[Congressional Bills 111th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4816 Introduced in House (IH)]

111th CONGRESS
  2d Session
                                H. R. 4816

 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

                             March 10, 2010

 Mr. Hinchey 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 2010''.

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 6--MODIFICATIONS REGARDING USER-FEE PROGRAMS

``SEC. 743. DEPOSIT OF FEES IN GENERAL FUND OF TREASURY; DIRECT 
              SPENDING.

    ``(a) Deposit in General Fund.--Notwithstanding any other provision 
of this Act related to the collection of fees related to drugs, 
devices, animal drugs, or generic animal drugs, all such fees collected 
under this Act shall be deposited in the general fund of the Treasury.
    ``(b) Direct Spending.--
            ``(1) In general.--Notwithstanding any other provision of 
        this Act related to the collection of such fees, amounts are 
        available to the Secretary for obligation in accordance with 
        the following:
                    ``(A) The amount authorized to be appropriated 
                under section 736 for fees related to drugs is, to the 
                extent described in section 736(g)(2)(A)(ii) (as in 
                effect on September 30, 2010), available to the 
                Secretary for obligation solely for the process for the 
                review of human drug applications (within the meaning 
                given to such term in section 735, as in effect on 
                September 30, 2010).
                    ``(B) The amount authorized to be appropriated 
                under section 736A for fees relating to advisory review 
                of prescription-drug television advertising is, to the 
                extent described in section 736A(g)(2)(A)(ii) (as in 
                effect on September 30, 2010), available to the 
                Secretary for obligation solely for the process for the 
                advisory review of prescription drug advertising 
                (within the meaning given to such terms in section 
                736A, as in effect on September 30, 2010).
                    ``(C) The amount authorized to be appropriated 
                under section 736A-1 for fees relating to the 
                regulation of advertisements for drugs and devices is 
                available to the Secretary for obligation solely for 
                such regulation.
                    ``(D) The amount authorized to be appropriated 
                under this Act for fees related to devices is, to the 
                extent described in section 738(h)(2)(A)(ii) (as in 
                effect on September 30, 2010), available to the 
                Secretary for obligation solely for the process for the 
                review of device applications (within the meaning given 
                to such terms in section 737, as in effect on September 
                30, 2010).
                    ``(E) The amount authorized to be appropriated 
                under this Act for fees related to animal drugs is, to 
                the extent described in section 740(g)(2)(A)(ii) (as in 
                effect on September 30, 2010), available to the 
                Secretary for obligation solely for the process for the 
                review of animal drug applications (within the meaning 
                given to such terms in section 739, as in effect on 
                September 30, 2010).
                    ``(F) The amount authorized to be appropriated 
                under this Act for fees related to generic new animal 
                drugs is, to the extent described in section 
                741(g)(2)(A)(ii) (as in effect on September 30, 2010), 
                available to the Secretary for obligation solely for 
                the process for the review of abbreviated applications 
                for generic new animal drugs (within the meanings given 
                to such terms in section 741, as in effect on September 
                30, 2010).
            ``(2) List of mandatory appropriations.--The program of 
        spending established in paragraph (1) shall be considered 
        entitlement authority within the meaning of section 250(c)(17) 
        of the Balanced Budget and Emergency Deficit Control Act of 
        1985.

``SEC. 744. TERMINATION OF AUTHORITY FOR NEGOTIATIONS WITH 
              MANUFACTURERS ON USE OF FEES.

    ``(a) In General.--With respect to persons from whom fees related 
to drugs, devices, animal drugs, or generic animal drugs are collected 
under this Act and notwithstanding any other provision of this Act 
related to the collection of such fees:
            ``(1) On and after the date of the enactment of the Food 
        and Drug Administration Improvement Act of 2010:
                    ``(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 
                        given to such terms in section 735, as in 
                        effect on September 30, 2010);
                            ``(ii) review times for providing advisory 
                        comments on direct-to-consumer television 
                        advertisements (within the meaning given to 
                        such terms in section 736A, as in effect on 
                        September 30, 2010);
                            ``(iii) review times for premarket 
                        applications, premarket reports, premarket 
                        notification submissions, or supplements 
                        (within the meaning given to such terms in 
                        section 737, as in effect on September 30, 
                        2010);
                            ``(iv) review times for animal drug 
                        applications or supplements (within the meaning 
                        given to such terms in section 739, as in 
                        effect on September 30, 2010); or
                            ``(v) review times for abbreviated 
                        applications for a generic new animal drug or 
                        supplements thereto (within the meaning given 
                        to such terms in section 741, as in effect on 
                        September 30, 2010).
                    ``(B) The Secretary may not otherwise negotiate 
                understandings with such persons on particular uses of 
                the fees.
            ``(2) On and after October 1, 2010:
                    ``(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 2010 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), section 2(3) of 
                Public Law 108-130 (117 Stat. 1361), and section 101(c) 
                of Public Law 110-85 (121 Stat. 823).
                    ``(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 any other provision of this Act.''.
    (b) Applicability.--Section 743 of the Federal Food, Drug, and 
Cosmetic Act, as added by subsection (a) of this section, applies with 
respect to fiscal year 2011 and subsequent fiscal years.
    (c) Management Strategy To Ensure the Timely Review of 
Applications.--
            (1) In general.--The Secretary of Health and Human Services 
        (in this subsection referred to as the ``Secretary'') shall 
        submit to the Committees on Appropriations and Energy and 
        Commerce of the House of Representatives and the Committees on 
        Appropriations and Health, Education, Labor, and Pensions of 
        the Senate a comprehensive review of the drug and device 
        application and amendment process to identify ways to increase 
        efficiency, reduce paperwork, speed analysis, and promote the 
        quickest possible decision process designed to ensure the entry 
        of safe, effective drugs and devices into the marketplace.
            (2) Considerations.--In carrying out the review under 
        paragraph (1), the Secretary shall consider a time-and-motion 
        study to identify best practices in processing applications and 
        ensure the consideration of safety issues.
            (3) Staff-to-application ratio.--In carrying out the review 
        under paragraph (1), not later than 180 days after the date of 
        enactment of this Act, the Secretary shall submit to the 
        committees referred to in such paragraph recommendations on an 
        ideal staff-to-application ratio to address safety issues 
        without slowing the decision process.

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

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

``SEC. 505E. CENTER FOR POSTMARKET DRUG, DEVICE, AND BIOLOGIC 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 2010, 
the Secretary shall establish within the Food and Drug Administration a 
center to be known as the Center for Postmarket Drug, Device, and 
Biologic Safety and Effectiveness (referred to in this section as the 
`Center'), which shall be headed by a director appointed by the 
Commissioner of Food and Drugs in consultation with the Secretary 
(without regard to the delegation to the Commissioner under section 
1003(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.--Subject to paragraph (2), the Director 
        of the Center shall have the principal responsibility within 
        the Food and Drug Administration, below the Office of the 
        Commissioner of Food and Drugs, for assisting the Commissioner 
        in regulating approved drugs and devices. Such assistance 
        includes the following:
                    ``(A) Monitoring approved drugs to determine 
                whether there are any issues regarding safety or 
                effectiveness.
                    ``(B) Administering section 502 (relating to 
                misbranding).
                    ``(C) Establishing and administering requirements 
                for advertising under section 502(n) or 503(b).
                    ``(D) Administering requirements for studies and 
                clinical trials that were required as conditions for 
                the approval of applications under section 505.
                    ``(E) Withdrawing the approval of drugs under 
                section 505(e).
                    ``(F) Administering section 505(l)(2) (relating to 
                action packages for approval).
                    ``(G) Establishing and administering requirements 
                for modifications in labeling under section 505(o)(4).
                    ``(H) Administering authorities under sections 
                505(p) and 505-1 (relating to risk evaluation and 
                mitigation strategies).
                    ``(I) Administering section 505(r) (relating to 
                postmarket drug safety information for patients and 
                providers).
            ``(2) Exclusion.--The responsibility vested in the Director 
        of the Center does not include review of any request for 
        approval, licensure, or clearance of a new active ingredient, 
        new indication, new dosage form, new dosing regimen, new route 
        of administration, or any other new characteristic with respect 
        to a previously approved, licensed, or cleared drug, biological 
        product, or device.
            ``(3) Transfers.--Not later than 1 year after the date of 
        the enactment of this section, 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 such 
        transfer, were vested in the Center for Drug Evaluation and 
        Research, the Center for Biologics Evaluation and Research, or 
        the Center for Devices and Radiological Health Organization.
    ``(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)(3).
            ``(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 and 
        devices, including information possessed by the Centers 
        referred to in subsection (b)(3).
    ``(d) Definition.--For purposes of this section, the term `approved 
drugs and devices' includes a drug for which an approved application 
under section 505 of this Act is in effect, a biological product for 
which a biologics license under section 351 of the Public Health 
Service Act is in effect, or a device for which a clearance or approved 
application under section 510(k) or 515 of this 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 2011, $150,000,000.
            ``(2) For fiscal year 2012, $175,000,000.
            ``(3) For fiscal year 2013, $200,000,000.
            ``(4) For fiscal year 2014, $225,000,000.
            ``(5) For fiscal year 2015, $250,000,000.''.

SEC. 4. STATEMENT FOR INCLUSION IN DIRECT-TO-CONSUMER ADVERTISEMENTS OF 
              DRUGS.

    (a) In General.--Paragraph (3) of section 502(n) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 352(n)) is amended by striking 
``published direct-to-consumer advertisements'' and inserting 
``published or televised direct-to-consumer advertisements''.
    (b) Effective Date.--The requirements of section 502(n)(3) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352(n)(3)) applicable 
to televised direct-to-consumer advertisements, as added by subsection 
(a), take effect on the date that is 180 days after the date of the 
enactment of this Act.
    (c) Regulations.--Not later than the date that is 180 days after 
the date of the enactment of this Act, the Secretary of Health and 
Human Services shall promulgate final regulations to implement such 
requirements.

SEC. 5. LIABILITY UNDER STATE AND LOCAL REQUIREMENTS RESPECTING 
              DEVICES.

    (a) Amendment.--Section 521 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360k) is amended by adding at the end the following:
    ``(c) No Effect on Liability Under State Law.--Nothing in this 
section shall be construed to modify or otherwise affect any action for 
damages or the liability of any person under the law of any State.''.
    (b) Effective Date; Applicability.--The amendment made by 
subsection (a) shall--
            (1) take effect as if included in the enactment of the 
        Medical Device Amendments of 1976 (Public Law 94-295); and
            (2) apply to any civil action pending or filed on or after 
        the date of enactment of this Act.

SEC. 6. CLARITY IN DRUG LABELING.

    (a) In General.--Not later than 1 year after the date of the 
enactment of this Act, the Secretary of Health and Human Services (in 
this section referred to as the ``Secretary''), acting through the 
Commissioner of Food and Drugs, shall--
            (1) complete a review of the Food and Drug Administration's 
        regulations and guidance pertaining to the labeling of drugs 
        and biological products; and
            (2) revise such regulations and guidance as appropriate to 
        improve the clarity and readability of such labeling.
    (b) Applicability.--
            (1) New products.--With respect to the labeling of any drug 
        or biological product that is approved or licensed under 
        section 505 of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 355) or section 351 of the Public Health Service Act (42 
        U.S.C. 262) on or after the day that is 1 year after the date 
        of the enactment of this Act, the revised regulations and 
        guidance under subsection (a)(2) shall apply as of the date of 
        such approval or licensure.
            (2) Existing products.--With respect to any drug or 
        biological product that was so approved or licensed before such 
        day, the revised regulations and guidance under subsection 
        (a)(2) shall apply as soon as the Secretary determines 
        practicable.

SEC. 7. DISCLOSURE OF CLINICAL TRIAL ADVERSE EVENTS ON FDA WEB SITE.

    (a) In General.--The Secretary of Health and Human Services, acting 
through the Commissioner of Food and Drugs, shall make all clinical 
trial adverse events included in the registry and results data bank of 
the National Institutes of Health publicly available on the Web site of 
the Food and Drug Administration.
    (b) Definition.--In this section, the term ``registry and results 
data bank'' has the meaning given to such term in section 
402(j)(3)(B)(i) of the Public Health Service Act (42 U.S.C. 
282(j)(3)(B)(i)).

SEC. 8. PROHIBITION AGAINST PARTICIPATION BY ADVISORY COMMITTEE MEMBERS 
              WITH CONFLICTS OF INTEREST.

    Section 712 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379d-1) is amended--
            (1) in paragraph (2) of subsection (b), by striking ``, so 
        as to reduce'' and all that follows through the end of the 
        paragraph and inserting a period;
            (2) in subsection (c)--
                    (A) by amending the subsection heading to read as 
                follows: ``Prohibition; Inapplicability of Waivers'';
                    (B) in subparagraph (A) of paragraph (2), by 
                striking ``Except as provided under subparagraph (B), a 
                member'' and inserting ``A member'';
                    (C) by striking subparagraphs (B) and (C) of 
                paragraph (2) and inserting the following:
                    ``(B) Inapplicability of waivers.--A member of an 
                advisory committee under this Act may not, with respect 
                to service on such committee, be granted a written 
                determination as referred to in section 208(b)(1) of 
                title 18, United States Code, or a written 
                certification as referred to in section 208(b)(3) of 
                title 18, United States Code.''; and
                    (D) by striking paragraph (3);
            (3) in subsection (e)--
                    (A) in paragraph (1), by inserting ``and'' at the 
                end;
                    (B) by striking paragraphs (2) and (3); and
                    (C) by redesignating paragraph (4) as paragraph 
                (2); and
            (4) by striking subsection (f).

SEC. 9. FEES RELATING TO ADVERTISEMENTS FOR DRUGS AND DEVICES.

    Part 2 of subchapter C of chapter VII (21 U.S.C. 379g et seq.) is 
amended by inserting after section 736A the following:

``SEC. 736A-1. FEES RELATING TO ADVERTISEMENTS FOR DRUGS AND DEVICES.

    ``(a) In General.--Beginning with respect to fiscal year 2011, each 
person intending to publish or disseminate an advertisement for a drug 
or device during a fiscal year shall, prior to the advertisement's 
initial publication or dissemination during such fiscal year, pay a fee 
to the Secretary in the amount established under subsection (b).
    ``(b) Fee Amounts.--
            ``(1) Total revenue amounts.--For each of fiscal years 2011 
        through 2015, the Secretary shall establish fees under 
        subsection (a) to generate a total revenue amount equal to 
        $4,000,000, except that such amount shall be adjusted for each 
        of fiscal years 2012 through 2015 to reflect inflation.
            ``(2) Fee setting.--The Secretary shall--
                    ``(A) set the amount of fees to be assessed and 
                collected under this section before the start of the 
                relevant fiscal year;
                    ``(B) make such fees payable with respect to each 
                distinct advertisement for a drug or device to be 
                published or disseminated during the fiscal year; and
                    ``(C) set the amount of such fees without regard to 
                the number of times on which the advertisement is so 
                published or disseminated.
            ``(3) Limit.--Notwithstanding paragraph (1), the fees under 
        this section shall be retained in each fiscal year in an amount 
        not to exceed the total costs for such fiscal year for the 
        regulation of advertisements for drugs and devices.
    ``(c) Definition.--In this section:
            ``(1) The term `advertisement' shall be defined by the 
        Secretary.
            ``(2) The term `regulation of advertisements for drugs and 
        devices'--
                    ``(A) means any regulation of advertisements for 
                drugs and devices by the Food and Drug Administration 
                under this Act; and
                    ``(B) notwithstanding subparagraph (A), excludes 
                activities for which fees are assessed and collected 
                under section 736A (relating to the process for the 
                advisory review of prescription drug advertising).
    ``(d) Collections and Appropriation Acts.--
            ``(1) In general.--The fees authorized by this section--
                    ``(A) notwithstanding subsection (b)(1), shall be 
                retained in each fiscal year in an amount not to exceed 
                the amount specified in appropriation Acts, or 
                otherwise made available for obligation, for such 
                fiscal year; and
                    ``(B) shall only be collected and available to 
                defray the costs for such fiscal year for the 
                regulation of advertisements of drugs and devices.
            ``(2) Authorization of appropriations.--For each of fiscal 
        years 2011 through 2015, there is authorized to be appropriated 
        for the assessment, collection, and use of fees under this 
        section an amount equal to the total revenue amount determined 
        under subsection (b) for the fiscal year.''.

SEC. 10. CERTAIN USES OF APPROVED DRUGS.

    Chapter X of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
391 et seq.) is amended by adding at the end the following:

``SEC. 1011. 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.''.
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