[Congressional Bills 111th Congress]
[From the U.S. Government Publishing Office]
[S. 1142 Introduced in Senate (IS)]

111th CONGRESS
  1st Session
                                S. 1142

   To amend the Federal Food, Drug, and Cosmetic Act with respect to 
inclusion of effectiveness information in drug and device labeling and 
                              advertising.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                              May 21, 2009

Mr. Reed (for himself and Ms. Mikulski) introduced the following bill; 
     which was read twice and referred to the Committee on Health, 
                     Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
   To amend the Federal Food, Drug, and Cosmetic Act with respect to 
inclusion of effectiveness information in drug and device labeling and 
                              advertising.

    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 ``Informed Health Care Decision Making 
Act''.

SEC. 2. FINDINGS.

    Congress finds the following:
            (1) National randomized controlled trials have found that 
        replacing the brief summary of drug advertisements with a drug 
        facts box improved consumer knowledge and judgments. In such 
        trials, consumers who were presented with a drug facts box more 
        accurately perceived the side effects and benefits of a drug, 
        and were more than twice as likely to choose the superior drug.
            (2)(A) In 2007, the Institute of Medicine conducted a 
        workshop that highlighted that the public has a limited 
        understanding of the benefits and risks of drugs. The workshop 
        also highlighted that it is important to--
                    (i) provide patients and physicians with the best 
                possible information for making informed decisions 
                about the use of pharmaceuticals;
                    (ii) employ quantitative and standardized 
                approaches when trying to evaluate pharmaceutical 
                benefit-risk; and
                    (iii) develop and validate improved tools for 
                communicating pharmaceutical benefit-risk information 
                to patients and physicians.
            (B) The general agreement of the workshop was that the Food 
        and Drug Administration should pilot test a drug facts box.
            (3) On February 27, 2009, the Food and Drug 
        Administration's Risk Communication Advisory Committee made the 
        following unanimous recommendations:
                    (A) The Food and Drug Administration should adopt a 
                single standard document for communicating essential 
                information about pharmaceuticals.
                    (B) That standard document should include 
                quantitative summaries of risks and benefits, along 
                with use and precaution information.
                    (C) The Food and Drug Administration should adopt 
                the drug facts box format as its standard.

SEC. 3. PRESENTATION OF DRUG BENEFIT AND RISK INFORMATION.

    (a) In General.--The Secretary of Health and Human Services 
(referred to in this Act as the ``Secretary''), acting through the 
Commissioner of Food and Drugs, shall determine whether standardized, 
quantitative summaries of the benefits and risks of drugs in a tabular 
or drug facts box format, or any alternative format, in the labeling 
and print advertising of such drugs would improve health care 
decisionmaking by clinicians and patients and consumers.
    (b) Review and Consultation.--In making the determination under 
subsection (a), the Secretary shall review all available scientific 
evidence and consult with drug manufacturers, clinicians, patients and 
consumers, experts in health literacy, and representatives of racial 
and ethnic minorities.
    (c) Report.--Not later than 1 year after the date of enactment of 
this Act, the Secretary shall submit to the Congress a report that 
provides--
            (1) the determination by the Secretary under subsection 
        (a); and
            (2) the reasoning and analysis underlying that 
        determination.
    (d) Authority.--
            (1) In general.--If the Secretary determines under 
        subsection (a) that standardized, quantitative summaries of the 
        benefits and risks of drugs in a tabular or drug facts box 
        format, or any alternative format, in the labeling and print 
        advertising of such drugs would improve health care 
        decisionmaking by clinicians and patients and consumers, then 
        the Secretary, not later than 1 year after the date of 
        submission of the report under subsection (c), shall promulgate 
        regulations as necessary to implement such format.
            (2) Objective and up-to-date information.--In carrying out 
        paragraph (1), the Secretary shall ensure that the information 
        presented in a summary described under such paragraph is 
        objective and up-to-date, and is the result of a review process 
        that considers the totality of published and unpublished data.
            (3) Posting of information.--In carrying out paragraph (1), 
        the Secretary shall post the information presented in a summary 
        described under such paragraph on the Internet Web site of the 
        Food and Drug Administration.

SEC. 4. STANDARDS FOR COMPARATIVE CLINICAL EFFECTIVENESS INFORMATION.

    (a) In General.--The Secretary, acting through the Commissioner of 
Food and Drugs, shall establish and periodically update methodological 
standards and criteria for the sources of evidence and the adequacy and 
degree of evidence that are appropriate for inclusion of comparative 
clinical effectiveness information in labeling and advertisements under 
subsections (f), (n)(3), and (r) of section 502 of the Federal Food, 
Drug, and Cosmetic Act (as amended by section 5).
    (b) Requirements.--The standards and criteria established under 
subsection (a) shall ensure that comparative clinical effectiveness 
information provides reliable and useful information that improves 
health care decisionmaking, adheres to rigorous scientific standards, 
and is produced through a transparent process that includes 
consultation with stakeholders.
    (c) Consultation.--In carrying out subsection (a), the Secretary 
shall consult with manufacturers of drugs and devices, clinicians, 
patients and consumers, experts in health literacy, and representatives 
of racial and ethnic minorities.
    (d) Definition.--For purposes of this section, the term 
``comparative clinical effectiveness'' means the clinical outcomes, 
effectiveness, safety, and clinical appropriateness of a drug or device 
in comparison to 1 or more drugs or devices, respectively, approved to 
prevent, diagnose, or treat the same health condition for the same 
patient demographic subpopulation.

SEC. 5. DISCLOSURE OF COMPARATIVE CLINICAL EFFECTIVENESS INFORMATION.

    (a) Comparative Clinical Effectiveness.--Section 201 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 321) is amended by adding at 
the end the following:
    ``(rr) The term `comparative clinical effectiveness' means the 
clinical outcomes, effectiveness, safety, and clinical appropriateness 
of a drug or device in comparison to 1 or more drugs or devices, 
respectively, approved to prevent, diagnose, or treat the same health 
condition for the same patient demographic subpopulation, on the basis 
of research that meets standards adopted by the Secretary under section 
4 of the Informed Health Care Decision Making Act.''.
    (b) Labeling and Advertising Information.--Section 502 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352) is amended--
            (1) in subsection (f), by striking ``for use; and (2)'' and 
        inserting ``for use; (2) such information in brief summary 
        relating to comparative clinical effectiveness as shall be 
        required in regulations which shall be issued by the Secretary 
        in accordance with the procedure specified in section 701(a); 
        and (3)'';
            (2) in subsection (n)(3), by striking ``and effectiveness'' 
        and inserting ``effectiveness, and comparative clinical 
        effectiveness (or a disclosure that there is no such 
        information relating to comparative clinical effectiveness if 
        another drug has been approved for the same use),''; and
            (3) in subsection (r)--
                    (A) by striking ``In the case of any'' and 
                inserting ``(1) In the case of any'';
                    (B) by striking ``(1) a true'' and inserting ``(A) 
                a true'';
                    (C) by striking ``(2) a brief'' and inserting ``(B) 
                a brief''; and
                    (D) by striking ``and contraindications'' and 
                inserting ``contraindications, and, if appropriate 
                after taking into consideration the type of device, 
                effectiveness and comparative clinical effectiveness 
                (or a disclosure that there is no such information 
                relating to comparative clinical effectiveness if 
                another device has been approved for the same use)''.
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