US SB185 | 2015-2016 | 114th Congress
Status
Spectrum: Bipartisan Bill
Status: Introduced on January 16 2015 - 25% progression, died in chamber
Action: 2016-04-18 - Placed on Senate Legislative Calendar under General Orders. Calendar No. 425.
Text: Latest bill text (Introduced) [PDF]
Status: Introduced on January 16 2015 - 25% progression, died in chamber
Action: 2016-04-18 - Placed on Senate Legislative Calendar under General Orders. Calendar No. 425.
Text: Latest bill text (Introduced) [PDF]
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.
Title
PATH Act Promise for Antibiotics and Therapeutics for Health Act
Sponsors
| Sen. Orrin Hatch [R-UT] | Sen. Michael Bennet [D-CO] | Sen. Kelly Ayotte [R-NH] | Sen. Johnny Isakson [R-GA] |
| Sen. Mark Kirk [R-IL] | Sen. Thomas Carper [D-DE] | Sen. Richard Blumenthal [D-CT] |
History
| Date | Chamber | Action |
|---|---|---|
| 2016-04-18 | Senate | Placed on Senate Legislative Calendar under General Orders. Calendar No. 425. |
| 2016-04-18 | Senate | Committee on Health, Education, Labor, and Pensions. Reported by Senator Alexander with an amendment in the nature of a substitute. Without written report. |
| 2016-04-06 | Senate | Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably. |
| 2015-01-16 | Senate | Read twice and referred to the Committee on Health, Education, Labor, and Pensions. |
Subjects
Administrative law and regulatory procedures
Department of Health and Human Services
Drug safety, medical device, and laboratory regulation
Drug therapy
Food and Drug Administration (FDA)
Health
Department of Health and Human Services
Drug safety, medical device, and laboratory regulation
Drug therapy
Food and Drug Administration (FDA)
Health
