Preserving Access to Life-Saving Medications Act of 2011
Latest action · Jun 22, 2011 Referred to the Subcommittee on Health.
Progress
Where this bill reached, and when. A stage with no date was not reached; one that failed a vote and later carried shows the date it carried.
- IntroducedJun 21, 2011
- Passed HouseNot reached
- Passed SenateNot reached
- To the PresidentNot reached
- Became lawNot reached
Summary
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.
Cosponsors 96
Members who signed on, in the order they did. Signatures ran from Jun 21, 2011 to Sep 14, 2012; 1 is an original cosponsor, there from the day it was introduced.
| Seat | Cosponsor | Signed on | |
|---|---|---|---|
| R-FL | Thomas J. Rooney | Original | Jun 21, 2011 |
| D-VA | Gerald E. Connolly | Jul 7, 2011 | |
| R-IA | Tom Latham | Jul 7, 2011 | |
| D-MD | Elijah E. Cummings | Jul 13, 2011 | |
| D-NY | Louise McIntosh Slaughter | Jul 19, 2011 | |
| R-NC | Walter B. Jones | Jul 19, 2011 | |
| D-MN | Keith Ellison | Jul 20, 2011 | |
| D-GA | John Lewis | Jul 21, 2011 | |
| D-NC | G. K. Butterfield | Aug 5, 2011 | |
| D-GA | Henry C. "Hank" Johnson, Jr. | Sep 7, 2011 | |
| D-MA | James P. McGovern | Sep 7, 2011 | |
| D-IL | Mike Quigley | Sep 7, 2011 | |
| D-NY | Nita M. Lowey | Sep 7, 2011 | |
| D-VA | James P. Moran | Sep 12, 2011 | |
| D-RI | James R. Langevin | Sep 12, 2011 | |
| D-CA | Anna G. Eshoo | Sep 14, 2011 | |
| D-DC | Eleanor Holmes Norton | Sep 14, 2011 | |
| D-CA | Grace F. Napolitano | Sep 14, 2011 | |
| D-ME | Chellie Pingree | Sep 15, 2011 | |
| D-OR | Peter A. DeFazio | Sep 15, 2011 | |
| D-MN | Betty McCollum | Sep 22, 2011 | |
| D-RI | David N. Cicilline | Sep 22, 2011 | |
| D-IL | Janice D. Schakowsky | Sep 22, 2011 | |
| D-MA | John F. Tierney | Sep 22, 2011 | |
| D-ME | Michael H. Michaud | Sep 22, 2011 | |
| D-IL | Daniel Lipinski | Oct 3, 2011 | |
| D-IA | David Loebsack | Oct 3, 2011 | |
| D-NY | Jerrold Nadler | Oct 3, 2011 | |
| D-NY | Maurice D. Hinchey | Oct 3, 2011 | |
| D-NJ | Steven R. Rothman | Oct 3, 2011 | |
| D-CA | Lynn C. Woolsey | Oct 5, 2011 | |
| R-AL | Martha Roby | Oct 5, 2011 | |
| R-PA | Todd Russell Platts | Oct 5, 2011 | |
| R-FL | C. W. Bill Young | Oct 6, 2011 | |
| R-FL | Dennis A. Ross | Oct 6, 2011 | |
| R-FL | Allen B. West | Oct 13, 2011 | |
| R-AR | Steve Womack | Oct 13, 2011 | |
| D-DE | John C. Carney, Jr. | Oct 14, 2011 | |
| R-FL | Mario Diaz-Balart | Oct 14, 2011 | |
| D-NY | Carolyn B. Maloney | Oct 25, 2011 | |
| D-KY | John A. Yarmuth | Oct 25, 2011 | |
| D-IA | Leonard L. Boswell | Oct 25, 2011 | |
| D-GU | Madeleine Z. Bordallo | Oct 25, 2011 | |
| D-AZ | Raúl M. Grijalva | Oct 25, 2011 | |
| D-NY | Steve Israel | Oct 25, 2011 | |
| R-NY | Peter T. King | Oct 27, 2011 | |
| D-CA | Barbara Lee | Nov 1, 2011 | |
| D-MD | Chris Van Hollen | Nov 1, 2011 | |
| R-AK | Don Young | Nov 1, 2011 | |
| D-WI | Gwen Moore | Nov 1, 2011 | |
| D-MD | John P. Sarbanes | Nov 1, 2011 | |
| D-FL | Kathy Castor | Nov 1, 2011 | |
| D-CA | Jim Costa | Nov 4, 2011 | |
| D-NM | Martin Heinrich | Nov 4, 2011 | |
| R-WV | Shelley Moore Capito | Nov 4, 2011 | |
| D-TX | Silvestre Reyes | Nov 15, 2011 | |
| D-NJ | Bill Pascrell, Jr. | Dec 1, 2011 | |
| D-PA | Allyson Y. Schwartz | Dec 12, 2011 | |
| D-TN | Jim Cooper | Dec 12, 2011 | |
| D-AZ | Ed Pastor | Dec 20, 2011 | |
| D-TN | Steve Cohen | Dec 20, 2011 | |
| D-PA | Jason Altmire | Jan 25, 2012 | |
| D-CA | Lois Capps | Feb 7, 2012 | |
| R-TX | Michael T. McCaul | Feb 15, 2012 | |
| D-CA | Janice Hahn | Feb 17, 2012 | |
| D-OR | Earl Blumenauer | Feb 27, 2012 | |
| D-CT | Joe Courtney | Feb 27, 2012 | |
| R-PA | Michael G. Fitzpatrick | Feb 27, 2012 | |
| D-CA | Laura Richardson | Feb 29, 2012 | |
| D-PA | Mark S. Critz | Feb 29, 2012 | |
| D-NY | Gary L. Ackerman | Mar 6, 2012 | |
| R-AL | Mo Brooks | Mar 6, 2012 | |
| R-IN | Larry Bucshon | Mar 7, 2012 | |
| D-IA | Bruce L. Braley | Mar 8, 2012 | |
| D-CA | Jackie Speier | Mar 26, 2012 | |
| D-CA | Mike Thompson | Mar 26, 2012 | |
| D-CT | Rosa L. DeLauro | Mar 26, 2012 | |
| D-FL | Theodore E. Deutch | Mar 26, 2012 | |
| D-CA | Zoe Lofgren | Mar 26, 2012 | |
| R-MD | Roscoe G. Bartlett | Mar 28, 2012 | |
| R-CA | Dana Rohrabacher | Mar 29, 2012 | |
| D-MI | Dale E. Kildee | Apr 17, 2012 | |
| R-AL | Spencer Bachus | Apr 19, 2012 | |
| D-MN | Collin C. Peterson | Apr 25, 2012 | |
| D-OR | Suzanne Bonamici | Apr 26, 2012 | |
| D-PA | Michael F. Doyle | May 9, 2012 | |
| D-GA | Sanford D. Bishop, Jr. | May 10, 2012 | |
| D-WA | Rick Larsen | May 18, 2012 | |
| R-FL | Ander Crenshaw | May 25, 2012 | |
| D-WA | Jim McDermott | May 25, 2012 | |
| D-OH | Marcy Kaptur | May 30, 2012 | |
| D-MA | William R. Keating | May 30, 2012 | |
| D-CT | James A. Himes | May 31, 2012 | |
| R-NV | Joseph J. Heck | May 31, 2012 | |
| R-FL | Gus M. Bilirakis | Jul 23, 2012 | |
| D-OK | Dan Boren | Sep 14, 2012 |
Committees 1
Where it was sent and what each committee and subcommittee did with it, in order.
| Chamber | Committee | What it did |
|---|---|---|
| House | Energy and Commerce Committee | Referred Jun 21, 2011 |
| Health Subcommittee | Referred Jun 22, 2011 |
Actions 3
Everything that happened, newest first.
- Jun 22, 2011Referred to the Subcommittee on Health.
- Jun 21, 2011Introduced in House
- Jun 21, 2011Referred to the House Committee on Energy and Commerce.
In the Congressional Record 1
Days the Record’s own index lists this bill, newest first, with the pages and the members it names. Pages starting H are the House, S the Senate, E Extensions of Remarks.
| Where | In the Record | Members | Date |
|---|---|---|---|
| House | Debate and remarks H3863 | Diana DeGette D-CO | Jun 20, 2012 |
Research
What has been written about this bill: committee reports, cost estimates, the sponsor’s authority statement, printed hearings and the Congressional Research Service’s work.
Constitutional authority
The sponsor’s statement, as printed in the page H4364.
Printed hearings 5
Hearings whose printed record names this bill, newest first: hearings on it, and wider hearings where it came up.
| Number | Hearing | Committee | Held |
|---|---|---|---|
| Serial No. 112-114 | REVIEW OF THE PROPOSED GENERIC DRUG AND BIOSIMILARS USER FEES AND FURTHER EXAMINATION OF DRUG SHORTAGES198 pages | Energy and Commerce Committee | Feb 9, 2012 |
| S. Hrg. 112-885 | PRESCRIPTION DRUG SHORTAGES: EXAMINING A PUBLIC HEALTH CONCERN AND POTENTIAL SOLUTIONS98 pages | Health, Education, Labor, and Pensions Committee | Dec 15, 2011 |
| Serial No. 112-102 | DRUG SHORTAGE CRISIS: LIVES ARE IN THE BALANCE71 pages | Oversight and Government Reform Committee | Nov 30, 2011 |
| Serial No. 112-88 | EXAMINING THE INCREASE IN DRUG SHORTAGES166 pages | Energy and Commerce Committee | Sep 23, 2011 |
| S. Hrg. 112-866 | SECURING THE PHARMACEUTICAL SUPPLY CHAIN94 pages | Health, Education, Labor, and Pensions Committee | Sep 14, 2011 |
CRS reports 1
Congressional Research Service work that CRS links to this bill or the law it became, newest first.
Cite it 1
Products on other subjects that cite it, usually among other measures.
| Product | Title | Kind | Published |
|---|---|---|---|
| R42564 | FDA User Fees and the Regulation of Drugs, Biologics, and Devices: Comparative Analysis of S. 3187 and H.R. 5651 Archived | Report | Jun 26, 2012 |
Titles 2
Every title it has carried, official and short, at each stage.
- Official Title as Introduced
- To amend the Federal Food, Drug, and Cosmetic Act to provide the Food and Drug Administration with improved capacity to prevent drug shortages.
- Short Titles as Introduced
- Preserving Access to Life-Saving Medications Act of 2011
Subjects
Assigned by the Library of Congress. Policy area: Health.
Text 1
Each version as it was printed, newest first.
- Jun 21, 2011Introduced in House
Everything here is as published by Congress: the summary is the Congressional Research Service's, the action wording is the clerks', and the subjects are the Library of Congress's. How far it got is read from the actions themselves, taking the most recent one of each kind, so a bill that failed a vote and later passed is shown as having passed. Records come from this bill on Congress.gov and govinfo.gov; cost estimates are the Congressional Budget Office's, and the hearings are the printed hearings GovInfo publishes, which can appear months after the hearing.
