S. 1142 would amend the Federal Food, Drug, and Cosmetic Act with respect to inclusion of effectiveness information in drug and device labeling and advertising.
Detailed Summary
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.
Status of the Legislation
Latest Major Action: 5/21/2009: Referred to Senate committee. Status: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
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