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# Members of Congress Want Clinical Trial Process Changes
- URL: https://www.fdaweb.com/members-of-congress-want-clinical-trial-process-changes/
- Published: 2020-03-10T12:00:00.000Z
- Updated: 2026-09-14T16:06:25.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146293

A bipartisan group of 41 members of the House and Senate are asking FDA commissioner **Stephen Hahn** to deliver on his commitment to improving the clinical trial process for those with terminal illnesses such as amyotrophic lateral sclerosis (ALS). “Our constituents diagnosed with ALS are eager to see action in this regard,” a 3/6 [letter](https://www.coons.senate.gov/imo/media/doc/ALS%20letter%20final21%20%28003%29.pdf?ref=fdaweb.com) to Hahn says. “We take this opportunity to reiterate our interest in working with you to ensure that those with terminal and rare diseases have trials designed with them in mind and are provided a clear and actionable pathway to access safe, promising therapies.”

The letter reviews progress made in the last decade on potential treatments and therapies for neurological diseases and notes that in 2/2020 Hahn received a letter signed by over 15,000 people affected by ALS asking that he take steps to ensure expeditious clinical trials and a well-functioning expanded access program. “We share the belief that, under your leadership, FDA can meet the needs of the ALS community,” the senators and representatives write. “In our view, that means that FDA will work to ensure that all future ALS clinical trial designs incorporate the provisions included in the recently finalized guidance on ALS treatment development. Further, all future ALS clinical trial designs sanctioned by FDA should examine the appropriateness of participants who receive placebo alone. In addition, future trials should consider whether to involve mechanisms to ensure that expanded access is easily available, as appropriate, to patients seeking treatment.”