ALS Patients Ask FDA To See Risk Their Way

04 Mar 2013

• By Shirley Haley

An FDA panel got an earful on the review and regulation of drugs for amyotrophic lateral sclerosis Feb. 25 during a public hearing convened under the agency’s plan to involve patient networks in the regulatory process, particularly where it concerns lowering barriers to drug development for ALS.

Patients with amyotrophic lateral sclerosis are willing to tolerate a lot more risk than other stakeholders have assumed, advocates argued during a day-long public hearing Feb. 25 where they offered their advice on such topics as the design of clinical trials and access to experimental therapies to treat the aggressive and always-fatal neurodegenerative disease.

The meeting was part of the agency’s move to adopt a more patient-focused view toward drug development. A series of...