Accelerating Access to Critical Therapies for ALS Act
This bill establishes a grant program, as well as a new center within the Food and Drug Administration (FDA), to facilitate access to investigational therapies for neurodegenerative diseases such as amyotrophic lateral sclerosis (i.e., ALS, also known as Lou Gehrig's disease, a progressive and fatal disease).
Specifically, the Department of Health and Human Services (HHS) must award grants for the provision of investigational drugs for ALS and other rapidly progressing neurodegenerative diseases through an expanded access (i.e., compassionate use) program. HHS may award these grants to (1) a small business that is the sponsor of an investigational new drug application, or (2) a participating clinical trial site for such a sponsor.
Additionally, HHS must establish within the FDA a Center of Excellence for Neurodegenerative Diseases. The center shall have duties and authorities similar to those of the FDA's Oncology Center of Excellence, which helps expedite the development of medical products and assists providers in requesting access to investigational drugs.
[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 7071 Introduced in House (IH)]
<DOC>
116th CONGRESS
2d Session
H. R. 7071
To provide for the acceleration of access to clinical therapies for the
treatment of amyotrophic lateral sclerosis, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
June 1, 2020
Mr. Fortenberry (for himself and Mr. Quigley) introduced the following
bill; which was referred to the Committee on Energy and Commerce
_______________________________________________________________________
A BILL
To provide for the acceleration of access to clinical therapies for the
treatment of amyotrophic lateral sclerosis, 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 Act''.
SEC. 2. GRANTS FOR RAPID DEVELOPMENT OF THERAPIES FOR ALS AND OTHER
RAPIDLY PROGRESSING NEURODEGENERATIVE DISEASES.
(a) In General.--The Secretary of Health and Human Services shall
award grants to eligible entities for the provision of investigational
drugs through an expanded access program pursuant to section 561 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb) for individuals
for the prevention, diagnosis, mitigation, treatment, or cure of
amyotrophic lateral sclerosis or another rapidly progressing
neurodegenerative disease.
(b) Vested Authority.--For purposes of development of an
investigational drug pursuant to subsection (a), the Secretary may vest
authority in the participating clinical trial site or sites to make the
determination under subsection (b)(2), (c)(6), or (c)(7), as
applicable, of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360bbb).
(c) Timing.--Not later than 60 days after the date of submission of
an application for a grant under this section--
(1) the Secretary, acting through the Director of the
National Institutes of Health, shall determine whether to award
the grant; and
(2) the Secretary acting through the Commissioner of Food
and Drugs (or by vesting authority in the participating
clinical trial site, as applicable) shall make the
determinations required of the Secretary under subsection (b)
or (c), as applicable, of section 561 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 360bbb) for the provision of
the investigational drug to occur.
(d) Definitions.--In this section:
(1) The term ``Director'' means the Director of the
National Institutes of Health.
(2) The term ``eligible entity'' means an entity that is--
(A) a small business concern (as defined in section
3(a) of the Small Business Act (15 U.S.C. 632(a))) that
is the sponsor of a drug that is the subject of an
investigational new drug application under section
505(i) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355(i)); or
(B) a participating clinical trial site for such an
applicant.
(3) The term ``participating clinical trial'' means a phase
2 or phase 3 clinical trial conducted pursuant to an exemption
under section 505(i) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 355(i)) or section 351(a) of the Public Health
Service Act (42 U.S.C. 262(a)) to investigate a drug intended
to treat amyotrophic lateral sclerosis or another rapidly
progressing neurodegenerative disease.
(4) The term ``participating clinical trial site'' means a
health care facility at which patients participating in a
participating clinical trial receive treatment through such
trial.
(5) The term ``Secretary'' means the Secretary of Health
and Human Services.
(e) Funding.--
(1) Authorization of appropriations.--There are authorized
to be appropriated to carry out this section--
(A) $75,000,000 for each of fiscal years 2021 and
2022; and
(B) $150,000,000 for each of fiscal years 2023 and
2024.
(2) Gifts, grants, and other donations to foundation.--
(A) Acceptance.--Pursuant to section 499(c) of the
Public Health Service Act (42 U.S.C. 290b(c)), the
Foundation for the National Institutes of Health may
solicit and accept gifts, grants, and other donations,
establish accounts, and invest and expend funds in
support of carrying out this section.
(B) Use.--In addition to the amounts made available
pursuant to the authorizations of appropriations in
paragraph (1), the Director may use, without further
appropriation, any funds derived from a gift, grant, or
other donation accepted pursuant to subparagraph (A).
(f) Review and Expansion.--Not later than 18 months after the date
of the enactment of this Act--
(1) the Secretary of Health and Human Services shall
convene an independent review panel that includes
representatives of patients, researchers, drug sponsors, and
government agencies; and
(2) the independent review panel 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 on the findings and
conclusions of the panel with respect to the design and
implementation of the program under this section for 2023 and
2024.
SEC. 3. FDA CENTER OF EXCELLENCE FOR NEURODEGENERATIVE DISEASES.
Chapter X of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
391 et seq.) is amended by adding at the end the following:
``SEC. 1015. CENTER OF EXCELLENCE FOR NEURODEGENERATIVE DISEASES.
``(a) Establishment.--Not later than September 2021, the Secretary
shall establish within the Food and Drug Administration a center of
excellence, to be known as the Center of Excellence for
Neurodegenerative Diseases (in this section referred to as the `Center
of Excellence').
``(b) Duties and Authorities.--The Center of Excellence shall have
duties and authorities similar to those of the Center of Excellence for
Oncology established under section 1014, including the duties and
authorities of the Center of Excellence for Oncology with respect to
Project Facilitate.''.
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Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
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