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# House Bill on Provisional Drug Approvals
- URL: https://www.fdaweb.com/house-bill-on-provisional-drug-approvals/
- Published: 2023-06-30T12:00:00.000Z
- Updated: 2026-09-14T18:42:24.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154811

A group of bipartisan House members are reintroducing the Promising Pathway Act that would provide a provisional approval pathway for promising drugs that treat life-threatening conditions. “Although other expedited pathways exist, this bill allows for more innovative clinical trials and encourages FDA review of applications on a rolling basis,” a [news release](https://gallagher.house.gov/media/press-releases/gallagher-colleagues-reintroduce-promising-pathway-act-1?ref=fdaweb.com#:~:text=The%20Promising%20Pathway%20Act%20would,showing%20significant%20evidence%20of%20effectiveness.) says. “To gain FDA approval through this pathway, drug sponsors still need to demonstrate substantial evidence of safety and early evidence of effectiveness. Provisional approval can only last up to eight years so sponsors are incentivized to pursue full FDA approval.”

The measure is being introduced by Reps. **Mike Gallagher** (R-WI), **Mike Quigley** (D-IL), **Bruce Westerman** (R-AR), and **Eric Swalwell** (D-CA). To view the bill text, Click [here**.**](https://urldefense.com/v3/%5F%5Fhttps:/r20.rs6.net/tn.jsp?f=001dJ4RKcvpUVZ1XaslQr%5F7U6rTbM0k7CvlNAI3bfIoVzN0swhGuwRwzAjAr1SxIHv70LT4zHD6iJqMxBgi8Dt0LPHSYXU4R5EeOD4plCSMI7VTVaJkENxF0X6T-L5pkvkvB5446YVMLEryW4F4qdAZg2yaZwzPvBINkjhcj81WWaiM4dUO57-aGPWm9YV6cv1JLAgJA8mkLcAOD2WikDvC7AfuqYDEBF%5FqixB2miV2lHA=&c=K5P4YAr14UyaKd1HjK8jbGfEoorhqFdvAJxRWr8gcpc4kdgSjhpBeA==&ch=0xY9D-50qsV2B4QxZ7bmAMJjjqW%5FCIfwW4XXTLPRuC45bHLHA0-ijQ==%5F%5F;!!Bg5easoyC-OII2vlEqY8mTBrtW-N4OJKAQ!IfOtXuFA2eAgLiIGgr4eWRVd8-k9-9p9abzqmEIDTkndJxt%5Fe9dA2jCiWoi6Pb8Wgdjdn9Mpqqz42j6rPpvIsJ7v0BMTCXKi8lEDmfn69naNdgQUNUN6ZFY%24&ref=fdaweb.com)