Antibiotic Development to Advance Patient Treatment Act of 2013
Latest action · Dec 13, 2013 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.
- IntroducedDec 12, 2013
- Passed HouseNot reached
- Passed SenateNot reached
- To the PresidentNot reached
- Became lawNot reached
Summary
Antibiotic Development to Advance Patient Treatment Act of 2013 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to authorize the Secretary of Health and Human Services (HHS) to approve the use of an antibacterial or antifungal drug that is intended for treatment of a serious or life-threatening disease or condition to treat a limited population of patients for which there is an unmet medical need.
Requires the labeling of such drugs to prominently include in the prescribing information the statement that the drug is indicated for use in a limited and specific population of patients.
Amends the Public Health Service Act to authorize the Secretary to license those antibacterial or antifungal drugs as biological products.
Requires the Secretary, acting through the Director of the Centers for Disease Control and Prevention (CDC), to: (1) monitor the use of antibacterial and antifungal drugs, (2) monitor changes in bacterial and fungal resistance to drugs, and (3) make the information derived from such monitoring available to the public.
Amends the FFDCA to direct the Secretary: (1) to identify upon approval, and subsequently update, susceptibility test interpretive criteria for antibacterial drugs by relying upon preclinical and clinical data, Bayesian and pharmacometric statistical methodologies, and such other confirmatory evidence the Secretary deems necessary; (2) on a quarterly basis, to evaluate new or updated criteria published by a nationally or internationally recognized standard development organization; and (3) to publish on the Food and Drug Administration's (FDA's) website a notice adopting, declining to adopt, or partially adopting such new or updated criteria.
Cosponsors 52
Members who signed on, in the order they did. Signatures ran from Dec 12, 2013 to Nov 20, 2014; 9 are original cosponsors, there from the day it was introduced.
| Seat | Cosponsor | Signed on | |
|---|---|---|---|
| D-CA | Anna G. Eshoo | Original | Dec 12, 2013 |
| D-CO | Diana DeGette | Original | Dec 12, 2013 |
| R-KY | Ed Whitfield | Original | Dec 12, 2013 |
| D-NY | Eliot L. Engel | Original | Dec 12, 2013 |
| D-NC | G. K. Butterfield | Original | Dec 12, 2013 |
| D-TX | Gene Green | Original | Dec 12, 2013 |
| R-VA | H. Morgan Griffith | Original | Dec 12, 2013 |
| R-IL | John Shimkus | Original | Dec 12, 2013 |
| R-TN | Marsha Blackburn | Original | Dec 12, 2013 |
| R-LA | Bill Cassidy | Mar 24, 2014 | |
| D-CA | Doris O. Matsui | Mar 24, 2014 | |
| D-UT | Jim Matheson | Mar 24, 2014 | |
| D-KY | John A. Yarmuth | Mar 24, 2014 | |
| D-GA | John Barrow | Mar 24, 2014 | |
| D-MI | John D. Dingell | Mar 24, 2014 | |
| R-NJ | Leonard Lance | Mar 24, 2014 | |
| R-KS | Mike Pompeo | Mar 24, 2014 | |
| D-NY | Paul Tonko | Mar 24, 2014 | |
| R-TX | Pete Olson | Mar 24, 2014 | |
| R-NC | Renee L. Ellmers | Mar 24, 2014 | |
| R-OH | Robert E. Latta | Mar 24, 2014 | |
| D-NM | Ben Ray Luján | Apr 28, 2014 | |
| R-KY | Brett Guthrie | Apr 28, 2014 | |
| R-FL | Gus M. Bilirakis | May 8, 2014 | |
| D-NH | Carol Shea-Porter | May 28, 2014 | |
| D-CA | Jackie Speier | May 28, 2014 | |
| R-WA | Cathy McMorris Rodgers | Jul 9, 2014 | |
| R-IL | Peter J. Roskam | Jul 10, 2014 | |
| R-TX | Michael T. McCaul | Jul 15, 2014 | |
| D-RI | James R. Langevin | Jul 17, 2014 | |
| R-TX | Joe Barton | Jul 17, 2014 | |
| R-AL | Bradley Byrne | Jul 22, 2014 | |
| R-TN | David P. Roe | Jul 22, 2014 | |
| D-CA | Jerry McNerney | Jul 22, 2014 | |
| D-NJ | Bill Pascrell, Jr. | Jul 29, 2014 | |
| D-TX | Eddie Bernice Johnson | Jul 30, 2014 | |
| R-NV | Joseph J. Heck | Sep 8, 2014 | |
| R-TN | Scott DesJarlais | Sep 9, 2014 | |
| D-WA | Derek Kilmer | Sep 11, 2014 | |
| D-MN | Keith Ellison | Sep 11, 2014 | |
| R-TX | Bill Flores | Sep 15, 2014 | |
| R-TX | K. Michael Conaway | Sep 15, 2014 | |
| R-GA | Austin Scott | Sep 16, 2014 | |
| R-OH | David P. Joyce | Sep 16, 2014 | |
| D-CA | Mark Takano | Sep 16, 2014 | |
| R-CO | Scott R. Tipton | Sep 16, 2014 | |
| D-NY | Yvette D. Clarke | Sep 16, 2014 | |
| D-IL | Bobby L. Rush | Nov 12, 2014 | |
| R-MS | Gregg Harper | Nov 12, 2014 | |
| R-MI | Mike Rogers | Nov 12, 2014 | |
| D-PA | Matt Cartwright | Nov 19, 2014 | |
| D-CA | Julia Brownley | Nov 20, 2014 |
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 Dec 12, 2013 |
| Health Subcommittee | Referred Dec 13, 2013 |
Actions 3
Everything that happened, newest first.
- Dec 13, 2013Referred to the Subcommittee on Health.
- Dec 12, 2013Introduced in House
- Dec 12, 2013Referred to the House Committee on Energy and Commerce.
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.
Printed hearings 1
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. 113-178 | 21ST CENTURY CURES: EXAMINING WAYS TO COMBAT ANTIBIOTIC RESISTANCE AND FOSTER NEW DRUG DEVELOPMENT217 pages | Energy and Commerce Committee | Sep 19, 2014 |
Titles 2
Every title it has carried, official and short, at each stage.
- Official Title as Introduced
- To provide for approval of certain drugs and biological products indicated for use in a limited population of patients in order to address increases in bacterial and fungal resistance to drugs and biological products, and for other purposes.
- Short Titles as Introduced
- Antibiotic Development to Advance Patient Treatment Act of 2013
Subjects
Assigned by the Library of Congress. Policy area: Health.
- Administrative law and regulatory procedures
- Administrative remedies
- Consumer affairs
- Department of Health and Human Services
- Drug safety, medical device, and laboratory regulation
- Food and Drug Administration (FDA)
- Government information and archives
- Health
- Health information and medical records
- Infectious and parasitic diseases
- Licensing and registrations
- Medical research
- Prescription drugs
Text 1
Each version as it was printed, newest first.
- Dec 12, 2013Introduced 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.
