Senate-passed bill would update the ALS therapy access law for 2027 through 2031

The bill would change the years covered by section 7 of the ALS access law from 2022 through 2026 to 2027 through 2031, and the end year for ALS research grants from 2026 to 2031. It covers the Accelerating Access to Critical Therapies for ALS Act. The text does not show what section 7 provides, such as funding amounts.

Applicants for expanded access grants would have to describe how data from the grant will support ALS research, and promise to promptly report safety data from any ongoing clinical trial of the drug. Renewals would require the grant sponsor's enrollment, safety, and any efficacy data to be requested and assessed. A phase 3 trial would include a combined phase 2/3 trial and a planned phase 3 trial not yet enrolling.

The FDA would develop or update its action plan for rare neurodegenerative diseases within 1 year after the bill becomes law and every 5 years after, and new plans would describe past actions, planned actions, and barriers. The Secretary of Health and Human Services would also report to the House and Senate health committees on how well the grants and related activities work. The Health and Human Services report is due within 4 years after the bill becomes law.