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# Senators Introduce Bipartisan Bill on Expanded Access
- URL: https://www.fdaweb.com/senators-introduce-bipartisan-bill-on-expanded-access/
- Published: 2017-05-08T12:00:00.000Z
- Updated: 2026-09-14T22:22:18.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138631

U.S. Senators **Michael Bennet** (D-CO), **Orrin Hatch** (R-UT), **Richard Burr** (R-NC), and **Bob Casey** (D-PA) have introduced legislation to improve clinical trials for experimental treatments that have life-saving potential. “The current clinical trial process is outdated, preventing the FDA and drug manufacturers from developing critical treatments for patients who need them most,” **Bennet said**. “This legislation will provide needed direction to improve clinical trials by expanding eligibility to high-risk patients. It will also create a more streamlined and transparent process for patients who still don't qualify for a clinical trial, but need access to experimental treatments.” According to the lawmakers, [the bill](https://www.bennet.senate.gov/?p=release&id=3901&ref=fdaweb.com) would: 

- Authorize a public meeting between FDA and NIH to discuss clinical trial criteria
- Require the Government Accountability Office to study the challenges of expanding clinical trials and provide recommendations
- Improve the institutional review board assessment of individual pediatric and adult patient expanded access protocols
- Allow drug manufacturers and sponsors to make their expanded access policies available during Phase 1 studies, rather later Phase 2 or 3 studies, for drugs going through the breakthrough therapy, fast track product, or regenerative advanced therapy pathways.