PRIA, Government Policy, Made Personal

Summary

Not later than one year after December 23, 2021, the Secretary of Health and Human Services must set up and run a Public-Private Partnership for Neurodegenerative Diseases that includes the National Institutes of Health, the Food and Drug Administration, and one or more outside eligible groups. The Partnership must team up with public and private experts and patient groups, focus on research and regulatory work to speed the development and review of drugs, and help bring effective treatments for amyotrophic lateral sclerosis (ALS) and other rare neurodegenerative diseases. An eligible entity is a college or university (or group), or a 501(c)(3) nonprofit, that has experienced biomedical staff and links to patients; can build collaborations, develop tools and methods to study disease and find molecular targets, improve clinical trial efficiency and networks, and raise funding; and promises not to take project money from companies that make FDA-regulated products unless it ensures the results won’t be influenced. The Partnership may accept gifts, grants, and donations and may use those funds without more approval to support basic research and phase 3 clinical trials for investigational drugs that are the subject of expanded access requests under federal drug law.

Title 42, §280g–7b

The Public Health and Welfare, Source: USLM XML via OLRC

(a)Not later than one year after December 23, 2021, the Secretary of Health and Human Services (referred to in this section as the “Secretary”) shall establish and implement a Public-Private Partnership for Neurodegenerative Diseases between the National Institutes of Health, the Food and Drug Administration, and one or more eligible entities (to be known and referred to in this section as the “Partnership”) through cooperative agreements, contracts, or other appropriate mechanisms with such eligible entities, for the purpose of advancing the understanding of neurodegenerative diseases and fostering the development of treatments for amytrophic lateral sclerosis and other rare neurodegenerative diseases. The Partnership shall—

(1)establish partnerships and consortia with other public and private entities and individuals with expertise in amyotrophic lateral sclerosis and other rare neurodegenerative diseases for the purposes described in this subsection;

(2)focus on advancing regulatory science and scientific research that will support and accelerate the development and review of drugs for patients with amyotrophic lateral sclerosis and other rare neurodegenerative diseases; and

(3)foster the development of effective drugs that improve the lives of people that suffer from amyotrophic lateral sclerosis and other rare neurodegenerative diseases.

(b)In this section, the term “eligible entity” means an entity that—

(1)is—

(A)an institution of higher education (as such term is defined in section 1001 11 See References in Text note below. of title 20) or a consortium of such institutions; or

(B)an organization described in section 501(c)(3) of title 26 and exempt from tax under subsection (a) of such section;

(2)has experienced personnel with clinical and other technical expertise in the field of biomedical sciences and demonstrated connection to the patient population;

(3)demonstrates to the Secretary’s satisfaction that the entity is capable of identifying and establishing collaborations between public and private entities and individuals with expertise in neurodegenerative diseases, including patients, in order to facilitate—

(A)development and critical evaluation of tools, methods, and processes—

(i)to characterize neurodegenerative diseases and their natural history;

(ii)to identify molecular targets for neurodegenerative diseases; and

(iii)to increase efficiency, predictability, and productivity of clinical development of therapies, including advancement of rational therapeutic development and establishment of clinical trial networks; and

(B)securing funding for the Partnership from Federal and non-Federal governmental sources, foundations, and private individuals; and

(4)provides an assurance that the entity will not accept funding for a Partnership project from any organization that manufactures or distributes products regulated by the Food and Drug Administration unless the entity provides assurances in its agreement with the Secretary that the results of the project will not be influenced by any source of funding.

(c)(1)The Partnership may solicit and accept gifts, grants, and other donations, establish accounts, and invest and expend funds in support of basic research and research associated with phase 3 clinical trials conducted with respect to investigational drugs that are the subjects of expanded access requests under section 360bbb of title 21.

(2)In addition to any amounts appropriated for purposes of carrying out this section, the Partnership may use, without further appropriation, any funds derived from a gift, grant, or other donation accepted pursuant to paragraph (1).

Notes & Related Subsidiaries

Editorial Notes

References in Text

Section 1001 of title 20, referred to in subsec. (b)(1)(A), was in the original “section 1001 of the Higher Education Act of 1965” and was translated as if it had read “section 101 of the Higher Education Act of 1965” to reflect the probable intent of Congress. section 101 of the Higher Education Act of 1965 is classified to section 1001 of Title 20, Education, and defines “institution of higher education”. Codification Section was enacted as part of the Accelerating Access to Critical Therapies for ALS Act, and not as part of the Public Health Service Act which comprises this chapter.

§280g–7b Hhs Public-private Partnership for Rare Neurodegenerative Diseases

Summary

Title 42, §280g–7b

Notes & Related Subsidiaries

Editorial Notes

References in Text

Citations & Metadata