Source-linked brief · H.R. 8205 · 119th Congress

Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026

Status as of Oct 27, 2026, 9:15 AM CT
Presented to President on Oct. 26, 2026. Presentment does not establish enactment.

On Oct. 26, Congress formally sent H.R. 8205 to the President. Both chambers passed it by voice vote, the House in July and the Senate in September, so there's no roll call showing how each member voted. Sources: [1], [6]

The bill extends the 2021 ACT for ALS law. That law created NIH grants for research through expanded access, which lets some people with ALS who can't get into clinical trials try experimental drugs, plus FDA research grants and a public-private research partnership.

The law authorized up to $100 million a year for fiscal years 2022 through 2026, which ended Sept. 30, 2026, and it barred new NIH grants on or after that date. The FDA grant and partnership sections have no separate end date.

The bill moves both 2026 dates to 2031 and keeps the authorized ceiling at $100 million a year. That's a cap, not a check: the actual money still has to come through yearly spending bills. Sources: [3], [7]

It also adds some guardrails. When an NIH grant comes up for renewal, the agency has to ask for and review the drug's enrollment, safety and any efficacy data, and grant applicants must commit to promptly reporting new, serious and unexpected safety events in the phase 3 trial.

FDA has to publish a five-year action plan within 18 months. Sources: [3]

The President has 10 days, not counting Sundays, which runs through Nov. 6. He can sign it or veto it. If he does neither, it could become law without his signature.

The exception, a pocket veto, applies only if Congress's adjournment prevents the bill's return. Both chambers met briefly on Oct. 26 and adjourned until Oct. 29. The sources checked here do not settle whether a pocket veto could apply during a break like this. Sources: [9], [10], [11], [12]

Evidence and limits

Two fair perspectives (on the record)

Supporters: the bill's sponsors and committee leaders from both parties. On the House floor on July 20, 2026, sponsor Rep. Mike Quigley (D-IL) said the programs "have helped people living with ALS to access promising therapies" and that Congress has "been able to secure over $350 million in Federal funding for these programs."
Co-lead Rep. Ken Calvert (R-CA), in remarks printed in the same debate, said funding rose from "nearly $30 million" in fiscal 2022 to "$86 million" in fiscal 2025 and that "ALS patients and families are relying on us not to lose momentum."
Energy and Commerce Chair Brett Guthrie (R-KY) and Rep. Diana DeGette (D-CO) also spoke in support. Source: Congressional Record, July 20, 2026, H4652 to H4654. The committee approved the bill 46 to 0 (H. Rept. 119-733). Sources: [5], [4]
Oversight caution: NIH officials, as reported by GAO. GAO's Feb. 4, 2026 review (GAO-26-107691), required by the original law, reported that NIH officials described, among other challenges, two limits in the law's requirements. First, the original law did not require NIH to assess whether a drug might work before funding expanded access, which officials said could lead to continued funding for, and patient exposure to, drugs that may not be effective if grants were renewed.
Second, the requirements that the drug be in a phase 3 trial and that its sponsor be a U.S. small business shrink the pool, so NIH gets few applications and could someday get none.
GAO also found that most funded research is ongoing and "the full effects are not yet known." GAO also reported that NIH planned to weigh renewal applicants' progress, which could include progress toward FDA approval.
Neither the bill nor the committee report cites these GAO findings. The bill does add a renewal review of enrollment, safety and any available efficacy data, and it writes into law that combined phase 2/3 trials can count as phase 3, which NIH told GAO it was already doing. It does not change the small business requirement. Sources: [8], [3]

What the record confirms

H.R. 8205 was presented to the President on Oct. 26, 2026 (BILLSTATUS actions). Sources: [1]
The House passed it by voice vote on July 22, 2026, under suspension of the rules; the Senate passed it without amendment by voice vote on Sept. 28, 2026 (BILLSTATUS; CR S5120). No recorded roll call on passage in either chamber. Sources: [1], [6]
Energy and Commerce ordered it reported 46 to 0 on May 21, 2026 (BILLSTATUS; H. Rept. 119-733). Sources: [1], [4]
Sponsor Rep. Quigley (D-IL), original cosponsor Rep. Calvert (R-CA); 103 cosponsors listed (64 D, 39 R) as of the Oct 27 BILLSTATUS file. Sources: [1]
The enrolled text changes "2026" to "2031" in section 7 of Public Law 117-79, which authorizes "$100,000,000 for each of fiscal years 2022 through" that year, and in the section 2(f) sunset on NIH grants (enrolled bill; PL 117-79). Sources: [3], [7]
The committee report says the ACT for ALS Act "will expire on September 30, 2026." In the statute, the NIH grant sunset and the authorization of appropriations end then. The FDA grant and partnership sections have no end date. Sources: [4], [7]
New requirements: renewal review of enrollment, safety and any efficacy data; prompt reporting of new, serious, unexpected adverse events in the phase 3 trial; phase 3 includes combined phase 2/3 trials that start enrolling within a timeframe the HHS Secretary sets in the grant's terms; FDA action plan within 18 months and a report within 5 years (enrolled bill). Sources: [3]
GAO: NIH and FDA awarded about $276.3 million in FY2022 to FY2025 to implement the act, including some FDA funds from other sources; about 750 people with ALS were expected to get investigational drugs through five NIH grants (GAO-26-107691). Sources: [8]
The committee found no new budget authority, and said a CBO estimate was not available when the report was filed (H. Rept. 119-733). Sources: [4]

What is claimed but not confirmed

Rep. Quigley's "over $350 million in Federal funding" secured since 2021. GAO counts about $276.3 million awarded through FY2025; the two figures measure different things.
GAO's total counts funds awarded in FY2022 to FY2025, including some FDA funds from other sources, while Quigley did not say which years or what kind of funding he meant.
For FY2026, the appropriations explanatory statement lists $90 million for the ACT for ALS Act at NIH alone. Not reconciled. Sources: [5], [8], [13]
Rep. DeGette's statement that the 2021 law "revolutionized the way FDA uses real-world evidence." Sources: [5]
Rep. Calvert's statement that the law "has demonstrably sped infrastructure, access, and targeted progress." GAO reports some benefits (more clinic sites, more collaboration) but says full effects are not yet known. Sources: [5], [8]

What is unknown or not yet decided

Whether the President signs or vetoes it. If he does neither by Nov. 6, it could become law without his signature.
The Constitution's exception is when "the Congress by their Adjournment prevent its Return" (Art. I, sec. 7).
Both chambers met briefly on Oct. 26 and adjourned until Oct. 29. The sources checked here do not settle whether a pocket veto could apply during a break like this. Sources: [9], [10], [11], [12]
How much money Congress will actually provide for FY2027 and later; the bill only authorizes. Sources: [3], [7]
What happens to NIH grant awards in the gap between Sept. 30 and enactment. The record checked does not say. Sources: [3], [7]
No CBO cost estimate is listed in the BILLSTATUS record as of Oct 27, 2026. Sources: [1]
The enrollment timeframe NIH will set for combined phase 2/3 trials, and what FDA's new action plan will contain. Sources: [3]

Official sources

Sources 1–9 were checked in the retained draft on Oct 27, 2026, about 8:57 to 9:00 AM CT. Session and funding references 10–13 were checked later on Oct 27. This is a dated snapshot.

Congress.gov returned 403 during the source check. Action records were read from GovInfo BILLSTATUS. GAO’s funding figures are awards through FY2025, not appropriations or a forecast.