Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026

This Act may be cited as the Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026.
Section 7 of the Accelerating Access to Critical Therapies for ALS Act (Public Law 117–79) is amended by striking 2026 and inserting 2031.
Section 2(f) of the Accelerating Access to Critical Therapies for ALS Act (21 U.S.C. 360ee note) is amended by striking 2026 and inserting 2031.
Section 2(b) of the Accelerating Access to Critical Therapies for ALS Act (21 U.S.C. 360ee note) is amended by adding at the end the following:
In reviewing applications for renewals of a grant awarded under this section with respect to an investigational drug, the Secretary shall assess the status of a clinical trial carried out for such drug with respect to data on enrollment of patients in such clinical trial.
To enable the Secretary to make the assessment under subparagraph (A) with respect to an investigational drug, the Secretary shall request that the manufacturer of the investigational drug share interim clinical trial data with respect to such drug with the Secretary.
Section 2(e) of the Accelerating Access to Critical Therapies for ALS Act (21 U.S.C. 360ee note) is amended by adding at the end the following:
The term phase 3, with respect to a clinical trial, includes a phase 2/3 combined trial and a planned phase 3 clinical trial that is not yet enrolling participants.
Section 4 of the Accelerating Access to Critical Therapies for ALS Act (21 U.S.C. 360aa note) is amended by adding at the end the following:
Not later than one year after the date of enactment of the Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026, the Commissioner of Food and Drugs shall publish on the website of the Food and Drug Administration a report that contains—
an updated action plan, including—
a description of the actions the Food and Drug Administration intends to take during the 5-year period following publication of the plan with respect to the program enhancements, policy development, regulatory science initiatives, and other appropriate initiatives described in subsection (a);
a description of the resources necessary to implement each section of the plan within such 5-year period; and
specific approaches the Commissioner will take to improve coordination of implementation of the plan with rare neurodegenerative disease communities that are not specifically ALS communities; and
with respect to the Action Plan for Rare Neurodegenerative Diseases including Amyotrophic Lateral Sclerosis (ALS) published by the Food and Drug Administration on June 23, 2022 (referred to in this section as the 2022 Action Plan), a description of—
the actions taken by the Food and Drug Administration under the 2022 Action Plan;
the effect of the implementation of the 2022 Action Plan on the development of therapies and regulatory consideration of therapies for ALS and other rare neurodegenerative diseases;
any programs and initiatives that established or carried out as part of the implementation of the 2022 Action Plan; and
the extent to which the 2022 Action Plan was implemented with respect to rare neurodegenerative diseases that are not amyotrophic lateral sclerosis.
Section 6 of the Accelerating Access to Critical Therapies for ALS Act (Public Law 117–79) is amended, in the matter preceding paragraph (1)—
by striking 4 years after the date of the enactment of this Act and inserting 5 years after the date of enactment of the Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026; and
by inserting , with respect to the 10-year period starting on the date of enactment of this Act after containing.
This Act may be cited as the Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026.
Section 7 of the Accelerating Access to Critical Therapies for ALS Act (Public Law 117–79) is amended by striking 2022 through 2026 and inserting 2027 through 2031.
Section 2(f) of the Accelerating Access to Critical Therapies for ALS Act (21 U.S.C. 360ee note) is amended by striking 2026 and inserting 2031.
Section 2 of the Accelerating Access to Critical Therapies for ALS Act (21 U.S.C. 360ee note) is amended—
in subsection (a), by inserting (referred to in this section as expanded access grants) before the period at the end of the first sentence;
in subsection (b)—
by striking (b) Application— and all that follows through A participating in paragraph (1) and inserting the following:
A participating
by redesignating paragraphs (2) and (3) as paragraphs (1) and (2) respectively;
in the matter preceding paragraph (1), as so redesignated, by striking the period at the end and inserting including—;
by amending paragraph (1), as so redesignated, to read as follows:
a description of how data generated through the proposed expanded access grant will be used to support research or development related to the prevention, diagnosis, mitigation, treatment, or cure of amyotrophic lateral sclerosis;
in paragraph (2), as so redesignated—
by striking Noninterference with clinical trials— and all that follows through shall include;
by striking program and inserting grant; and
by striking the period at the end and inserting ; and; and
by adding at the end the following:
an assurance that such entity will promptly report to the Secretary available safety data from any ongoing clinical trial of the investigational drug as set forth in the terms and conditions of the grant.
in subsection (c)—
by redesignating subparagraphs (A) and (B) of paragraph (2) as clauses (i) and (ii), respectively, and adjusting the margins accordingly;
by redesignating paragraphs (1) through (3) as subparagraphs (A) through (C), respectively, and adjusting the margins accordingly;
in subparagraph (C), as so redesignated, by striking the period at the end and inserting ; and;
in the matter preceding subparagraph (A), as so redesignated, by striking this section, confirm that— and inserting the following: “this section—
confirm that—
by adding at the end the following:
in the case of a renewal of such a grant, request from the sponsor of the investigational new drug application involved, and assess, the enrollment, safety, and any available efficacy data of the drug related to the prevention, diagnosis, mitigation, treatment, or cure of amyotrophic lateral sclerosis.
in subsection (d)(1), by striking request described in subsection (a) and inserting grant; and
in subsection (e)—
in paragraph (2), by inserting , and that begins enrollment within a timeframe as determined by the Secretary through the terms and conditions of the grant before the period at the end; and
by adding at the end the following:
The term phase 3 clinical trial includes a phase 2/3 combined trial and a planned phase 3 clinical trial that is not yet enrolling participants.
Section 4 of the Accelerating Access to Critical Therapies for ALS Act (21 U.S.C. 360aa note) is amended—
in the section heading, by striking ALS and other and inserting FDA;
in subsection (a), in the matter preceding paragraph (1)—
by inserting and not later than 1 year after the date of enactment of the Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026 and every 5 years thereafter, after this Act,; and
by inserting develop, or update, as applicable, and before publish on;
in subsection (b)—
in the matter preceding paragraph (1), by striking initial;
in paragraph (2)—
in subparagraph (A), by inserting of relevant investigational new drug applications after sponsors;
in subparagraph (C) by inserting for the prevention, diagnosis, mitigation, treatment, or cure of rare neurodegenerative diseases before the semicolon; and
in subparagraph (D), by striking ; and and inserting a semicolon;
in paragraph (3), by striking the period at the end and inserting ; and; and
by adding at the end the following:
for each action plan published after the date of enactment of the Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026, include a description of—
previous actions taken by the Food and Drug Administration to implement the previous action plan published under subsection (a);
any other planned actions to implement such action plan; and
any barriers to implementing such action plan and related recommendations, which may include an estimate of resources necessary to address such barriers.
Section 6 of the Accelerating Access to Critical Therapies for ALS Act (Public Law 117–79) is amended—
in the heading, by striking GAO Report and inserting Reports;
by striking Not later than and inserting the following:
Not later than
in the matter preceding paragraph (1) of subsection (a), as so designated, by striking this Act and inserting the Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026; and
by adding at the end the following:
Not later than 4 years after the date of enactment of the Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026, the Secretary of Health and Human Services shall, in a manner that does not duplicate the information described in the action plan published pursuant to section 4, submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report assessing the effectiveness of the activities carried out under sections 2, 3, and 5 and making recommendations to improve such activities.
Section 3 of the Accelerating Access to Critical Therapies for ALS Act (42 U.S.C. 280g–7b) is amended—
in subsection (a), in the matter preceding paragraph (1), by striking amytrophic and inserting amyotrophic; and
in subsection (b)(3)(A)(iii), by striking rational.