PATH Act

Summary

Promise for Antibiotics and Therapeutics for Health Act or the PATH 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.

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Documents

6 official files

• Reported to Senate (text)

  Reported to Senate · EN · 18 April 2016

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• Reported to Senate (PDF)

  Reported to Senate · EN · 18 April 2016

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• Reported to Senate with amendment(s)

  summary · EN · 18 April 2016

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• Introduced in Senate (text)

  Introduced in Senate · EN · 16 January 2015

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• Introduced in Senate (PDF)

  Introduced in Senate · EN · 16 January 2015

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• Introduced in Senate

  summary · EN · 16 January 2015

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