[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3696 Introduced in House (IH)]







109th CONGRESS
  1st Session
                                H. R. 3696

  To amend the Federal Food, Drug, and Cosmetic Act to require prior 
  approval by the Food and Drug Administration of advertisements for 
   prescription drugs and restricted medical devices, and for other 
                               purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                           September 8, 2005

Mr. Brown of Ohio 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 require prior 
  approval by the Food and Drug Administration of advertisements for 
   prescription drugs and restricted medical devices, 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 ``Medical Advertising Reform Act''.

        TITLE I--LABELING AND ADVERTISING FOR PRESCRIPTION DRUGS

SEC. 101. ADVERTISING FOR PRESCRIPTION DRUGS.

    (a) Advertisements Intended for Consumers; Prior Approval.--Section 
502(n) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352(n)) 
is amended by striking ``except that (A)'' and all that follows through 
``and (B)'' and inserting the following: ``provided that (A)(i) in the 
case of an advertisement intended for consumers of a prescription drug, 
such regulations shall require prior approval by the Secretary of the 
content of the advertisement, which approval or denial shall be issued 
not later than 30 days after the content is submitted to the Secretary, 
and (ii) in the case of an advertisement not so intended, such 
regulations may not, except in extraordinary circumstances, require 
prior approval by the Secretary of the content of the advertisement, 
and (B)''.
    (b) Two-Year Prohibition After Approval of Drug.--
            (1) In general.--Section 505(c) of the Federal Food, Drug, 
        and Cosmetic Act (21 U.S.C. 355(c)) is amended by adding at the 
        end the following paragraph:
    ``(5)(A) In the case of a prescription drug, the Secretary shall 
require as a condition of the approval of an application under 
subsection (b) that the applicant ensure that no advertisement for the 
drug is issued or caused to be issued during the two-year period 
beginning on the date on which the application is approved.
    ``(B) The Secretary, after notice and opportunity for a hearing, 
may extend the two-year period under subparagraph (A) if the Secretary 
determines that such extension is necessary to protect the public 
health.''.
            (2) Enforcement.--Section 502 of 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 prescription drug with respect to which there is a 
failure to comply with a requirement under section 505(c)(5).''.
    (c) Rule of Construction.--The amendments made by subsections (a) 
and (b) may not be construed as affecting the authority of the 
Secretary of Health and Human Services under section 319 of the Public 
Health Service Act (relating to actions to respond to public health 
emergencies).

SEC. 102. LABELING AND ADVERTISING FOR PRESCRIPTION DRUGS; REPORT TO 
              CONGRESS REGARDING COMPARATIVE EFFECTIVENESS AND COST-
              EFFECTIVENESS.

    Not later than one year after the date of the enactment of this 
Act, the Secretary of Health and Human Services, acting through the 
Commissioner of Food and Drugs, shall submit to the Committee on Energy 
and Commerce in the House of Representatives, and the Committee on 
Health, Education, Labor, and Pensions in the Senate, a report 
providing a proposal for the inclusion in the labeling and 
advertisements for each prescription drug of information concerning the 
comparative effectiveness and comparative cost-effectiveness of the 
drug in relation to other prescription drugs that are in the same class 
of drugs. Such report shall include a description of the amendments to 
the Federal Food, Drug, and Cosmetic Act that would be necessary to 
enact such proposal.

SEC. 103. FUNDING FOR DIVISION OF DRUG MARKETING, ADVERTISING, AND 
              COMMUNICATIONS.

    For carrying out the responsibilities of the Division of Drug 
Marketing, Advertising, and Communications (within the Office of 
Medical Policy, Center for Drug Evaluation and Research, Food and Drug 
Administration), there are authorized to be appropriated $25,000,000 
for fiscal year 2007, and such sums as may be necessary for each 
subsequent fiscal year.

          TITLE II--ADVERTISING FOR RESTRICTED MEDICAL DEVICES

SEC. 201. ADVERTISING FOR RESTRICTED DEVICES.

    (a) Advertisements Intended for Consumers; Prior Approval.--Section 
502(r) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352(r)) 
is amended--
            (1) by inserting after the first period the following: ``In 
        the case of an advertisement intended for consumers of a 
        restricted device, regulations under this paragraph shall 
        require prior approval by the Secretary of the content of the 
        advertisement, which approval or denial shall be issued not 
        later than 30 days after the content is submitted to the 
        Secretary.''; and
            (2) by striking ``Except in extraordinary circumstances'' 
        and all that follows through ``prior approval'' and inserting 
        the following: ``In the case of an advertisement not so 
        intended, such regulations may not, except in extraordinary 
        circumstances, require prior approval''.
    (b) Study by Government Accountability Office; Report to 
Congressional Committees.--
            (1) In general.--The Comptroller General of the United 
        States shall conduct a study on the impact of consumer-directed 
        advertising on restricted device utilization and spending. Such 
        study shall consider, for the period January 1, 2001, through 
        December 31, 2005--
                    (A) the growth in retail sales of the 25 restricted 
                devices most heavily advertised (as measured by the 
                volume of advertisements aired or published) relative 
                to the sales of other restricted devices;
                    (B) annual retail price increases of the 25 most 
                heavily advertised devices compared to those of other 
                devices; and
                    (C) such other information as the Comptroller 
                General determines is useful in assessing the impact of 
                advertising on the national health care consumption and 
                spending.
            (2) Evaluation of regulatory controls and sufficiency of 
        resources.--
                    (A) In general.--In conducting the study under 
                paragraph (1), the Comptroller General shall, in 
                addition to considerations under such paragraph, 
                evaluate whether--
                            (i) current regulatory controls are 
                        designed and implemented so as to effectively 
                        ensure that consumer-directed device 
                        advertising provides complete and accurate 
                        information concerning the safety and 
                        effectiveness considerations associated with 
                        advertised devices; and
                            (ii) the Food and Drug Administration 
                        devotes sufficient resources to the tasks of 
                        monitoring and enforcing such controls.
                    (B) Recommendations for congress.--If the 
                Comptroller General concludes that the design or 
                implementation of current regulatory controls is 
                ineffective within the meaning of subparagraph (A)(i), 
                or that the resources allocated for their 
                implementation are insufficient within the meaning of 
                subparagraph (A)(ii), the Comptroller General shall 
                develop recommendations for the Congress for 
                remediation of the deficiencies.
            (3) Definitions.--For purposes of this subsection, the 
        terms ``device'' and ``restricted device'' have the meanings 
        that apply for purposes of the Federal Food, Drug, and Cosmetic 
        Act.
            (4) Report.--Not later than July 1, 2006, the Comptroller 
        General shall submit to the Committee on Energy and Commerce in 
        the House of Representatives, and the Committee on Finance in 
        the Senate, a report providing the findings of the study under 
        paragraph (1), including (as applicable) recommendations under 
        paragraph (2)(B).

SEC. 202. FUNDING FOR OFFICE OF COMPLIANCE.

    For carrying out the responsibilities of the Office of Compliance 
(within the Center for Devices and Radiological Health, Food and Drug 
Administration), there are authorized to be appropriated $5,000,000 for 
each of the fiscal years 2007 through 2009, and such sums as may be 
necessary for each subsequent fiscal year.

  TITLE III--AVAILABILITY TO PUBLIC OF OBJECTIVE INFORMATION ON DRUGS

SEC. 301. AVAILABILITY OF INFORMATION.

    (a) In General.--The Secretary of Health and Human Services shall 
provide for the availability to the public of objective information on 
health conditions and treatments through--
            (1) maintaining a toll-free telephone number to provide 
        such information;
            (2) carrying out a public information campaign to make the 
        public aware that such information is available from the 
        Department of Health and Human Services through such telephone 
        number and through the Internet site www.healthfinder.gov (or 
        successor site); and
            (3) using the telephone number under paragraph (1), and the 
        Internet site of the Food and Drug Administration, to make the 
        public aware of the Internet site referred to in paragraph (2).
    (b) Authorization of Appropriations for Public Information 
Campaign.--For the purpose of carrying out subsection (a)(2), there are 
authorized to be appropriated such sums as may be necessary for each of 
the fiscal years 2007 through 2009.
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