HR 2245 · 112th Congress · Health

Preserving Access to Life-Saving Medications Act of 2011

Introduced 2011-06-21· Sponsored by Rep. DeGette, Diana [D-CO-1]· House

Bill Progress

Introduced
2
Committee
3
House Vote
4
Senate
5
Enacted
Latest: Referred to the Subcommittee on Health.(2011-06-22)

Plain Language Summary

[AI summary unavailable — showing source text] Preserving Access to Life-Saving Medications Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act to require the manufacturer of a prescription drug marketed in interstate commerce to notify the Secretary of Health and Human Services (HHS) of a discontinuance or interruption in the manufacture of such drug. Requires the notification to be submitted six months prior to the date of a discontinuance or interruption, if possible. Allows the reduction of the notification period if the manufacturer certifies to the Secretary that good cause exists for the reduction. Authorizes the Secretary to reduce the notification period based on the type of discontinuance or interruption at issue or any other factor. Treats any information provided to the Secretary under this Act as a trade secret or confidential information. Establishes civil monetary penalties for violations. Requires the Secretary to publish on the website of the Food and Drug Administration (FDA) and distribute to the appropriate health care providers and patient organizations information on discontinuances, interruptions, and drug shortages. Requires the Secretary to notify a manufacturer of: (1) any determination by th…

Summarized by Claude AI · Non-partisan · For informational purposes only

Cosponsors (20)

17 Democrats3 Republicans