[Congressional Record Volume 155, Number 79 (Thursday, May 21, 2009)]
[Senate]
[Pages S5848-S5850]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. REED (for himself and Ms. Mikulski):
  S. 1142. 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; to the Committee on Health, Education, 
Labor, and Pensions.
  Mr. REED. Mr. President, today I introduce the Informed Health Care 
Decision Making Act of 2009. I am introducing this legislation along 
with my colleague Senator Mikulski because every American deserves to 
have the full information regarding drugs and devices prescribed by 
their provider.
  Even though the amount of money spent to reach the public about drugs 
and devices is greater than five billion dollars annually, the most 
fundamental information--information about how well the drug or device 
actually works--is generally absent. In 2007, the Institute of Medicine 
conducted a workshop regarding the public's understanding of drugs and 
confirmed the importance for patients and physicians of having 
standardized and quantitative information about the product before 
making health care decisions.
  Researchers at Dartmouth University have documented that replacing 
the current narrative information contained in drug advertisements with 
simplified, factual information, will enable patients to play an active 
role in health care decision making. In fact, similar to the nutrition 
facts boxes that are required on our Nation's packaged food supply, 
this research demonstrated that a drug facts box will actually help 
physicians make better health care choices.
  If the research is not enough proof that this type of streamlined 
information will be beneficial, the Food and

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Drug Administration's, FDA, Risk Communications Advisory Committee, a 
committee specifically designed to counsel the agency on how to 
strengthen the communication of risks and benefits of FDA-regulated 
products to the public, unanimously recommended that the FDA adopt 
standardized, quantitative summaries of risks and benefits in a drug 
facts box format.
  As such, the Informed Health Care Decision Making Act of 2009 would 
require the FDA to determine if the information provided in a drug 
facts box, or a similar format, would improve health care decision 
making by clinicians and patients, and report to Congress on that 
determination. If the report determines that a specific standardized, 
quantitative format would be beneficial, the FDA must issue regulations 
to implement the format.
  Regardless of the FDA's determination, it is important for clinicians 
and patients to be able to compare the similarities, differences, 
benefits, and risks of drugs and devices. As such, the legislation 
would require the Agency for Healthcare Research and Quality to 
establish a multi-stakeholder process for developing and periodically 
updating methodological standards and criteria for comparative clinical 
effectiveness research. This would include standards and criteria for 
the sources of evidence and the adequacy of evidence that are 
appropriate for the inclusion of comparative clinical effectiveness 
information in labeling and print advertisements.
  Upon completion of these standards, the legislation requires drug 
labels and print advertisements to include information on the clinical 
effectiveness of a product--compared to other products approved for the 
same health condition for the same patient demographic subpopulation--
or a disclosure that there is no such information, if another product 
has not been approved for the same use. The potential of such a 
disclosure should be a powerful incentive for manufacturers to fund 
comparative effectiveness research.
  It is my hope that as we embark upon meaningful health care reform, 
my colleagues will join me in supporting this bill and other 
initiatives to improve the health care decision making of both patients 
and clinicians.
  Mr. President, I ask unanimous consent that the text of the bill be 
printed in the Record.
  There being no objection, the text of the bill was ordered to be 
printed in the Record, as follows:

                                S. 1142

       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 decision making 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 
     decision making 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 decision making, 
     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

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       (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)''.
                                 ______