S 3872
Promising Pathway Act
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Sign in to take action- Introduced
- Passed Senate
- Passed House
- To President
- Became Law
Bill overview
The Promising Pathway Act creates a faster approval process for certain medicines intended to treat serious or life-threatening diseases, including those related to epidemics and pandemics. Drugs receiving this ‘provisional approval’ can be reviewed on a rolling basis, potentially shortening the time to market. Manufacturers must require patient participation in observational registries and face potential penalties for non-compliance, and the FDA has the authority to withdraw approval if safety concerns arise. The bill also includes provisions to encourage the use of real-world evidence and limits liability for manufacturers of these drugs.
Sponsors
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Primary sponsor
Mike Braun
Cosponsors
David Perdue
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