PATH Act Promise for Antibiotics and Therapeutics for Health Act
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S 185 — PATH Act Promise for Antibiotics and Therapeutics for Health Act
Last action — Placed on Senate Legislative Calendar under General Orders. Calendar No. 425.
No card. One bill, free forever — alerts when it moves.
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✓Introduced
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Died in session
This bill died with 114th Congress. It reached “Introduced” 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This bill is no longer active — its legislative session has ended, so there is no live prognosis.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
PATH Act Promise for Antibiotics and Therapeutics for Health Act Amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to establish a program to approve as a limited population antibacterial drug an antibacterial drug intended to treat a serious medical condition and to address an unmet medical need within an identifiable limited population. Requires the FDA's determination of the safety and effectiveness of these drugs to reflect the drug's benefit-risk profile in the intended limited population. Prohibits the FDA from denying approval of a drug based on a lack of evidence of a favorable benefit-risk profile in a broader population. Directs the FDA to require: (1) the labeling of a limited population antibacterial drug to indicate that the drug has been approved for use only in a limited population, and (2) submission of promotional materials related to the drug prior to dissemination. Directs the FDA to describe considerations for demonstrating the safety and effectiveness of these antibacterial drugs and how the limited population pathway can be expanded to other therapeutic areas. Requires the FDA to conduct post-approval monitoring programs to study how these antibacterial drugs are used and to monitor changes in bacterial drug resistance. Allows the FDA to remove the labeling, marketing, and post-approval monitoring requirements of these drugs if they are approved for broader use. Allows the limited population pathway to be expanded to other drugs intended to treat serious illness beginning October 1, 2016.
Bill Text
We don't have the full text on file for this bill yet.
Read S 185 on the official United States source →Action History
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Placed on Senate Legislative Calendar under General Orders. Calendar No. 425.
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Committee on Health, Education, Labor, and Pensions. Reported by Senator Alexander with an amendment in the nature of a substitute. Without written report.
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Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
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Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Sponsors
- Orrin Hatch · 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 S 185 do?
- PATH Act Promise for Antibiotics and Therapeutics for Health Act Amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to establish a program to approve as a limited population antibacterial drug an antibacterial drug intended to treat a serious medical condition and to address an unmet medical need within an identifiable limited population. Requires the FDA's determination of the safety and effectiveness of these drugs to reflect the drug's benefit-risk profile in the intended limited population. Prohibits the FDA from denying approval of a drug based on a lack of evidence of a favorable benefit-risk profile in a broader population. Directs the FDA to require: (1) the labeling of a limited population antibacterial drug to indicate that the drug has been approved for use only in a limited population, and (2) submission of promotional materials related to the drug prior to dissemination. Directs the FDA to describe considerations for demonstrating the safety and effectiveness of these antibacterial drugs and how the limited population pathway can be expanded to other therapeutic areas. Requires the FDA to conduct post-approval monitoring programs to study how these antibacterial drugs are used and to monitor changes in bacterial drug resistance. Allows the FDA to remove the labeling, marketing, and post-approval monitoring requirements of these drugs if they are approved for broader use. Allows the limited population pathway to be expanded to other drugs intended to treat serious illness beginning October 1, 2016.
- Who sponsors S 185?
- S 185 is sponsored by Orrin Hatch (R).
- What is the current status of S 185?
- This bill died with 114th Congress. It reached “Introduced” 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 S 185?
- Track S 185 free on One Click Politics — get push/email alerts when it moves.
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