HR 4408 · 118th Congress 2023–2025, ended

Promising Pathway Act

Introduced Jun 30, 2023 Originated House Sponsor Mike Gallagher R-WI

Fact sheet

Latest action · Jul 7, 2023 Referred to the Subcommittee on Health.

Progress

Where this bill reached, and when. A stage with no date was not reached; one that failed a vote and later carried shows the date it carried.

  1. IntroducedJun 30, 2023
  2. Passed HouseNot reached
  3. Passed SenateNot reached
  4. To the PresidentNot reached
  5. Became lawNot reached

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. 

 

Cosponsors 10

Members who signed on, in the order they did. Signatures ran from Jun 30, 2023 to Apr 5, 2024, with 4 there on the day it was introduced.

SeatCosponsorSigned on
R-PABrian K. FitzpatrickOriginalJun 30, 2023
R-ARBruce WestermanOriginalJun 30, 2023
D-CAEric SwalwellOriginalJun 30, 2023
D-ILMike QuigleyOriginalJun 30, 2023
R-NYAnthony D'EspositoAug 8, 2023
D-MNDean PhillipsOct 26, 2023
R-SCJoe WilsonDec 7, 2023
D-NJJosh GottheimerDec 7, 2023
D-FLLois FrankelDec 7, 2023
R-CAMike GarciaApr 5, 2024

Actions 3

Everything that happened, newest first.

  1. Jul 7, 2023Referred to the Subcommittee on Health.
  2. Jun 30, 2023Introduced in House
  3. Jun 30, 2023Referred to the House Committee on Energy and Commerce.

Related bills 1

Companion bills and other measures the record links to this one.

BillTitleRelationshipLatest action
S 1906Promising Pathway ActIdentical billJun 8, 2023

Subjects

Assigned by the Library of Congress. Policy area: Health.

Text 1

Each version as it was printed, newest first.

  1. Jun 30, 2023Introduced in House

Support LegiList

This page is free, carries no paywall, and is built and maintained by one person. If the record here is useful to you, a few dollars keeps it going.

$1 $5 $10

Processed by Stripe in a separate window. LegiList never sees card details.

Everything here is as published by Congress: the summary is the Congressional Research Service's, the action wording is the clerks', and the subjects are the Library of Congress's. How far it got is read from the actions themselves, taking the most recent one of each kind, so a bill that failed a vote and later passed is shown as having passed. Records come from this bill on Congress.gov and govinfo.gov.