Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 8205 Introduced in House (IH)]

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119th CONGRESS
  2d Session
                                H. R. 8205

 To amend the Accelerating Access to Critical Therapies for ALS Act to
 reauthorize the provisions of such Act through fiscal year 2031, and
                          for other purposes.

_______________________________________________________________________

                    IN THE HOUSE OF REPRESENTATIVES

                             April 6, 2026

  Mr. Quigley (for himself and Mr. Calvert) introduced the following
    bill; which was referred to the Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL

 To amend the Accelerating Access to Critical Therapies for ALS Act to
 reauthorize the provisions of such Act through fiscal year 2031, and
                          for other purposes.

    Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Accelerating Access to Critical
Therapies for ALS Reauthorization Act of 2026''.

SEC. 2. REAUTHORIZATION OF ACCELERATING ACCESS TO CRITICAL THERAPIES
              FOR ALS ACT.

    (a) In General.--Section 7 of the Accelerating Access to Critical
Therapies for ALS Act (Public Law 117-79) is amended by striking
``2026'' and inserting ``2031''.
    (b) Grants for ALS Research.--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''.
    (c) Sense of Congress.--The Committee on Energy and Commerce of the
House of Representatives expresses support for directly appropriating
funds to carry out each section of the Accelerating Access to Critical
Therapies for ALS Act (Public Law 117-79).

SEC. 3. IMPROVEMENTS TO PROGRAM FOR GRANTS FOR RESEARCH ON THERAPIES
              FOR ALS.

    (a) Clinical Trial Status Review.--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:
            ``(4) Clinical trial status review.--
                    ``(A) In general.--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.
                    ``(B) Interim clinical trial data.--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.''.
    (b) Clarifying Participating Clinical Trial Definition.--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:
            ``(4) 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.''.

SEC. 4. REPORT ON ALS AND OTHER RARE NEURODEGENERATIVE DISEASE ACTION
              PLANS.

    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:
    ``(c) Report on ALS and Other Rare Neurodegenerative Disease Action
Plans.--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--
            ``(1) an updated action plan, including--
                    ``(A) 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);
                    ``(B) a description of the resources necessary to
                implement each section of the plan within such 5-year
                period; and
                    ``(C) 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
            ``(2) 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--
                    ``(A) the actions taken by the Food and Drug
                Administration under the 2022 Action Plan;
                    ``(B) 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;
                    ``(C) any programs and initiatives that established
                or carried out as part of the implementation of the
                2022 Action Plan; and
                    ``(D) the extent to which the 2022 Action Plan was
                implemented with respect to rare neurodegenerative
                diseases that are not amyotrophic lateral sclerosis.''.

SEC. 5. GAO REPORT.

    Not later than 4 years after the date of enactment of this Act, the
Comptroller General of the United States shall submit to the Committee
on Energy and Commerce of the House of Representatives and the
Committee on Health, Education, Labor, and Pensions of the Senate a
report containing the analyses and data described in section 6 of the
Accelerating Access to Critical Therapies for ALS Act (Public Law 117-
79) (as in effect on the date of enactment of this Act).
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