US Congress House Bill 2245 (Prior Session Legislation)

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June 22 2011 - Referred to the Subcommittee on Health.
Pending: House Subcommittee on Health Committee
Text: Latest bill text (Introduced) [PDF]

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.

Preserving Access to Life-Saving Medications Act of 2011

Rep DeGette, Diana	Rep Ackerman, Gary L.	Rep Altmire, Jason	Rep Bachus, Spencer
Rep Bartlett, Roscoe G.	Rep Bilirakis, Gus M.	Rep Bishop, Sanford D., Jr.	Rep Blumenauer, Earl
Rep Bonamici, Suzanne	Rep Bordallo, Madeleine Z.	Rep Boren, Dan	Rep Boswell, Leonard L.
Rep Braley, Bruce L.	Rep Brooks, Mo	Rep Bucshon, Larry	Rep Butterfield, G. K.
Rep Capito, Shelley Moore	Rep Capps, Lois	Rep Carney, John	Rep Castor, Kathy
Rep Cicilline, David N.	Rep Cohen, Steve	Rep Connolly, Gerald E. "Gerry"	Rep Cooper, Jim
Rep Costa, Jim	Rep Courtney, Joe	Rep Crenshaw, Ander	Rep Critz, Mark S.
Rep Cummings, Elijah E.	Rep DeFazio, Peter A.	Rep DeLauro, Rosa L.	Rep Deutch, Theodore E.
Rep Diaz-Balart, Mario	Rep Doyle, Michael F.	Rep Ellison, Keith	Rep Eshoo, Anna G.
Rep Fitzpatrick, Michael G.	Rep Grijalva, Raul M.	Rep Hahn, Janice	Rep Heck, Joseph J.
Rep Heinrich, Martin	Rep Himes, James A.	Rep Hinchey, Maurice D.	Rep Israel, Steve
Rep Johnson, Henry C. "Hank," Jr.	Rep Jones, Walter B., Jr.	Rep Kaptur, Marcy	Rep Keating, William R.
Rep Kildee, Dale E.	Rep King, Peter T.	Rep Langevin, James R.	Rep Larsen, Rick
Rep Latham, Tom	Rep Lee, Barbara	Rep Lewis, John	Rep Lipinski, Daniel
Rep Loebsack, David	Rep Lofgren, Zoe	Rep Lowey, Nita M.	Rep Maloney, Carolyn B.
Rep McCaul, Michael T.	Rep McCollum, Betty	Rep McDermott, Jim	Rep McGovern, James P.
Rep Michaud, Michael H.	Rep Moore, Gwen	Rep Moran, James P.	Rep Nadler, Jerrold
Rep Napolitano, Grace F.	Rep Norton, Eleanor Holmes	Rep Pascrell, Bill, Jr.	Rep Pastor, Ed
Rep Peterson, Collin C.	Rep Pingree, Chellie	Rep Platts, Todd Russell	Rep Quigley, Mike
Rep Reyes, Silvestre	Rep Richardson, Laura	Rep Roby, Martha	Rep Rohrabacher, Dana
Rep Rooney, Thomas J.	Rep Ross, Dennis	Rep Rothman, Steven R.	Rep Sarbanes, John P.
Rep Schakowsky, Janice D.	Rep Schwartz, Allyson Y.	Rep Slaughter, Louise McIntosh	Rep Speier, Jackie
Rep Thompson, Mike	Rep Tierney, John F.	Rep Van Hollen, Chris	Rep West, Allen B.
Rep Womack, Steve	Rep Woolsey, Lynn C.	Rep Yarmuth, John A.	Rep Young, C.W. Bill
Rep Young, Don

Date	Chamber	Action
2011-06-22	House	Referred to the Subcommittee on Health.
2011-06-21	House	Referred to the House Committee on Energy and Commerce.

Type	Source
Summary	http://thomas.loc.gov/cgi-bin/bdquery/z?d112:HN02245:@@@L&summ2=m&
Text	http://gpo.gov/fdsys/pkg/BILLS-112hr2245ih/pdf/BILLS-112hr2245ih.pdf