007), available to the Secretary for obligation 


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1 solely for the process for the review of animal 

2 drug applications (within the meaning given to 

3 such terms in section 739, as in effect on Sep4 tember 30, 2007). 

5 ‘‘(2) LIST OF MANDATORY APPROPRIATIONS.— 

6 The program of spending established in paragraph 

7 (1) shall be considered entitlement authority within 

8 the meaning of section 250(17) of the Balanced 

9 Budget and Emergency Deficit Control Act of 1985. 

10 ‘‘SEC. 740B. TERMINATION OF AUTHORITY FOR NEGOTIA11 TIONS WITH MANUFACTURERS ON USE OF 

12 FEES. 

13 ‘‘(a) IN GENERAL.—With respect to persons from 

14 whom fees related to drugs, devices, or animal drugs are 

15 collected under this Act and notwithstanding any other 

16 provision of this Act related to the collection of such fees: 

17 ‘‘(1) On and after the date of the enactment of 

18 the Food and Drug Administration Improvement 

19 Act of 2007: 

20 ‘‘(A) The Secretary may not enter into 

21 agreements with such persons on particular 

22 uses of the fees, including agreements on prior23 ities, performance goals, or other commitments 

24 relating to— 


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1 ‘‘(i) review times for human drug ap2 plications or supplements (within the 

3 meaning given to such terms in section 

4 735, as in effect on September 30, 2007); 

5 ‘‘(ii) review times for premarket appli6 cations, premarket reports, premarket noti7 fication submissions, or supplements (with8 in the meaning given to such terms in sec9 tion 737, as in effect on September 30, 

10 2007); or 

11 ‘‘(iii) review times for animal drug ap12 plications or supplements (within the 

13 meaning given to such terms in section 

14 739, as in effect on September 30, 2007). 

15 ‘‘(B) The Secretary may not otherwise ne16 gotiate understandings with such persons on 

17 particular uses of the fees. 

18 ‘‘(2) On and after October 1, 2007: 

19 ‘‘(A) Any such agreement or under20 standing that was in effect on the day before 

21 the date of the Food and Drug Administration 

22 Improvement Act of 2007 is terminated, includ23 ing agreements or understandings pursuant to 

24 letters referred to in section 502(4) of Public 

25 Law 107–188 (116 Stat. 688), section 101(3) 


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1 of Public Law 107–250 (116 Stat. 1589), and 

2 section 2(3) of Public Law 108–130 (117 Stat. 

3 1361). 

4 ‘‘(B) The Secretary is relieved of responsi5 bility for meeting any particular goals con6 cerning such review times that were established 

7 in such letters. 

8 ‘‘(b) RULES OF CONSTRUCTION.—Subsection (a) 

9 may not be construed— 

10 ‘‘(1) as affecting the responsibility of the Sec11 retary to work toward the general goal of admin12 istering this Act efficiently, including the review of 

13 applications, reports, supplements and other submis14 sions referred to in subsection (a)(1)(A); or 

15 ‘‘(2) as terminating requirements for the collec16 tion of fees under any other provision of this Act.’’. 

17 (b) APPLICABILITY.—Section 740A of the Federal 

18 Food, Drug, and Cosmetic Act, as added by subsection 

19 (a) of this section, applies with respect to fiscal year 2008 

20 and subsequent fiscal years. 

21 SEC. 3. ESTABLISHMENT OF CENTER FOR POSTMARKET 

22 DRUG SAFETY AND EFFECTIVENESS. 

23 (a) IN GENERAL.—Chapter V of the Federal Food, 

24 Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amend25 ed by inserting after section 505B the following sections: 


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1 ‘‘SEC. 505C. CENTER FOR POSTMARKET DRUG SAFETY AND 

2 EFFECTIVENESS. 

3 ‘‘(a) ESTABLISHMENT.—Not later than 180 days 

4 after the date of the enactment of the Food and Drug 

5 Administration Improvement Act of 2007, the Secretary 

6 shall establish within the Food and Drug Administration 

7 a center to be known as the Center for Postmarket Drug 

8 Safety and Effectiveness (referred to in this section as the 

9 ‘Center’), which shall be headed by a director appointed 

10 by the Secretary (without regard to the delegation to the 

11 Commissioner of Food and Drugs under section 

12 903(d)(2)). The Center shall be established as a separate 

13 center at the organizational level immediately below the 

14 Office of the Commissioner. The Director of the Center 

15 shall report directly to the Commissioner. 

16 ‘‘(b) DUTIES.— 

17 ‘‘(1) IN GENERAL.—The Director of the Center 

18 shall have the principal responsibility within the 

19 Food and Drug Administration, below the Office of 

20 the Commissioner, for assisting the Commissioner in 

21 regulating approved drugs, other than with respect 

22 to section 501. Such assistance includes assistance 

23 with the following: 

24 ‘‘(A) Administering enforcement authori25 ties under chapter III, including civil penalties 

26 under section 303(f). 


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1 ‘‘(B) Administering section 502. 

2 ‘‘(C) Administering requirements for stud3 ies that were required as conditions for the ap4 proval of applications under section 505 (which 

5 studies are conducted after such approval). 

6 ‘‘(D) Administering authorities under sec7 tions 505D and 505E. 

8 ‘‘(E) Monitoring approved drugs to deter9 mine whether there are any issues regarding 

10 safety and effectiveness. 

11 ‘‘(F) With respect to issues identified 

12 under subparagraph (E), taking action under 

13 the provisions referred to in subparagraphs (A) 

14 through (D), including as appropriate the fol15 lowing: 

16 ‘‘(i) Establishing requirements for ad17 vertising under section 502(n). 

18 ‘‘(ii) Establishing requirements for 

19 modifications in labeling under section 

20 502(x), including the specification of a 

21 date by which the modifications are re22 quired to be made. 

23 ‘‘(iii) Withdrawing the approval of 

24 drugs under section 505(e). 


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1 ‘‘(iv) Requiring reports under section 

2 505(k) on clinical experience with approved 

3 drugs, including reports on the number of 

4 individuals using the drugs as indicated by 

5 sales of the drugs at retail and reports on 

6 information possessed by manufacturers on 

7 usage of the drugs. 

8 ‘‘(v) Requiring notifications under sec9 tion 505D(a)(1) to eliminate unreasonable 

10 risks of substantial harm to the public 

11 health. 

12 ‘‘(vi) Establishing restrictions under 

13 section 505D(a)(2) to ensure the safe use 

14 of approved drugs, including requirements 

15 for— 

16 ‘‘(I) the specific manner of ob17 taining the informed consent of pa18 tients to undergo treatment with the 

19 drugs; 

20 ‘‘(II) providing education to phy21 sicians; 

22 ‘‘(III) providing education to pa23 tients; and 

24 ‘‘(IV) the establishment of risk25 management plans by manufacturers. 


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1 ‘‘(vii) Requiring the conduct of studies 

2 under section 505E. 

3 ‘‘(2) TRANSFERS.—The Secretary shall transfer 

4 to the Center all responsibilities for the matters re5 ferred to in paragraph (1) that, on the day before 

6 the date of the enactment of the Food and Drug Ad7 ministration Improvement Act of 2007, were vested 

8 in the Center for Drug Evaluation and Research and 

9 the Center for Biologics Evaluation and Research. 

10 ‘‘(c) INTERACTIONS WITH OTHER CENTERS.— 

11 ‘‘(1) CONSULTATION.—The Director of the 

12 Center shall carry out this section in consultation 

13 with the Directors of the Centers referred to in sub14 section (b)(2). 

15 ‘‘(2) ACCESS TO INFORMATION.—The Secretary 

16 shall ensure that the Director of the Center has full 

17 access to all information possessed by the Food and 

18 Drug Administration that relates to the safety and 

19 effectiveness of approved drugs, including informa20 tion possessed by the Centers referred to in sub21 section (b)(2). 

22 ‘‘(d) DEFINITION.—For purposes of this section, the 

23 term ‘approved drug’ means a drug for which an approved 

24 application under section 505 is in effect or for which a 


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1 biologics license under section 351 of the Public Health 

2 Service Act is in effect. 

3 ‘‘(e) FUNDING.—For the purpose of carrying out this 

4 section, the Secretary shall make available for a fiscal 

5 year, from the amount appropriated for the Food and 

6 Drug Administration for such year, the following amount, 

7 as applicable to such year: 

8 ‘‘(1) For fiscal year 2008, $100,000,000. 

9 ‘‘(2) For fiscal year 2009, $125,000,000. 

10 ‘‘(3) For fiscal year 2010, $150,000,000. 

11 ‘‘(4) For fiscal year 2011, $175,000,000. 

12 ‘‘(5) For fiscal year 2012, $200,000,000. 

13 ‘‘SEC. 505D. CERTAIN POSTMARKET AUTHORITIES. 

14 ‘‘(a) IN GENERAL.—Effective on and after the date 

15 of the enactment of the Food and Drug Administration 

16 Improvement Act of 2007, the Secretary has with respect 

17 to approved drugs the same authorities as the Secretary 

18 has with respect to devices under the following provisions: 

19 ‘‘(1) Section 518(a) (relating to notifications to 

20 eliminate an unreasonable risk of substantial harm 

21 to the public health). 

22 ‘‘(2) Section 520(e)(1)(B) (relating to restric23 tions on sale, distribution, or use). 


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1 ‘‘(3) Section 520(h) (relating to making avail2 able to the public summaries of information respect3 ing safety and effectiveness). 

4 ‘‘(b) DEFINITION.—For purposes of this section, the 

5 term ‘approved drug’ has the meaning given such term 

6 in section 505C(d). 

7 ‘‘SEC. 505E. POSTMARKET STUDIES REGARDING SAFETY OF 

8 DRUGS. 

9 ‘‘(a) PHASE 4 STUDIES.—The Secretary may require 

10 that the manufacturer of an approved drug conduct one 

11 or more studies to confirm or refute an empirical or theo12 retical hypothesis of a significant safety issue with the 

13 drug (whether raised with respect to the product directly 

14 or with respect to the class of the product) that has been 

15 identified pursuant to— 

16 ‘‘(1) the MedWatch postmarket surveillance 

17 system; 

18 ‘‘(2) a clinical or epidemiological study; 

19 ‘‘(3) the scientific literature; 

20 ‘‘(4) a foreign government that regulates drugs 

21 or devices; 

22 ‘‘(5) an international organization concerned 

23 with the safety or effectiveness of drugs or devices; 

24 or 


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1 ‘‘(6) such other sources as the Secretary deter2 mines to be appropriate. 

3 ‘‘(b) APPROVAL OF PROTOCOL; TIMEFRAME.—A 

4 study under subsection (a) shall be conducted in accord5 ance with a protocol approved by the Secretary. In requir6 ing such a study, the Secretary shall specify a timeframe 

7 for completing the study. 

8 ‘‘(c) PUBLIC DISCLOSURE.— 

9 ‘‘(1) INTERNET SITE.—Notwithstanding section 

10 506B, the Secretary shall maintain on the Internet 

11 site of the Food and Drug Administration a data12 base that provides information on each study re13 quired under subsection (a), including a description 

14 of and the reason for the study, the required comple15 tion date, and whether the study has been com16 pleted. The Secretary shall update the database not 

17 less frequently than once each quarter. 

18 ‘‘(2) FEDERAL REGISTER.—Not later than 30 

19 days after first establishing the database under 

20 paragraph (1), the Secretary shall, with respect to 

21 studies required under subsection (a), publish in the 

22 Federal Register the same information as is included 

23 in such database as of the date of such publication. 

24 Thereafter, the Secretary shall publish in the Fed25 eral Register, not less frequently than once each 


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1 quarter, updates that reflect the updates made 

2 under paragraph (1). 

3 ‘‘(d) DEFINITION.—For purposes of this section, the 

4 term ‘approved drug’ has the meaning given such term 

5 in section 505C(d).’’. 

6 (b) CERTAIN STUDIES.— 

7 (1) IN GENERAL.—With respect to section 

8 505E(c) of the Federal Food, Drug, and Cosmetic 

9 Act (as added by subsection (a) of this section), each 

10 study described in paragraph (2) is deemed to be a 

11 study to which such section applies. 

12 (2) RELEVANT STUDIES.—For purposes of 

13 paragraph (1), a study described in this paragraph 

14 is a study that— 

15 (A) relates to the safety or effectiveness of 

16 a drug; 

17 (B) was in progress as of the date of the 

18 enactment of this Act; and 

19 (C) was conducted pursuant to an agree20 ment that, on or after January 1, 2003, was 

21 entered into with the Secretary of Health and 

22 Human Services, acting through the Commis23 sioner of Food and Drugs. 


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1 SEC. 4. ORDER REGARDING POSTMARKET LABELING. 

2 Section 502 of the Federal Food, Drug, and Cosmetic 

3 Act (21 U.S.C. 352) is amended by adding at the end the 

4 following: 

5 ‘‘(y) If it is a drug and the Secretary deter6 mines that its labeling fails to provide information, 

7 including specific wording, required by the Secretary 

8 by order on the basis that the information is nec9 essary to ensure its safe and effective use.’’. 

10 SEC. 5. ADDITIONAL ENFORCEMENT PROVISIONS. 

11 (a) POSTMARKET AUTHORITIES.—Section 502 of the 

12 Federal Food, Drug, and Cosmetic Act, as amended by 

13 section 4 of this Act, is amended by adding at the end 

14 the following: 

15 ‘‘(y) If it is a drug with respect to which there is 

16 a failure to comply with any requirement under section 

17 505D or 505E.’’. 

18 (b) CIVIL PENALTIES FOR VIOLATIONS OF REQUIRE19 MENTS RELATING TO DRUGS.—Section 303(f) of the Fed20 eral Food, Drug, and Cosmetic Act (21 U.S.C. 333(f)) is 

21 amended— 

22 (1) by redesignating paragraphs (3) through 

23 (5) as paragraphs (4) through (6), respectively; 

24 (2) by inserting after paragraph (2) the fol25 lowing paragraph: 


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1 ‘‘(3) Any person who violates a requirement of 

2 this Act which relates to drugs shall be liable to the 

3 United States for a civil penalty in an amount not 

4 exceeding $50,000 per day for each such violation, 

5 not to exceed $50,000,000 for all such violations ad6 judicated in a single proceeding.’’; 

7 (3) in paragraph (4) (as so redesignated) by 

8 striking ‘‘paragraph (1) or (2)’’ each place such 

9 term appears and inserting ‘‘paragraph (1), (2), or 

10 (3)’’; 

11 (4) in paragraph (5) (as so redesignated), by 

12 striking ‘‘paragraph (3)(A)’’ and inserting ‘‘para13 graph (4)(A)’’; and 

14 (5) in paragraph (6) (as so redesignated), by 

15 striking ‘‘paragraph (4)’’ each place such term ap16 pears and inserting ‘‘paragraph (5)’’. 

17 SEC. 6. PREEMPTION. 

18 (a) IN GENERAL.—With respect to the issue of 

19 whether a provision of chapter V of the Federal Food, 

20 Drug, and Cosmetic Act or of section 351 of the Public 

21 Health Service Act (or regulations or orders under such 

22 a provision) supersedes the law of a State, the Secretary 

23 of Health and Human Services (referred to in this section 

24 as the ‘‘Secretary’’) shall follow, without change, the inter25 pretation that was followed by the Food and Drug AdminVerDate Aug 31 2005 22:10 May 11, 2007 Jkt 059200 PO 00000 Frm 00016 Fmt 6652 Sfmt 6201 E:\BILLS\H2273.IH H2273

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1 istration in 1999, including the interpretation that such 

2 Administration ‘‘does not believe that the evolution of 

3 state tort law will cause the development of standards that 

4 would be at odds with the agency’s regulations’’ and that 

5 such regulations ‘‘establish minimal standards’’ but are 

6 not intended to preclude the States from imposing addi7 tional requirements (63 FR 66384). 

8 (b) PRODUCT LIABILITY CASES.—In the case of civil 

9 actions regarding product liability that are brought in 

10 State courts against manufacturers of drugs or devices, 

11 policies of the Secretary required under subsection (a) in12 clude the policy that the Secretary cease intervening in 

13 such actions to argue any interpretation contrary to such 

14 subsection. 

15 SEC. 7. ADDITIONAL PROVISIONS. 

16 (a) REQUIREMENTS REGARDING MEMBERSHIP OF

17 ADVISORY COMMITTEES.—Subchapter A of chapter VII of 

18 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371 

19 et seq.) is amended by adding at the end the following 

20 section: 

21 ‘‘SEC. 712. REQUIREMENTS REGARDING MEMBERSHIP OF 

22 ADVISORY COMMITTEES. 

23 ‘‘(a) IN GENERAL.—Notwithstanding any other pro24 vision of law, the Secretary shall comply with the following 


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1 with respect to any meeting of an advisory committee con2 vened by the Secretary under this Act: 

3 ‘‘(1) Not later than 30 days before such meet4 ing, the Secretary shall post on the Internet site of 

5 the Food and Drug Administration the agenda for 

6 the meeting and the tentative list of all proposed ad7 visory committee members, together with a short bi8 ography of each such prospective member. 

9 ‘‘(2) After compliance with paragraph (1), the 

10 Secretary shall provide the public not fewer than 20 

11 days to submit to the Secretary comments on the 

12 proposed membership of the advisory committee. 

13 ‘‘(3) The Secretary shall consider the public 

14 comments to determine whether any adjustment to 

15 the roster of the advisory committee is necessary to 

16 make the committee fairly balanced. 

17 ‘‘(4) Not later than three days before the start 

18 of the meeting, the Secretary shall post on such 

19 Internet site the final membership of the advisory 

20 committee. 

21 ‘‘(b) CONFLICTS OF INTEREST.—Notwithstanding 

22 any other provision of law, a member of an advisory com23 mittee under this Act may not, with respect to service on 

24 such committee, be granted an exemption under section 


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1 208(b) of title 18, United States Code (relating to per2 sonal financial interests). 

3 ‘‘(c) DEFINITIONS.—For purposes of this section: 

4 ‘‘(1) The term ‘advisory committee’ has the 

5 same meaning given such term in section 3(2) of the 

6 Federal Advisory Committee Act. 

7 ‘‘(2) The term ‘fairly balanced’ has the same 

8 meaning as applies to such term under section 

9 5(b)(2) of the Federal Advisory Committee Act.’’. 

10 (b) CERTAIN USES OF APPROVED DRUGS.—Chapter 

11 IX of the Federal Food, Drug, and Cosmetic Act (21 

12 U.S.C. 391 et seq.) is amended by adding at the end the 

13 following section: 

14 ‘‘SEC. 910. REQUIREMENT REGARDING INFORMED CON15 SENT FOR CERTAIN TREATMENTS. 

16 ‘‘With respect to the prescribing of a drug for a use 

17 not included in the approved labeling for the drug under 

18 section 505 or under section 351 of the Public Health 

19 Service Act, the Secretary shall promulgate regulations re20 quiring that, before prescribing the drug— 

21 ‘‘(1) the physician inform the patient that the 

22 use for which the physician intends to prescribe the 

23 drug has not been approved by the Food and Drug 

24 Administration; and 


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1 ‘‘(2) the physician obtain from the patient an 

2 acknowledgment of such fact and the consent of the 

3 patient to use the drug for such use notwithstanding 

4 such fact.’’. 

Æ 


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