Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text of measure as introduced: CR S5849-5850)
Congressional Research Service
Official summary
Version 00 · Introduced in Senate · May 21, 2009
Informed Health Care Decision Making Act - Requires the Commissioner of Food and Drugs (FDA) to: (1) determine whether standardized, quantitative summaries of the benefits and risks of drugs in a tabular or drug facts box format would improve health care decisionmaking by clinicians, patients, and consumers; and (2) establish and update standards for comparative clinical effectiveness information in the labeling and advertising of drugs and devices under the Federal Food, Drug, and Cosmetic Act. Defines "comparative clinical effectiveness" as the clinical outcomes, effectiveness, safety, and clinical appropriateness of a drug or device in comparison to one or more drugs or devices approved to prevent, diagnose, or treat the same health condition in the same patient demographic subpopulation.
Amends the Federal Food, Drug, and Cosmetic Act to require information on comparative clinical effectiveness for drugs and devices in labeling and advertising.
No related bills are listed in this snapshot. This does not establish whether the proposal has appeared in earlier Congresses.
Source last updated: Aug 14, 2025. Consult Congress.gov for the current record.
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