United StatesBill would move ALS therapy law dates from 2026 to 2031
The measure would move two dates from 2026 to 2031, add ALS grant review and safety steps, and require an FDA action plan.
What it does
Two parts of the ALS therapies law would use 2031 instead of 2026, including the provision covering research grants.
For renewals involving an experimental ALS drug, the Secretary would assess enrollment, safety, and available effectiveness data. Grant seekers would promptly report certain serious safety problems.
Within 18 months after enactment, FDA would publish a five-year action plan. Within five years after enactment, it would report its actions and how fully the plan met the stated requirements.
Argument forSetting 2031 dates could support continuity for covered ALS research grants, while public FDA plans and reports may make agency work easier to track.
Argument againstExtra data reviews and prompt safety reports could increase work for drug sponsors and grant applicants, especially during ongoing trials.
More detail
The measure would replace 2026 with 2031 in two cited parts of the ALS therapies law. The date replacements cover section 7 of that law and its ALS research grant provision.
The Secretary would review specified renewal data, and grant seekers would report certain safety problems. The renewal review applies to grants involving an experimental drug for preventing, diagnosing, easing, treating, or curing ALS. A grant seeker would promptly report new and serious adverse events and unexpected safety information from the phase 3 trial, in addition to following existing federal safety reporting rules. A combined phase 2/3 trial would count as phase 3 only if enrollment begins within the timeframe the Secretary sets in the grant terms.
The FDA Commissioner would publish an action plan and a follow-up report online. The plan would describe FDA actions for the five years after publication involving program improvements, policy development, regulatory science, and related initiatives listed in the law. Both the action plan and the follow-up report would have to appear on the FDA website. The plan would be due within 18 months after enactment, and the follow-up report would be due within five years after enactment.
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Where it stands
- Introduced
- Passed House
- Passed Senate
- To President
- Became Law
Looking ahead
No hearings or votes scheduled.
History
- 2026
- Oct 26Presented to President.To President
- Oct 14Message on Senate action sent to the House.
- Sep 28Passed/agreed to in Senate: Passed Senate without amendment by Voice Vote. (consideration: CR S5120)Passed Senate
- Jul 23Received in the Senate. Read twice. Placed on Senate Legislative Calendar under General Orders. Calendar No. 466.
- Jul 22Considered as unfinished business. (consideration: CR H5159)
- Jul 22Passed/agreed to in House: On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote.Passed House
- Jul 22Motion to reconsider laid on the table Agreed to without objection.
- Jul 20Mr. Guthrie moved to suspend the rules and pass the bill, as amended.
- Jul 20Considered under suspension of the rules. (consideration: CR H4652-4654; text: CR H4653)
- Jul 20DEBATE - The House proceeded with forty minutes of debate on H.R. 8205.
- Jul 20At the conclusion of debate, the chair put the question on the motion to suspend the rules. Mr. Guthrie objected to the vote on the grounds that a quorum was not present. Further proceedings on the motion were postponed. The point of no quorum was considered as withdrawn.
- Jul 9Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 119-733.
- Jul 9Placed on the Union Calendar, Calendar No. 637.
- May 21Committee Consideration and Mark-up Session Held
- May 21Ordered to be Reported (Amended) by the Yeas and Nays: 46 - 0.
- May 13Subcommittee Consideration and Mark-up Session Held
- May 13Forwarded by Subcommittee to Full Committee by Voice Vote.
- Apr 6Introduced in House
- Apr 6Referred to the House Committee on Energy and Commerce.
- Apr 6Referred to the Subcommittee on Health.Introduced
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