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S. 1644 117th Congress Senate

Promising Pathway Act

Official title: A bill to amend the Federal Food, Drug, and Cosmetic Act to establish a time-limited provisional approval pathway, subject to specific obligations, for certain… Show full official titleShow less

Official title: A bill to amend the Federal Food, Drug, and Cosmetic Act to establish a time-limited provisional approval pathway, subject to specific obligations, for certain drugs and biological products, and for other purposes.

Introduced: June 22, 2021 See on congress.gov
Health Cardiovascular and respiratory healthCivil actions and liabilityCongressional oversightDrug safety, medical device, and laboratory regulation
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Drug therapyEmergency medical services and trauma careEmployee benefits and pensionsGovernment information and archivesGovernment studies and investigationsHealth care costs and insuranceHealth care coverage and accessHealth information and medical recordsImmunology and vaccinationInfectious and parasitic diseasesLicensing and registrationsManufacturingMedical researchMedical tests and diagnostic methodsPrescription drugsScientific communication
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This bill died when the 117th Congress ended
It never became law before the 117th Congress (2021–2022) 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 2 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
May 13, 2021
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
May 13, 2021
Introduced in Senate
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 Latest action May 13, 2021

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

 Plain-English summary Congressional Research Service

Promising Pathway Act

This bill establishes a provisional approval pathway for medicines intended for serious or life-threatening diseases, including illnesses posing a threat of epidemic or pandemic. The period of the provisional approval is for two years and is potentially renewable.

The Food and Drug Administration (FDA) must establish a priority review system to evaluate completed provisional approval applications within 90 days of receipt. A provisional approval application may be approved if the FDA determines that (1) there is substantial evidence of safety for the drug; and (2) there is relevant early evidence of efficacy, based on adequate and well-controlled investigations.

During the COVID-19 (i.e., coronavirus disease 2019) pandemic, or another epidemic or pandemic, the FDA must accept and review various portions of a provisional approval application on a rolling basis.

The manufacturer of a provisionally approved drug must require patients to participate in an observational registry. A manufacturer that fails to comply with registry requirements is subject to civil penalties.

A provisionally approved drug must be labeled as such.

If a drug that receives provisional approval status is not brought to market within 180 days of the approval, the approval must be rescinded.

The bill also limits the liability of a manufacturer of a provisionally approved drug with respect to any claim under state law alleging that the drug is unsafe or ineffective.

Private health insurers and federal health care programs shall not deny coverage of a provisionally approved drug on the basis of it being experimental.

 Related & companion bills 2
  • HR 3761 Identical bill Promising Pathway Act
  • HR 8588 Fair Care Act of 2022
 Bill text 1 version

Source documents hosted by congress.gov.

 Committees of jurisdiction 1
 Lobbying activity 2

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

Bodies those filers lobbied

A filing lists the bills it worked on and the parts of government it contacted in separate sections, so these are the bodies those filers named anywhere in the filing, not a per-bill breakdown.

 Cosponsors 6
All 6 Republican 6
R
Risch, James E.
Idaho · Mar 10, 2022
 R
Collins, Susan M.
Maine · Jun 22, 2021
 R
Boozman, John
Arkansas · May 20, 2021
 R
Cramer, Kevin
North Dakota · May 13, 2021
 R
Murkowski, Lisa
Alaska · May 13, 2021
 R
Wicker, Roger F.
Mississippi · May 13, 2021
Cite this page click to expand
APA
U.S. Congress. (2026). S. 1644: Promising Pathway Act. 117th Congress. Open America. https://openamerica.io/bill/117-S-1644/
MLA
"S. 1644: Promising Pathway Act." 117th Congress, 2026, Open America, https://openamerica.io/bill/117-S-1644/.
Bluebook (legal)
S. 1644, 117th Cong. (2026), https://openamerica.io/bill/117-S-1644/.
Markdown link
[S. 1644: Promising Pathway Act](https://openamerica.io/bill/117-S-1644/)
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