H.R. 4408 · 118th Congress
Promising Pathway Act
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Never voted on. It didn't reach a floor vote before the 118th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.
R
GallagherSponsor10 cosponsors · 5 D, 5 R
R
Fitzpatrick
MQ
D
Quigley
ES
D
Swalwell
BW
R
Westerman
AD
R
D'Esposito
DP
D
Phillips
LF
D
Frankel
JG
D
Gottheimer
JW
R
Wilson
MG
R
Garcia4 signed on when it was introduced; the rest joined later. Cosponsors who withdrew aren't shown.
This bill provides for expedited, provisional approval of drugs for serious or life-threatening diseases or conditions.
What it does: CRS summary · Introduced in House · Jun 30, 2023
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.
Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov
About this bill and sources
Official title: Promising Pathway Act
Latest action (Jul 7, 2023): Referred to the Subcommittee on Health.
Policy area: Health · Origin: House · Introduced: Jun 30, 2023
Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)
No recorded floor vote found.