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[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2090 Introduced in House (IH)]

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.

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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Food and Drug Administration 
Improvement Act of 2005''.

SEC. 2. FEES PAID BY MANUFACTURERS TO FOOD AND DRUG ADMINISTRATION; 
              DEPOSIT IN GENERAL FUND OF TREASURY; DIRECT SPENDING.

    (a) In General.--Subchapter C of chapter VII of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379f et seq.) is amended by adding at 
the end the following part:

          ``PART 5--MODIFICATIONS REGARDING USER-FEE PROGRAMS

``SEC. 740A. DEPOSIT OF FEES IN GENERAL FUND OF TREASURY; DIRECT 
              SPENDING.

    ``(a) Deposit in General Fund.--Notwithstanding part 2, part 3, and 
part 4, all fees collected under such parts shall be deposited in the 
general fund of the Treasury.
    ``(b) Direct Spending.--
            ``(1) In general.--Notwithstanding part 2, part 3, and part 
        4, amounts are available to the Secretary for obligation in 
        accordance with the following:
                    ``(A) The amount specified in section 736(g)(3) for 
                a fiscal year is, to the extent described in section 
                736(g)(2)(A)(ii), available to the Secretary for 
                obligation solely for the process for the review of 
                human drug applications (as defined in section 735).
                    ``(B) The amount specified in section 738(h)(3) for 
                a fiscal year is, to the extent described in section 
                738(h)(2)(A)(ii), available to the Secretary for 
                obligation solely for the process for the review of 
                device applications (as defined in section 737).
                    ``(C) The amount specified in section 740(g)(3) for 
                a fiscal year is, to the extent described in section 
                740(g)(2)(A)(ii), available to the Secretary for 
                obligation solely for the process for the review of 
                animal drug applications (as defined in section 739).
            ``(2) List of mandatory appropriations.--The program of 
        spending established in paragraph (1) shall be considered 
        entitlement authority within the meaning of section 250(17) of 
        the Balanced Budget and Emergency Deficit Control Act of 1985.

``SEC. 740B. TERMINATION OF AUTHORITY FOR NEGOTIATIONS WITH 
              MANUFACTURERS ON USE OF FEES.

    ``(a) In General.--With respect to persons from whom fees are 
collected under part 2, part 3, or part 4:
            ``(1) Notwithstanding such parts, the following applies on 
        and after the date of the enactment of the Food and Drug 
        Administration Improvement Act of 2005:
                    ``(A) The Secretary may not enter into agreements 
                with such persons on particular uses of the fees, 
                including agreements on priorities, performance goals, 
                or other commitments relating to--
                            ``(i) review times for human drug 
                        applications or supplements within the meaning 
                        of part 2;
                            ``(ii) review times for premarket 
                        applications, premarket reports, premarket 
                        notification submissions, or supplements within 
                        the meaning of part 3; or
                            ``(iii) review times for animal drug 
                        applications or supplements within the meaning 
                        of part 4.
                    ``(B) The Secretary may not otherwise negotiate 
                understandings with such persons on particular uses of 
                the fees.
            ``(2) Notwithstanding such parts, the following applies on 
        and after October 1, 2005:
                    ``(A) Any such agreement or understanding that was 
                in effect on the day before the date of the Food and 
                Drug Administration Improvement Act of 2005 is 
                terminated, including agreements or understandings 
                pursuant to letters referred to in section 502(4) of 
                Public Law 107-188 (116 Stat. 688), section 101(3) of 
                Public Law 107-250 (116 Stat. 1589), and section 2(3) 
                of Public Law 108-130 (117 Stat. 1361).
                    ``(B) The Secretary is relieved of responsibility 
                for meeting any particular goals concerning such review 
                times that were established in such letters.
    ``(b) Rules of Construction.--Subsection (a) may not be construed--
            ``(1) as affecting the responsibility of the Secretary to 
        work toward the general goal of administering this Act 
        efficiently, including the review of applications, reports, 
        supplements and other submissions referred to in subsection 
        (a)(1)(A); or
            ``(2) as terminating requirements for the collection of 
        fees under part 2, part 3, and part 4.''.
    (b) Applicability.--Section 740A of the Federal Food, Drug, and 
Cosmetic Act, as added by subsection (a) of this section, applies with 
respect to fiscal year 2006 and subsequent fiscal years.

SEC. 3. ESTABLISHMENT OF CENTER FOR POSTMARKET DRUG SAFETY AND 
              EFFECTIVENESS.

    (a) In General.--Chapter V of the the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 351 et seq.) is amended by inserting after 
section 505B the following sections:

``SEC. 505C. CENTER FOR POSTMARKET DRUG SAFETY AND EFFECTIVENESS.

    ``(a) Establishment.--Not later than 180 days after the date of the 
enactment of the Food and Drug Administration Improvement Act of 2005, 
the Secretary shall establish within the Food and Drug Administration a 
center to be known as the Center for Postmarket Drug Safety and 
Effectiveness (referred to in this section as the `Center'), which 
shall be headed by a director appointed by the Secretary (without 
regard to the delegation to the Commissioner of Food and Drugs under 
section 903(d)(2)). The Center shall be established as a separate 
center at the organizational level immediately below the Office of the 
Commissioner. The Director of the Center shall report directly to the 
Commissioner.
    ``(b) Duties.--
            ``(1) In general.--The Director of the Center shall have 
        the principal responsibility within the Food and Drug 
        Administration, below the Office of the Commissioner, for 
        assisting the Commissioner in regulating approved drugs, other 
        than with respect to section 501. Such assistance includes 
        assistance with the following:
                    ``(A) Administering enforcement authorities under 
                chapter III, including civil penalties under section 
                303(f).
                    ``(B) Administering section 502.
                    ``(C) Administering requirements for studies that 
                were required as conditions for the approval of 
                applications under section 505 (which studies are 
                conducted after such approval).
                    ``(D) Administering authorities under sections 505D 
                and 505E.
                    ``(E) Monitoring approved drugs to determine 
                whether there are any issues regarding safety and 
                effectiveness.
                    ``(F) With respect to issues identified under 
                subparagraph (E), taking action under the provisions 
                referred to in subparagraphs (A) through (D), including 
                as appropriate the following:
                            ``(i) Establishing requirements for 
                        advertising under section 502(n).
                            ``(ii) Establishing requirements for 
                        modifications in labeling under section 502(x), 
                        including the specification of a date by which 
                        the modifications are required to be made.
                            ``(iii) Withdrawing the approval of drugs 
                        under section 505(e).
                            ``(iv) Requiring reports under section 
                        505(k) on clinical experience with approved 
                        drugs, including reports on the number of 
                        individuals using the drugs as indicated by 
                        sales of the drugs at retail and reports on 
                        information possessed by manufacturers on usage 
                        of the drugs.
                            ``(v) Requiring notifications under section 
                        505D(a)(1) to eliminate unreasonable risks of 
                        substantial harm to the public health.
                            ``(vi) Establishing restrictions under 
                        section 505D(a)(2) to ensure the safe use of 
                        approved drugs, including requirements for--
                                    ``(I) the specific manner of 
                                obtaining the informed consent of 
                                patients to undergo treatment with the 
                                drugs;
                                    ``(II) providing education to 
                                physicians;
                                    ``(III) providing education to 
                                patients; and
                                    ``(IV) the establishment of risk-
                                management plans by manufacturers.
                            ``(vii) Requiring the conduct of studies 
                        under section 505E.
            ``(2) Transfers.--The Secretary shall transfer to the 
        Center all responsibilities for the matters referred to in 
        paragraph (1) that, on the day before the date of the enactment 
        of the Food and Drug Administration Improvement Act of 2005, 
        were vested in the Center for Drug Evaluation and Research and 
        the Center for Biologics Evaluation and Research.
    ``(c) Interactions With Other Centers.--
            ``(1) Consultation.--The Director of the Center shall carry 
        out this section in consultation with the Directors of the 
        Centers referred to in subsection (b)(2).
            ``(2) Access to information.--The Secretary shall ensure 
        that the Director of the Center has full access to all 
        information possessed by the Food and Drug Administration that 
        relates to the safety and effectiveness of approved drugs, 
        including information possessed by the Centers referred to in 
        subsection (b)(2).
    ``(d) Definition.--For purposes of this section, the term `approved 
drug' means a drug for which an approved application under section 505 
is in effect or for which a biologics license under section 351 of the 
Public Health Service Act is in effect.
    ``(e) Funding.--For the purpose of carrying out this section, the 
Secretary shall make available for a fiscal year, from the amount 
appropriated for the Food and Drug Administration for such year, the 
following amount, as applicable to such year:
            ``(1) For fiscal year 2006, $100,000,000.
            ``(2) For fiscal year 2007, $125,000,000.
            ``(3) For fiscal year 2008, $150,000,000.
            ``(4) For fiscal year 2009, $175,000,000.
            ``(5) For fiscal year 2010, $200,000,000.

``SEC. 505D. CERTAIN POSTMARKET AUTHORITIES.

    ``(a) In General.--Effective on and after the date of the enactment 
of the Food and Drug Administration Improvement Act of 2005, the 
Secretary has with respect to approved drugs the same authorities as 
the Secretary has with respect to devices under the following 
provisions:
            ``(1) Section 518(a) (relating to notifications to 
        eliminate an unreasonable risk of substantial harm to the 
        public health).
            ``(2) Section 520(e)(1)(B) (relating to restrictions on 
        sale, distribution, or use).
            ``(3) Section 520(h) (relating to making available to the 
        public summaries of information respecting safety and 
        effectiveness).
    ``(b) Definition.--For purposes of this section, the term `approved 
drug' has the meaning given such term in section 505C(d).

``SEC. 505E. POSTMARKET STUDIES REGARDING SAFETY OF DRUGS.

    ``(a) Phase 4 Studies.--The Secretary may require that the 
manufacturer of an approved drug conduct one or more studies to confirm 
or refute an empirical or theoretical hypothesis of a significant 
safety issue with the drug (whether raised with respect to the product 
directly or with respect to the class of the product) that has been 
identified pursuant to--
            ``(1) the MedWatch postmarket surveillance system;
            ``(2) a clinical or epidemiological study;
            ``(3) the scientific literature;
            ``(4) a foreign government that regulates drugs or devices;
            ``(5) an international organization concerned with the 
        safety or effectiveness of drugs or devices; or
            ``(6) such other sources as the Secretary determines to be 
        appropriate.
    ``(b) Approval of Protocol; Timeframe.--A study under subsection 
(a) shall be conducted in accordance with a protocol approved by the 
Secretary. In requiring such a study, the Secretary shall specify a 
timeframe for completing the study.
    ``(c) Public Disclosure.--
            ``(1) Internet site.--Notwithstanding 506B, the Secretary 
        shall maintain on the Internet site of the Food and Drug 
        Administration a database that provides information on each 
        study required under subsection (a), including a description of 
        and the reason for the study, the required completion date, and 
        whether the study has been completed. The Secretary shall 
        update the database not less frequently than once each quarter.
            ``(2) Federal register.--Not later than 30 days after first 
        establishing the databank under paragraph (1), the Secretary 
        shall, with respect to studies required under subsection (a), 
        publish in the Federal Register the same information as is 
        included in such database as of the date of such publication. 
        Thereafter, the Secretary shall publish in the Federal 
        Register, not less frequently than once each quarter, updates 
        that reflect the updates made under paragraph (1).
    ``(d) Definition.--For purposes of this section, the term `approved 
drug' has the meaning given such term in section 505C(d).''.
    (b) Certain Studies.--
            (1) In general.--With respect to section 505E(c) of the 
        Federal Food, Drug, and Cosmetic Act (as added by subsection 
        (a) of this section), each study described in paragraph (2) is 
        deemed to be a study to which such section applies.
            (2) Relevant studies.--For purposes of paragraph (1), a 
        study described in this paragraph is a study that--
                    (A) relates to the safety or effectiveness of a 
                drug;
                    (B) was in progress as of the date of the enactment 
                of this Act; and
                    (C) was conducted pursuant to an agreement that, or 
                or after January 1, 2003, was entered into with the 
                Secretary of Health and Human Services, acting through 
                the Commissioner of Food and Drugs.

SEC. 4. ORDER REGARDING POSTMARKET LABELING.

    Section 502 of the the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 352) is amended by adding at the end the following:
            ``(x) If it is a drug and the Secretary determines that its 
        labeling fails to provide information, including specific 
        wording, required by the Secretary by order on the basis that 
        the information is necessary to ensure its safe and effective 
        use.''.

SEC. 5. ADDITIONAL ENFORCEMENT PROVISIONS.

    (a) Postmarket Authorities.--Section 502 of the the Federal Food, 
Drug, and Cosmetic Act, as amended by section 4 of this Act, is amended 
by adding at the end the following:
    ``(y) If it is a drug with respect to which there is a failure to 
comply with any requirement under section 505D or 505E.''.
    (b) Civil Penalties for Violations of Requirements Relating to 
Drugs.--Section 303(f) of the the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 333(f)) is amended--
            (1) by redesignating paragraphs (3) through (5) as 
        paragraphs (4) through (6), respectively;
            (2) by inserting after paragraph (2) the following 
        paragraph:
            ``(3) Any person who violates a requirement of this Act 
        which relates to drugs shall be liable to the United States for 
        a civil penalty in an amount not exceeding $50,000 per day for 
        each such violation, not to exceed $50,000,000 for all such 
        violations adjudicated in a single proceeding.'';
            (3) in paragraph (4) (as so redesignated) by striking 
        ``paragraph (1) or (2)'' each place such term appears and 
        inserting ``paragraph (1), (2), or (3)''; and
            (4) in paragraph (5) (as so redesignated), by striking 
        ``paragraph (3)(A)'' and inserting ``paragraph (4)(A)''; and
            (5) in paragraph (6) (as so redesignated), by striking 
        ``paragraph (4)'' each place such term appears and inserting 
        ``paragraph (5)''.

SEC. 6. PREEMPTION.

    (a) In General.--With respect to the issue of whether a provision 
of chapter V of the Federal Food, Drug, and Cosmetic Act or of section 
351 of the Public Health Service Act (or regulations or orders under 
such a provision) supersedes the law of a State, the Secretary of 
Health and Human Services (referred to in this section as the 
``Secretary'') shall follow, without change, the interpretation that 
was followed by the Food and Drug Administration in 1999, including the 
interpretation that such Administration ``does not believe that the 
evolution of state tort law will cause the development of standards 
that would be at odds with the agency's regulations'' and that such 
regulations ``establish minimal standards'' but are not intended to 
preclude the States from imposing additional requirements (63 FR 
66384).
    (b) Product Liability Cases.--In the case of civil actions 
regarding product liability that are brought in State courts against 
manufacturers of drugs or devices, policies of the Secretary required 
under subsection (a) include the policy that the Secretary cease 
intervening in such actions to argue any interpretation contrary to 
such subsection.

SEC. 7. ADDITIONAL PROVISIONS.

    (a) Requirements Regarding Membership of Advisory Committees.--
Subchapter A of chapter VII of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 371 et seq.) is amended by adding at the end the following 
section:

``SEC. 712. REQUIREMENTS REGARDING MEMBERSHIP OF ADVISORY COMMITTEES.

    ``(a) In General.--Notwithstanding any other provision of law, the 
Secretary shall comply with the following with respect to any meeting 
of an advisory committee convened by the Secretary under this Act:
            ``(1) Not later than 30 days before such meeting, the 
        Secretary shall post on the Internet site of the Food and Drug 
        Administration the agenda for the meeting and the tentative 
        list of all proposed advisory committee members, together with 
        a short biography of each such prospective member.
            ``(2) After compliance with paragraph (1), the Secretary 
        shall provide the public not fewer than 20 days to submit to 
        the Secretary comments on the proposed membership of the 
        advisory committee.
            ``(3) The Secretary shall consider the public comments to 
        determine whether any adjustment to the roster of the advisory 
        committee is necessary to make the committee fairly balanced.
            ``(4) Not later than three days before the start of the 
        meeting, the Secretary shall post on such Internet site the 
        final membership of the advisory committee.
    ``(b) Conflicts of Interest.--Notwithstanding any other provision 
of law, a member of an advisory committee under this Act may not, with 
respect to service on such committee, be granted an exemption under 
section 208(b) of title 18, United States Code (relating to personal 
financial interests).
    ``(c) Definitions.--For purposes of this section:
            ``(1) The term `advisory committee' has the same meaning 
        given such term in section 3(2) of the Federal Advisory 
        Committee Act.
            ``(2) The term `fairly balanced' has the same meaning as 
        applies to such term under section 5(b)(2) of the Federal 
        Advisory Committee Act.''.
    (b) Certain Uses of Approved Drugs.--Chapter IX of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 391 et seq.) is amended by 
adding at the end the following section:

``SEC. 910. REQUIREMENT REGARDING INFORMED CONSENT FOR CERTAIN 
              TREATMENTS.

    ``With respect to the prescribing of a drug for a use not included 
in the approved labeling for the drug under section 505 or under 
section 351 of the Public Health Service Act, the Secretary shall 
promulgate regulations requiring that, before prescribing the drug--
            ``(1) the physician inform the patient that the use for 
        which the physician intends to prescribe the drug has not been 
        approved by the Food and Drug Administration; and
            ``(2) the physician obtain from the patient an 
        acknowledgment of such fact and the consent of the patient to 
        use the drug for such use notwithstanding such fact.''.
                                 <all>
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