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H.R. 2245 · 112th Congress

Preserving Access to Life-Saving Medications Act of 2011

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Never voted on. It didn't reach a floor vote before the 112th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.

DDD DeGetteSponsor
96 cosponsors · 73 D, 23 R
TRR Rooney GCD Connolly TLR Latham ECD Cummings WJR Jones LSD Slaughter KED Ellison JLD Lewis GKD Butterfield HJD Johnson NLD Lowey JMD McGovern MQD Quigley JLD Langevin JMD Moran AED Eshoo END Norton GND Napolitano PDD DeFazio CPD Pingree DCD Cicilline BMD McCollum MMD Michaud JSD Schakowsky JTD Tierney MHD Hinchey DLD Lipinski DLD Loebsack JND Nadler SRD Rothman TPR Platts MRR Roby LWD Woolsey DRR Ross CYR Young AWR West SWR Womack JCD Carney MDR Diaz-Balart LBD Boswell MBD Bordallo RGD Grijalva SID Israel CMD Maloney JYD Yarmuth PKR King KCD Castor BLD Lee GMD Moore JSD Sarbanes CVD Van Hollen DYR Young SCR Capito JCD Costa MHD Heinrich SRD Reyes BPD Pascrell JCD Cooper ASD Schwartz SCD Cohen EPD Pastor JAD Altmire LCD Capps MMR McCaul JHD Hahn EBD Blumenauer JCD Courtney MFR Fitzpatrick MCD Critz LRD Richardson GAD Ackerman MBR Brooks LBR Bucshon BBD Braley RDD DeLauro TDD Deutch ZLD Lofgren JSD Speier MTD Thompson RBR Bartlett DRR Rohrabacher DKD Kildee SBR Bachus CPD Peterson SBD Bonamici MDD Doyle SBD Bishop RLD Larsen ACR Crenshaw JMD McDermott MKD Kaptur WKD Keating JHD Himes JHR Heck GBR Bilirakis DBD Boren

1 signed on when it was introduced; the rest joined later. Cosponsors who withdrew aren't shown.

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.

What it does: CRS summary · Introduced in House · Jun 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.

Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov

About this bill and sources

Official title: Preserving Access to Life-Saving Medications Act of 2011

Latest action (Jun 22, 2011): Referred to the Subcommittee on Health.

Policy area: Health · Origin: House · Introduced: Jun 21, 2011

Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)

No recorded floor vote found.