Antibiotic Development to Advance Patient Treatment Act
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HR 2629 — Antibiotic Development to Advance Patient Treatment Act
Last action — Referred to the Subcommittee on Health.
No card. One bill, free forever — alerts when it moves.
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✓Introduced
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✓In Committee
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Died in session
This bill died with 114th Congress. It reached “In Committee” and never advanced before the session ended, so it can no longer move — a new version would have to be reintroduced in the current session.
This bill is no longer active — its legislative session has ended, so there is no live prognosis. It would have to be reintroduced in the current session to move again.
Summary
Antibiotic Development to Advance Patient Treatment Act This bill amends the Federal Food, Drug, and Cosmetic Act to allow the Food and Drug Administration (FDA) to agree with the sponsor of an applicable medication on a process for approving the medication for use in a limited population of patients. Applicable medications are antibacterial or antifungal drugs or biological products for the treatment of a serious infection. The FDA may rely on alternate study endpoints, limited data sets, and additional data, including preclinical evidence, in approving such a medication. A medication approved for use in a limited population must be labeled accordingly. The Public Health Service Act is amended to require the Department of Health and Human Services to monitor the use of antibacterial and antifungal medications and monitor antibacterial and antifungal resistance. (An individual infected by a strain of bacteria or fungi that is resistant to a medication cannot be treated with that medication. Resistance can develop naturally with the use of a medication.) The FDA must identify and publish susceptibility test interpretive criteria for antimicrobial medications. (These criteria are used to characterize the resistance of microbes to antimicrobial medications. "Microbes" or "microorganisms" include bacteria, some fungi, and other organisms.) Every six months, the FDA must evaluate any new or updated susceptibility test interpretive criteria established by a standard development organization and recognize new criteria or withdraw recognition of criteria, as appropriate. The FDA may allow marketing of medical devices that use these criteria without premarket approval.
Bill Text
We don't have the full text on file for this bill yet.
Read HR 2629 on the official United States source →Action History
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Referred to the Subcommittee on Health.
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Referred to the House Committee on Energy and Commerce.
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Introduced in House
Sponsors
- John Shimkus · Primary
Sponsorship breakdown
Export CSV (upgrade) →1 sponsors · 0 co-sponsors · 546 not signed on
Sponsors (1)
Co-sponsors (0)
None.
Not signed on (546)
546 members have not signed on to this bill.
Show all 546 →"Not signed on" means a member has not sponsored or co-sponsored this bill — it does not imply opposition. Members flagged Voted No have a recorded No vote on this bill.
Subjects
Frequently asked questions
- What does HR 2629 do?
- Antibiotic Development to Advance Patient Treatment Act This bill amends the Federal Food, Drug, and Cosmetic Act to allow the Food and Drug Administration (FDA) to agree with the sponsor of an applicable medication on a process for approving the medication for use in a limited population of patients. Applicable medications are antibacterial or antifungal drugs or biological products for the treatment of a serious infection. The FDA may rely on alternate study endpoints, limited data sets, and additional data, including preclinical evidence, in approving such a medication. A medication approved for use in a limited population must be labeled accordingly. The Public Health Service Act is amended to require the Department of Health and Human Services to monitor the use of antibacterial and antifungal medications and monitor antibacterial and antifungal resistance. (An individual infected by a strain of bacteria or fungi that is resistant to a medication cannot be treated with that medication. Resistance can develop naturally with the use of a medication.) The FDA must identify and publish susceptibility test interpretive criteria for antimicrobial medications. (These criteria are used to characterize the resistance of microbes to antimicrobial medications. "Microbes" or "microorganisms" include bacteria, some fungi, and other organisms.) Every six months, the FDA must evaluate any new or updated susceptibility test interpretive criteria established by a standard development organization and recognize new criteria or withdraw recognition of criteria, as appropriate. The FDA may allow marketing of medical devices that use these criteria without premarket approval.
- Who sponsors HR 2629?
- HR 2629 is sponsored by John Shimkus (R).
- What is the current status of HR 2629?
- This bill died with 114th Congress. It reached “In Committee” and never advanced before the session ended, so it can no longer move — a new version would have to be reintroduced in the current session.
- Where can I track HR 2629?
- Track HR 2629 free on One Click Politics — get push/email alerts when it moves.
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Last checked for changes about 11 hours ago · updated continuously
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