Accelerating Access to Critical Therapies for ALS Act

I 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 Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Accelerating Access 4 to Critical Therapies for ALS Act’’. 5 SEC. 2. GRANTS FOR RAPID DEVELOPMENT OF THERAPIES 6 FOR ALS AND OTHER RAPIDLY PROGRESSING 7 NEURODEGENERATIVE DISEASES. 8 (a) IN GENERAL.—The Secretary of Health and 9 Human Services shall award grants to eligible entities for 10 VerDate Sep 11 2014 20:05 Jun 20, 2020 Jkt 099200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H7071.IH H7071 pamtmann on DSKBC07HB2PROD with BILLS 2 •HR 7071 IH the provision of investigational drugs through an expanded 1 access program pursuant to section 561 of the Federal 2 Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb) for 3 individuals for the prevention, diagnosis, mitigation, treat- 4 ment, or cure of amyotrophic lateral sclerosis or another 5 rapidly progressing neurodegenerative disease. 6 (b) VESTED AUTHORITY.—For purposes of develop- 7 ment of an investigational drug pursuant to subsection 8 (a), the Secretary may vest authority in the participating 9 clinical trial site or sites to make the determination under 10 subsection (b)(2), (c)(6), or (c)(7), as applicable, of the 11 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 12 360bbb). 13 (c) TIMING.—Not later than 60 days after the date 14 of submission of an application for a grant under this sec- 15 tion— 16 (1) the Secretary, acting through the Director 17 of the National Institutes of Health, shall determine 18 whether to award the grant; and 19 (2) the Secretary acting through the Commis- 20 sioner of Food and Drugs (or by vesting authority 21 in the participating clinical trial site, as applicable) 22 shall make the determinations required of the Sec- 23 retary under subsection (b) or (c), as applicable, of 24 section 561 of the Federal Food, Drug, and Cos- 25 VerDate Sep 11 2014 20:05 Jun 20, 2020 Jkt 099200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H7071.IH H7071 pamtmann on DSKBC07HB2PROD with BILLS 3 •HR 7071 IH metic Act (21 U.S.C. 360bbb) for the provision of 1 the investigational drug to occur. 2 (d) DEFINITIONS.—In this section: 3 (1) The term ‘‘Director’’ means the Director of 4 the National Institutes of Health. 5 (2) The term ‘‘eligible entity’’ means an entity 6 that is— 7 (A) a small business concern (as defined in 8 section 3(a) of the Small Business Act (15 9 U.S.C. 632(a))) that is the sponsor of a drug 10 that is the subject of an investigational new 11 drug application under section 505(i) of the 12 Federal Food, Drug, and Cosmetic Act (21 13 U.S.C. 355(i)); or 14 (B) a participating clinical trial site for 15 such an applicant. 16 (3) The term ‘‘participating clinical trial’’ 17 means a phase 2 or phase 3 clinical trial conducted 18 pursuant to an exemption under section 505(i) of 19 the Federal Food, Drug, and Cosmetic Act (21 20 U.S.C. 355(i)) or section 351(a) of the Public 21 Health Service Act (42 U.S.C. 262(a)) to investigate 22 a drug intended to treat amyotrophic lateral scle- 23 rosis or another rapidly progressing 24 neurodegenerative disease. 25 VerDate Sep 11 2014 20:05 Jun 20, 2020 Jkt 099200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H7071.IH H7071 pamtmann on DSKBC07HB2PROD with BILLS 4 •HR 7071 IH (4) The term ‘‘participating clinical trial site’’ 1 means a health care facility at which patients par- 2 ticipating in a participating clinical trial receive 3 treatment through such trial. 4 (5) The term ‘‘Secretary’’ means the Secretary 5 of Health and Human Services. 6 (e) FUNDING.— 7 (1) AUTHORIZATION OF APPROPRIATIONS.— 8 There are authorized to be appropriated to carry out 9 this section— 10 (A) $75,000,000 for each of fiscal years 11 2021 and 2022; and 12 (B) $150,000,000 for each of fiscal years 13 2023 and 2024. 14 (2) GIFTS, GRANTS, AND OTHER DONATIONS TO 15 FOUNDATION.— 16 (A) ACCEPTANCE.—Pursuant to section 17 499(c) of the Public Health Service Act (42 18 U.S.C. 290b(c)), the Foundation for the Na- 19 tional Institutes of Health may solicit and ac- 20 cept gifts, grants, and other donations, estab- 21 lish accounts, and invest and expend funds in 22 support of carrying out this section. 23 (B) USE.—In addition to the amounts 24 made available pursuant to the authorizations 25 VerDate Sep 11 2014 20:05 Jun 20, 2020 Jkt 099200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H7071.IH H7071 pamtmann on DSKBC07HB2PROD with BILLS 5 •HR 7071 IH of appropriations in paragraph (1), the Director 1 may use, without further appropriation, any 2 funds derived from a gift, grant, or other dona- 3 tion accepted pursuant to subparagraph (A). 4 (f) REVIEW AND EXPANSION.—Not later than 18 5 months after the date of the enactment of this Act— 6 (1) the Secretary of Health and Human Serv- 7 ices shall convene an independent review panel that 8 includes representatives of patients, researchers, 9 drug sponsors, and government agencies; and 10 (2) the independent review panel shall submit 11 to the Committee on Energy and Commerce of the 12 House of Representatives and the Committee on 13 Health, Education, Labor, and Pensions of the Sen- 14 ate a report on the findings and conclusions of the 15 panel with respect to the design and implementation 16 of the program under this section for 2023 and 17 2024. 18 SEC. 3. FDA CENTER OF EXCELLENCE FOR 19 NEURODEGENERATIVE DISEASES. 20 Chapter X of the Federal Food, Drug, and Cosmetic 21 Act (21 U.S.C. 391 et seq.) is amended by adding at the 22 end the following: 23 VerDate Sep 11 2014 20:05 Jun 20, 2020 Jkt 099200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H7071.IH H7071 pamtmann on DSKBC07HB2PROD with BILLS 6 •HR 7071 IH ‘‘SEC. 1015. CENTER OF EXCELLENCE FOR 1 NEURODEGENERATIVE DISEASES. 2 ‘‘(a) ESTABLISHMENT.—Not later than September 3 2021, the Secretary shall establish within the Food and 4 Drug Administration a center of excellence, to be known 5 as the Center of Excellence for Neurodegenerative Dis- 6 eases (in this section referred to as the ‘Center of Excel- 7 lence’). 8 ‘‘(b) DUTIES AND AUTHORITIES.—The Center of Ex- 9 cellence shall have duties and authorities similar to those 10 of the Center of Excellence for Oncology established under 11 section 1014, including the duties and authorities of the 12 Center of Excellence for Oncology with respect to Project 13 Facilitate.’’. 14 Æ VerDate Sep 11 2014 20:05 Jun 20, 2020 Jkt 099200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6301 E:\BILLS\H7071.IH H7071 pamtmann on DSKBC07HB2PROD with BILLS