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HR 2245 112th Congress House

Preserving Access to Life-Saving Medications Act of 2011

Official title: To amend the Federal Food, Drug, and Cosmetic Act to provide the Food and Drug Administration with improved capacity to prevent drug shortages.

Introduced: July 19, 2011 Introduced by: DeGette, Diana Democratic · Colorado See on congress.gov
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Government studies and investigationsHealth care coverage and accessManufacturingPrescription drugs
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This bill died when the 112th Congress ended
It never became law before the 112th Congress (2011–2012) adjourned, and bills don't carry over to the next Congress. It would have to be reintroduced. You can still save it for reference, but it won't receive updates.
 Everywhere this bill has been 3 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Jun 22, 2011
Referred to the Subcommittee on Health.
Jun 21, 2011
Introduced in House
Jun 21, 2011
Referred to the House Committee on Energy and Commerce.
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 Latest action June 22, 2011

Referred to the Subcommittee on Health.

 Plain-English summary Congressional Research Service

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.

 Bill text 1 version

Source documents hosted by congress.gov.

 Committees of jurisdiction 2
 Cosponsors 77
All 77 Democratic 24 Republican 5
Boren, Dan
· Sep 14, 2012
 R
Bilirakis, Gus M.
Florida · Jul 23, 2012
 D
Himes, James A.
Connecticut · May 31, 2012
 D
Kaptur, Marcy
Ohio · May 30, 2012
 D
Keating, William R.
Massachusetts · May 30, 2012
CRENSHAW, ANDER
· May 25, 2012
 D
Larsen, Rick
Washington · May 18, 2012
 D
Bishop, Sanford D.
Georgia · May 10, 2012
DOYLE, MIKE
· May 9, 2012
 D
Bonamici, Suzanne
Oregon · Apr 26, 2012
PETERSON, COLLIN
· Apr 25, 2012
ROHRABACHER, DANA
· Mar 29, 2012
BARTLETT, ROSCOE
· Mar 28, 2012
 D
DeLauro, Rosa L.
Connecticut · Mar 26, 2012
Deutch, Theodore
· Mar 26, 2012
 D
Lofgren, Zoe
California · Mar 26, 2012
Speier, Jackie
· Mar 26, 2012
 D
Thompson, Mike
California · Mar 26, 2012
Bucshon, Larry
· Mar 7, 2012
ACKERMAN, GARY
· Mar 6, 2012
Brooks, Mo
· Mar 6, 2012
Richardson, Laura
· Feb 29, 2012
Blumenauer, Earl
· Feb 27, 2012
 D
Courtney, Joe
Connecticut · Feb 27, 2012
 R
McCaul, Michael T.
Texas · Feb 15, 2012
Altmire, Jason
· Jan 25, 2012
 D
Cohen, Steve
Tennessee · Dec 20, 2011
PASTOR, ED
· Dec 20, 2011
COOPER, JAMES
· Dec 12, 2011
Pascrell, Bill
· Dec 1, 2011
REYES, SILVESTRE
· Nov 15, 2011
 R
Capito, Shelley Moore
West Virginia · Nov 4, 2011
 D
Costa, Jim
California · Nov 4, 2011
 D
Heinrich, Martin
New Mexico · Nov 4, 2011
 D
Castor, Kathy
Florida · Nov 1, 2011
Lee, Barbara
· Nov 1, 2011
 D
Moore, Gwen
Wisconsin · Nov 1, 2011
Sarbanes, John
· Nov 1, 2011
 D
Van Hollen, Chris
Maryland · Nov 1, 2011
YOUNG, DON
· Nov 1, 2011
KING, PETER
· Oct 27, 2011
BOSWELL, LEONARD
· Oct 25, 2011
 D
Grijalva, Raúl M.
Arizona · Oct 25, 2011
MALONEY, CAROLYN
· Oct 25, 2011
Yarmuth, John
· Oct 25, 2011
 R
Diaz-Balart, Mario
Florida · Oct 14, 2011
 R
Womack, Steve
Arkansas · Oct 13, 2011
Ross, Dennis
· Oct 6, 2011
PLATTS, TODD
· Oct 5, 2011
Roby, Martha
· Oct 5, 2011
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APA
U.S. Congress. (2026). H.R. 2245: Preserving Access to Life-Saving Medications Act of 2011. 112th Congress. Open America. https://openamerica.io/bill/112-HR-2245/
MLA
"H.R. 2245: Preserving Access to Life-Saving Medications Act of 2011." 112th Congress, 2026, Open America, https://openamerica.io/bill/112-HR-2245/.
Bluebook (legal)
H.R. 2245, 112th Cong. (2026), https://openamerica.io/bill/112-HR-2245/.
Markdown link
[H.R. 2245: Preserving Access to Life-Saving Medications Act of 2011](https://openamerica.io/bill/112-HR-2245/)
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