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HR 4408 118th Congress House Health Administrative law and regulatory procedures Civil actions and liability Congressional oversight Department of Health and Human Services Drug safety, medical device, and laboratory regulation Health information and medical records Prescription drugs

Promising Pathway Act

Introduced: June 30, 2023 See on congress.gov
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This bill died when the 118th Congress ended
It never became law before the 118th Congress (2023–2024) adjourned, and bills don't carry over to the next Congress. It would have to be reintroduced. You can still save it for reference, but it won't receive updates.
 Everywhere this bill has been 3 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Jul 7, 2023
Referred to the Subcommittee on Health.
Jun 30, 2023
Referred to the House Committee on Energy and Commerce.
Jun 30, 2023
Introduced in House
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 Plain-English summary Congressional Research Service

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. 

 

What's happening now July 7, 2023

Referred to the Subcommittee on Health.

 Related & companion bills 1
  • S 1906 Identical bill Promising Pathway Act
 Bill text 1 version

Source documents hosted by congress.gov.

 Committees of jurisdiction 2
 Lobbying activity 1

Registered lobbyists who named this bill in their disclosure filings. Source: federal Lobbying Disclosure Act filings.

 Cosponsors 9
All 9 Democratic 3 Republican 3
Garcia, Mike
· Apr 5, 2024
 D
Frankel, Lois
Florida · Dec 7, 2023
 D
Gottheimer, Josh
New Jersey · Dec 7, 2023
 R
Wilson, Joe
South Carolina · Dec 7, 2023
Phillips, Dean
· Oct 26, 2023
D'Esposito, Anthony
· Aug 8, 2023
 R
Fitzpatrick, Brian K.
Pennsylvania · Jun 30, 2023
 D
Quigley, Mike
Illinois · Jun 30, 2023
 R
Westerman, Bruce
Arkansas · Jun 30, 2023
Cite this page click to expand
APA
U.S. Congress. (2026). H.R. 4408: Promising Pathway Act. 118th Congress. Open America. https://openamerica.io/bill/118-HR-4408/
MLA
"H.R. 4408: Promising Pathway Act." 118th Congress, 2026, Open America, https://openamerica.io/bill/118-HR-4408/.
Bluebook (legal)
H.R. 4408, 118th Cong. (2026), https://openamerica.io/bill/118-HR-4408/.
Markdown link
[H.R. 4408: Promising Pathway Act](https://openamerica.io/bill/118-HR-4408/)
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