Promising Pathway Act

Summary

Promising Pathway Act  This bill provides for expedited, provisional approval of drugs for serious or life-threatening diseases or conditions. Specifically, the bill allows for provisional approval of drugs that are used to treat, prevent, or diagnose a serious or life-threatening disease or condition for which premature death is likely without early medical intervention. The Food and Drug Administration (FDA) must evaluate applications within 90 days of receipt. The FDA may approve applications if there is early evidence, including real-world and real-time evidence, of the drug's efficacy, as well as substantial evidence of the drug's safety. Provisional approval is valid for two years and may be renewed for up to eight years. The FDA may withdraw provisional approval in the event of serious adverse health effects.  Drug sponsors that receive provisional approval must require all patients receiving the drug to participate in an observational registry, through which the drug sponsor may collect and submit data relating to the drug until it is fully approved. Registries may be operated by the drug sponsor or another entity. The FDA must annually review these registries; sponsors of registries that fail to meet the bill's requirements are subject to civil penalties.   

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Timeline

1. 8 June 2023

   Introduced

   Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

   Source: IntroReferral

2. 8 June 2023

   Introduced

   Introduced in Senate

   Source: IntroReferral

Votes

No vote records are attached yet.

Versions

• Introduced in Senate · 8 June 2023 · Official file

Documents

3 official files

• Introduced in Senate (text)

  Introduced in Senate · EN · 8 June 2023

  ViewDownloadOpen at official source

• Introduced in Senate (PDF)

  Introduced in Senate · EN · 8 June 2023

  ViewDownloadOpen at official source

• Introduced in Senate

  summary · EN · 8 June 2023

  Open at official source

Sponsors

• Sen. Braun, Mike [R-IN] · R · Sponsor
• Kirsten Gillibrand · D · Sponsor
• Roger Wicker · R · Sponsor
• Kevin Cramer · R · Sponsor
• Lisa Murkowski · R · Sponsor
• Sen. Manchin, Joe, III [I-WV] · D · Cosponsor
• Sen. Warnock, Raphael G. [D-GA] · D · Cosponsor
• Sen. Vance, J. D. [R-OH] · R · Cosponsor
• Eric Schmitt · R · Cosponsor
• Sen. Graham, Lindsey [R-SC] · R · Cosponsor
• Jeanne Shaheen · D · Cosponsor
• Sen. Padilla, Alex [D-CA] · D · Cosponsor
• Cynthia Lummis · R · Cosponsor
• Pete Ricketts · R · Cosponsor
• Steve Daines · R · Cosponsor
• Shelley Capito · R · Cosponsor
• Sen. Tester, Jon [D-MT] · D · Cosponsor
• Peter Welch · D · Cosponsor
• John Fetterman · D · Cosponsor
• John Kennedy · R · Cosponsor
• · sshr00 · Standing

Related records

• related to ← Promising Pathway Act