I 

109TH CONGRESS 

1ST SESSION H. R. 2090 

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 4, 2005 

Mr. HINCHEY (for himself, Ms. DELAURO, and Mr. STUPAK) 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 2005’’. 

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 part 2, part 3, and part 4, all fees collected under such 

20 parts shall be deposited in the general fund of the Treas21 ury. 

22 ‘‘(b) DIRECT SPENDING.— 

23 ‘‘(1) IN GENERAL.—Notwithstanding part 2, 

24 part 3, and part 4, amounts are available to the Sec-
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1 retary for obligation in accordance with the fol2 lowing: 

3 ‘‘(A) The amount specified in section 

4 736(g)(3) for a fiscal year is, to the extent de5 scribed in section 736(g)(2)(A)(ii), available to 

6 the Secretary for obligation solely for the proc7 ess for the review of human drug applications 

8 (as defined in section 735). 

9 ‘‘(B) The amount specified in section 

10 738(h)(3) for a fiscal year is, to the extent de11 scribed in section 738(h)(2)(A)(ii), available to 

12 the Secretary for obligation solely for the proc13 ess for the review of device applications (as de14 fined in section 737). 

15 ‘‘(C) The amount specified in section 

16 740(g)(3) for a fiscal year is, to the extent de17 scribed in section 740(g)(2)(A)(ii), available to 

18 the Secretary for obligation solely for the proc19 ess for the review of animal drug applications 

20 (as defined in section 739). 

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

22 The program of spending established in paragraph 

23 (1) shall be considered entitlement authority within 

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

25 Budget and Emergency Deficit Control Act of 1985. 
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1 ‘‘SEC. 740B. TERMINATION OF AUTHORITY FOR NEGOTIA2 TIONS WITH MANUFACTURERS ON USE OF 

3 FEES. 

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

5 whom fees are collected under part 2, part 3, or part 4: 

6 ‘‘(1) Notwithstanding such parts, the following 

7 applies on and after the date of the enactment of the 

8 Food and Drug Administration Improvement Act of 

9 2005: 

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

11 agreements with such persons on particular 

12 uses of the fees, including agreements on prior13 ities, performance goals, or other commitments 

14 relating to— 

15 ‘‘(i) review times for human drug ap16 plications or supplements within the mean17 ing of part 2; 

18 ‘‘(ii) review times for premarket appli19 cations, premarket reports, premarket noti20 fication submissions, or supplements within 

21 the meaning of part 3; or 

22 ‘‘(iii) review times for animal drug ap23 plications or supplements within the mean24 ing of part 4. 
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1 ‘‘(B) The Secretary may not otherwise ne2 gotiate understandings with such persons on 

3 particular uses of the fees. 

4 ‘‘(2) Notwithstanding such parts, the following 

5 applies on and after October 1, 2005: 

6 ‘‘(A) Any such agreement or under7 standing that was in effect on the day before 

8 the date of the Food and Drug Administration 

9 Improvement Act of 2005 is terminated, includ10 ing agreements or understandings pursuant to 

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

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

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

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

15 1361). 

16 ‘‘(B) The Secretary is relieved of responsi17 bility for meeting any particular goals con18 cerning such review times that were established 

19 in such letters. 

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

21 may not be construed— 

22 ‘‘(1) as affecting the responsibility of the Sec23 retary to work toward the general goal of admin24 istering this Act efficiently, including the review of 
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1 applications, reports, supplements and other submis2 sions referred to in subsection (a)(1)(A); or 

3 ‘‘(2) as terminating requirements for the collec4 tion of fees under part 2, part 3, and part 4.’’. 

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

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

7 (a) of this section, applies with respect to fiscal year 2006 

8 and subsequent fiscal years. 

9 SEC. 3. ESTABLISHMENT OF CENTER FOR POSTMARKET 

10 DRUG SAFETY AND EFFECTIVENESS. 

11 (a) IN GENERAL.—Chapter V of the the Federal 

12 Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) 

13 is amended by inserting after section 505B the following 

14 sections: 

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

16 EFFECTIVENESS. 

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

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

19 Administration Improvement Act of 2005, the Secretary 

20 shall establish within the Food and Drug Administration 

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

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

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

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

25 Commissioner of Food and Drugs under section 
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1 903(d)(2)). The Center shall be established as a separate 

2 center at the organizational level immediately below the 

3 Office of the Commissioner. The Director of the Center 

4 shall report directly to the Commissioner. 

5 ‘‘(b) DUTIES.— 

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

7 shall have the principal responsibility within the 

8 Food and Drug Administration, below the Office of 

9 the Commissioner, for assisting the Commissioner in 

10 regulating approved drugs, other than with respect 

11 to section 501. Such assistance includes assistance 

12 with the following: 

13 ‘‘(A) Administering enforcement authori14 ties under chapter III, including civil penalties 

15 under section 303(f). 

16 ‘‘(B) Administering section 502. 

17 ‘‘(C) Administering requirements for stud18 ies that were required as conditions for the ap19 proval of applications under section 505 (which 

20 studies are conducted after such approval). 

21 ‘‘(D) Administering authorities under sec22 tions 505D and 505E. 

23 ‘‘(E) Monitoring approved drugs to deter24 mine whether there are any issues regarding 

25 safety and effectiveness. 
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1 ‘‘(F) With respect to issues identified 

2 under subparagraph (E), taking action under 

3 the provisions referred to in subparagraphs (A) 

4 through (D), including as appropriate the fol5 lowing: 

6 ‘‘(i) Establishing requirements for ad7 vertising under section 502(n). 

8 ‘‘(ii) Establishing requirements for 

9 modifications in labeling under section 

10 502(x), including the specification of a 

11 date by which the modifications are re12 quired to be made. 

13 ‘‘(iii) Withdrawing the approval of 

14 drugs under section 505(e). 

15 ‘‘(iv) Requiring reports under section 

16 505(k) on clinical experience with approved 

17 drugs, including reports on the number of 

18 individuals using the drugs as indicated by 

19 sales of the drugs at retail and reports on 

20 information possessed by manufacturers on 

21 usage of the drugs. 

22 ‘‘(v) Requiring notifications under sec23 tion 505D(a)(1) to eliminate unreasonable 

24 risks of substantial harm to the public 

25 health. 
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1 ‘‘(vi) Establishing restrictions under 

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

3 of approved drugs, including requirements 

4 for— 

5 ‘‘(I) the specific manner of ob6 taining the informed consent of pa7 tients to undergo treatment with the 

8 drugs; 

9 ‘‘(II) providing education to phy10 sicians; 

11 ‘‘(III) providing education to pa12 tients; and 

13 ‘‘(IV) the establishment of risk14 management plans by manufacturers. 

15 ‘‘(vii) Requiring the conduct of studies 

16 under section 505E. 

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

18 to the Center all responsibilities for the matters re19 ferred to in paragraph (1) that, on the day before 

20 the date of the enactment of the Food and Drug Ad21 ministration Improvement Act of 2005, were vested 

22 in the Center for Drug Evaluation and Research and 

23 the Center for Biologics Evaluation and Research. 

24 ‘‘(c) INTERACTIONS WITH OTHER CENTERS.— 
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1 ‘‘(1) CONSULTATION.—The Director of the 

2 Center shall carry out this section in consultation 

3 with the Directors of the Centers referred to in sub4 section (b)(2). 

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

6 shall ensure that the Director of the Center has full 

7 access to all information possessed by the Food and 

8 Drug Administration that relates to the safety and 

9 effectiveness of approved drugs, including informa10 tion possessed by the Centers referred to in sub11 section (b)(2). 

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

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

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

15 biologics license under section 351 of the Public Health 

16 Service Act is in effect. 

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

18 section, the Secretary shall make available for a fiscal 

19 year, from the amount appropriated for the Food and 

20 Drug Administration for such year, the following amount, 

21 as applicable to such year: 

22 ‘‘(1) For fiscal year 2006, $100,000,000. 

23 ‘‘(2) For fiscal year 2007, $125,000,000. 

24 ‘‘(3) For fiscal year 2008, $150,000,000. 

25 ‘‘(4) For fiscal year 2009, $175,000,000. 
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1 ‘‘(5) For fiscal year 2010, $200,000,000. 

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

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

4 of the enactment of the Food and Drug Administration 

5 Improvement Act of 2005, the Secretary has with respect 

6 to approved drugs the same authorities as the Secretary 

7 has with respect to devices under the following provisions: 

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

9 eliminate an unreasonable risk of substantial harm 

10 to the public health). 

11 ‘‘(2) Section 520(e)(1)(B) (relating to restric12 tions on sale, distribution, or use). 

13 ‘‘(3) Section 520(h) (relating to making avail14 able to the public summaries of information respect15 ing safety and effectiveness). 

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

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

18 in section 505C(d). 

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

20 DRUGS. 

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

22 that the manufacturer of an approved drug conduct one 

23 or more studies to confirm or refute an empirical or theo24 retical hypothesis of a significant safety issue with the 

25 drug (whether raised with respect to the product directly 
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1 or with respect to the class of the product) that has been 

2 identified pursuant to— 

3 ‘‘(1) the MedWatch postmarket surveillance 

4 system; 

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

6 ‘‘(3) the scientific literature; 

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

8 or devices; 

9 ‘‘(5) an international organization concerned 

10 with the safety or effectiveness of drugs or devices; 

11 or 

12 ‘‘(6) such other sources as the Secretary deter13 mines to be appropriate. 

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

15 study under subsection (a) shall be conducted in accord16 ance with a protocol approved by the Secretary. In requir17 ing such a study, the Secretary shall specify a timeframe 

18 for completing the study. 

19 ‘‘(c) PUBLIC DISCLOSURE.— 

20 ‘‘(1) INTERNET SITE.—Notwithstanding 506B, 

21 the Secretary shall maintain on the Internet site of 

22 the Food and Drug Administration a database that 

23 provides information on each study required under 

24 subsection (a), including a description of and the 

25 reason for the study, the required completion date, 
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1 and whether the study has been completed. The Sec2 retary shall update the database not less frequently 

3 than once each quarter. 

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

5 days after first establishing the databank under 

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

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

8 Federal Register the same information as is included 

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

10 Thereafter, the Secretary shall publish in the Fed11 eral Register, not less frequently than once each 

12 quarter, updates that reflect the updates made 

13 under paragraph (1). 

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

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

16 in section 505C(d).’’. 

17 (b) CERTAIN STUDIES.— 

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

19 505E(c) of the Federal Food, Drug, and Cosmetic 

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

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

22 study to which such section applies. 

23 (2) RELEVANT STUDIES.—For purposes of 

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

25 is a study that— 
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1 (A) relates to the safety or effectiveness of 

2 a drug; 

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

4 enactment of this Act; and 

5 (C) was conducted pursuant to an agree6 ment that, or or after January 1, 2003, was en7 tered into with the Secretary of Health and 

8 Human Services, acting through the Commis9 sioner of Food and Drugs. 

10 SEC. 4. ORDER REGARDING POSTMARKET LABELING. 

11 Section 502 of the the Federal Food, Drug, and Cos12 metic Act (21 U.S.C. 352) is amended by adding at the 

13 end the following: 

14 ‘‘(x) If it is a drug and the Secretary deter15 mines that its labeling fails to provide information, 

16 including specific wording, required by the Secretary 

17 by order on the basis that the information is nec18 essary to ensure its safe and effective use.’’. 

19 SEC. 5. ADDITIONAL ENFORCEMENT PROVISIONS. 

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

21 the Federal Food, Drug, and Cosmetic Act, as amended 

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

23 the following: 
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1 ‘‘(y) If it is a drug with respect to which there is 

2 a failure to comply with any requirement under section 

3 505D or 505E.’’. 

4 (b) CIVIL PENALTIES FOR VIOLATIONS OF REQUIRE5 MENTS RELATING TO DRUGS.—Section 303(f) of the the 

6 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333(f)) 

7 is amended— 

8 (1) by redesignating paragraphs (3) through 

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

10 (2) by inserting after paragraph (2) the fol11 lowing paragraph: 

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

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

14 United States for a civil penalty in an amount not 

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

16 not to exceed $50,000,000 for all such violations ad17 judicated in a single proceeding.’’; 

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

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

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

21 (3)’’; and 

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

23 striking ‘‘paragraph (3)(A)’’ and inserting ‘‘para24 graph (4)(A)’’; and 
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1 (5) in paragraph (6) (as so redesignated), by 

2 striking ‘‘paragraph (4)’’ each place such term ap3 pears and inserting ‘‘paragraph (5)’’. 

4 SEC. 6. PREEMPTION. 

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

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

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

8 Health Service Act (or regulations or orders under such 

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

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

11 as the ‘‘Secretary’’) shall follow, without change, the inter12 pretation that was followed by the Food and Drug Admin13 istration in 1999, including the interpretation that such 

14 Administration ‘‘does not believe that the evolution of 

15 state tort law will cause the development of standards that 

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

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

18 not intended to preclude the States from imposing addi19 tional requirements (63 FR 66384). 

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

21 actions regarding product liability that are brought in 

22 State courts against manufacturers of drugs or devices, 

23 policies of the Secretary required under subsection (a) in24 clude the policy that the Secretary cease intervening in 
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1 such actions to argue any interpretation contrary to such 

2 subsection. 

3 SEC. 7. ADDITIONAL PROVISIONS. 

4 (a) REQUIREMENTS REGARDING MEMBERSHIP OF

5 ADVISORY COMMITTEES.—Subchapter A of chapter VII of 

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

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

8 section: 

9 ‘‘SEC. 712. REQUIREMENTS REGARDING MEMBERSHIP OF 

10 ADVISORY COMMITTEES. 

11 ‘‘(a) IN GENERAL.—Notwithstanding any other pro12 vision of law, the Secretary shall comply with the following 

13 with respect to any meeting of an advisory committee con14 vened by the Secretary under this Act: 

15 ‘‘(1) Not later than 30 days before such meet16 ing, the Secretary shall post on the Internet site of 

17 the Food and Drug Administration the agenda for 

18 the meeting and the tentative list of all proposed ad19 visory committee members, together with a short bi20 ography of each such prospective member. 

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

22 Secretary shall provide the public not fewer than 20 

23 days to submit to the Secretary comments on the 

24 proposed membership of the advisory committee. 
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1 ‘‘(3) The Secretary shall consider the public 

2 comments to determine whether any adjustment to 

3 the roster of the advisory committee is necessary to 

4 make the committee fairly balanced. 

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

6 of the meeting, the Secretary shall post on such 

7 Internet site the final membership of the advisory 

8 committee. 

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

10 any other provision of law, a member of an advisory com11 mittee under this Act may not, with respect to service on 

12 such committee, be granted an exemption under section 

13 208(b) of title 18, United States Code (relating to per14 sonal financial interests). 

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

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

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

18 Federal Advisory Committee Act. 

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

20 meaning as applies to such term under section 

21 5(b)(2) of the Federal Advisory Committee Act.’’. 

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

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

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

25 following section: 
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1 ‘‘SEC. 910. REQUIREMENT REGARDING INFORMED CON2 SENT FOR CERTAIN TREATMENTS. 

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

4 not included in the approved labeling for the drug under 

5 section 505 or under section 351 of the Public Health 

6 Service Act, the Secretary shall promulgate regulations re7 quiring that, before prescribing the drug— 

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

9 use for which the physician intends to prescribe the 

10 drug has not been approved by the Food and Drug 

11 Administration; and 

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

13 acknowledgment of such fact and the consent of the 

14 patient to use the drug for such use notwithstanding 

15 such fact.’’. 

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