H.R.2245 - Preserving Access to Life-Saving Medications Act of 2011112th Congress (2011-2012)
Summary: H.R.2245 — 112th Congress (2011-2012)
Introduced in House (06/21/2011)
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 the Secretary that a drug may be vulnerable to a drug shortage, and (2) the Secretary's duty to collaborate to improve continuity of supply. Prohibits the Secretary from requiring a manufacturer to: (1) manufacture a drug in the event of a discontinuance or interruption, or (2) delay or alter a discontinuance or interruption.
Declares that no provision of federal law shall be construed to prohibit a manufacturer from, or penalize a manufacturer for, allocating distribution of its products in order to manage an actual or potential drug shortage.
Requires the Comptroller General to examine issues related to drug shortages.