US Congress House Bill 2245 (Prior Session Legislation)

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Spectrum: Moderate Partisan Bill (Democrat 74-23)
Status: Introduced on June 21 2011 - 25% progression, died in committee
Action: 2011-06-22 - 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. Diana DeGette [D-CO]	Rep. Gary Ackerman [D-NY]	Rep. Jason Altmire [D-PA]	Rep. Spencer Bachus [R-AL]
Rep. Roscoe Bartlett [R-MD]	Rep. Gus Bilirakis [R-FL]	Rep. Sanford Bishop [D-GA]	Rep. Earl Blumenauer [D-OR]
Rep. Suzanne Bonamici [D-OR]	Rep. Madeleine Bordallo [D-GU]	Rep. Dan Boren [D-OK]	Rep. Leonard Boswell [D-IA]
Rep. Bruce Braley [D-IA]	Rep. Mo Brooks [R-AL]	Rep. Larry Bucshon [R-IN]	Rep. G. Butterfield [D-NC]
Sen. Shelley Capito [R-WV]	Rep. Lois Capps [D-CA]	Rep. John Carney [D-DE]	Rep. Kathy Castor [D-FL]
Rep. David Cicilline [D-RI]	Rep. Steve Cohen [D-TN]	Rep. Gerald Connolly [D-VA]	Rep. Jim Cooper [D-TN]
Rep. Jim Costa [D-CA]	Rep. Joe Courtney [D-CT]	Rep. Ander Crenshaw [R-FL]	Rep. Mark Critz [D-PA]
Rep. Elijah Cummings [D-MD]	Rep. Peter DeFazio [D-OR]	Rep. Rosa DeLauro [D-CT]	Rep. Theodore Deutch [D-FL]
Rep. Mario Diaz-Balart [R-FL]	Rep. Michael Doyle [D-PA]	Rep. Keith Ellison [D-MN]	Rep. Anna Eshoo [D-CA]
Rep. Michael Fitzpatrick [R-PA]	Rep. Raul Grijalva [D-AZ]	Rep. Janice Hahn [D-CA]	Rep. Joseph Heck [R-NV]
Sen. Martin Heinrich [D-NM]	Rep. James Himes [D-CT]	Rep. Maurice Hinchey [D-NY]	Rep. Steve Israel [D-NY]
Rep. Henry Johnson [D-GA]	Rep. Walter Jones [R-NC]	Rep. Marcy Kaptur [D-OH]	Rep. William Keating [D-MA]
Rep. Dale Kildee [D-MI]	Rep. Peter King [R-NY]	Rep. James Langevin [D-RI]	Rep. Rick Larsen [D-WA]
Rep. Tom Latham [R-IA]	Rep. Barbara Lee [D-CA]	Rep. John Lewis [D-GA]	Rep. Daniel Lipinski [D-IL]
Rep. David Loebsack [D-IA]	Rep. Zoe Lofgren [D-CA]	Rep. Nita Lowey [D-NY]	Rep. Carolyn Maloney [D-NY]
Rep. Michael McCaul [R-TX]	Rep. Betty McCollum [D-MN]	Rep. Jim McDermott [D-WA]	Rep. James McGovern [D-MA]
Rep. Michael Michaud [D-ME]	Rep. Gwen Moore [D-WI]	Rep. James Moran [D-VA]	Rep. Jerrold Nadler [D-NY]
Rep. Grace Napolitano [D-CA]	Rep. Eleanor Norton [D-DC]	Rep. Bill Pascrell [D-NJ]	Rep. Ed Pastor [D-AZ]
Rep. Collin Peterson [D-MN]	Rep. Chellie Pingree [D-ME]	Rep. Todd Platts [R-PA]	Rep. Mike Quigley [D-IL]
Rep. Silvestre Reyes [D-TX]	Rep. Laura Richardson [D-CA]	Rep. Martha Roby [R-AL]	Rep. Dana Rohrabacher [R-CA]
Rep. Thomas Rooney [R-FL]	Rep. Dennis Ross [R-FL]	Rep. Steven Rothman [D-NJ]	Rep. John Sarbanes [D-MD]
Rep. Janice Schakowsky [D-IL]	Rep. Allyson Schwartz [D-PA]	Rep. Louise Slaughter [D-NY]	Rep. Jackie Speier [D-CA]
Rep. Mike Thompson [D-CA]	Rep. John Tierney [D-MA]	Sen. Chris Van Hollen [D-MD]	Rep. Allen West [R-FL]
Rep. Steve Womack [R-AR]	Rep. Lynn Woolsey [D-CA]	Rep. John Yarmuth [D-KY]	Rep. C.W. Young [R-FL]
Rep. Don Young [R-AK]

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	https://www.congress.gov/bill/112th-congress/house-bill/2245/all-info
Text	https://www.congress.gov/112/bills/hr2245/BILLS-112hr2245ih.pdf