II
111th CONGRESS
1st Session
S. 1142
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.
Short title
This Act may be cited as the
Informed Health Care Decision Making
Act
.
Findings
Congress finds the following:
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.
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—
provide patients and physicians with the best possible information for making informed decisions about the use of pharmaceuticals;
employ quantitative and standardized approaches when trying to evaluate pharmaceutical benefit-risk; and
develop and validate improved tools for communicating pharmaceutical benefit-risk information to patients and physicians.
The general agreement of the workshop was that the Food and Drug Administration should pilot test a drug facts box.
On February 27, 2009, the Food and Drug Administration's Risk Communication Advisory Committee made the following unanimous recommendations:
The Food and Drug Administration should adopt a single standard document for communicating essential information about pharmaceuticals.
That standard document should include quantitative summaries of risks and benefits, along with use and precaution information.
The Food and Drug Administration should adopt the drug facts box format as its standard.
Presentation of drug benefit and risk information
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.
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.
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—
the determination by the Secretary under subsection (a); and
the reasoning and analysis underlying that determination.
Authority
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.
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.
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.
Standards for comparative clinical effectiveness information
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).
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.
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.
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.
Disclosure of comparative clinical effectiveness information
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:
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.
.
Labeling and advertising information
Section 502 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352) is amended—
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)
;
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
in subsection (r)—
by striking In the case of
any
and inserting (1) In the case of any
;
by striking (1) a true
and
inserting (A) a true
;
by striking (2) a brief
and
inserting (B) a brief
; and
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)
.