Informed Health Care Decision Making Act

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.

This text is taken from the official record. PoliticalRepo does not editorialize.

Timeline

No timeline events have been ingested for this record yet.

Votes

No vote records are attached yet.

Versions

No version snapshots stored. Document URLs remain at the source.

Documents

3 official files

• Introduced in Senate (text)

  Introduced in Senate · EN · 21 May 2009

  ViewDownloadOpen at official source

• Introduced in Senate (PDF)

  Introduced in Senate · EN · 21 May 2009

  ViewDownloadOpen at official source

• Introduced in Senate

  summary · EN · 21 May 2009

  Open at official source

Sponsors

No sponsors or actors listed by the source.

Related records

No cross-record relationships stored yet.