Elijah E. Cummings Lower Drug Costs Now Act (H.R. 3; 117th Congress)/Title V/Subtitle A

by Frank Pallone

SEC. 501. NIH INNOVATION INITIATIVES.

(a) NIH Innovation Account.—

(1) IN GENERAL.—Section 1001(b) of the 21st Century Cures Act (Public Law 114–255) is amended by adding at the end the following:

“(5) SUPPLEMENTAL FUNDING AND ADDITIONAL ACTIVITIES.—

“(A) IN GENERAL.—In addition to the funds made available under paragraph (2), there are authorized to be appropriated, and are hereby appropriated, to the Account, out of any monies in the Treasury not otherwise appropriated, to be available until expended without further appropriation, the following:

“(i) For fiscal year 2022, $255,400,000.

“(ii) For fiscal year 2023, $160,400,000.

“(iii) For fiscal year 2024, $414,600,000.

“(iv) For fiscal year 2025, $547,000,000.

“(v) For fiscal year 2026, $948,000,000.

“(vi) For fiscal year 2027, $842,400,000.

“(vii) For fiscal year 2028, $1,089,600,000.

“(viii) For fiscal year 2029, $1,115,600,000.

“(ix) For fiscal year 2030, $1,170,600,000.

“(x) For fiscal year 2031, $956,400,000.

“(B) SUPPLEMENTAL FUNDING FOR CERTAIN PROJECTS.—Of the total amounts made available under subparagraph (A) for each of fiscal years 2022 through 2031, a total amount not to exceed the following shall be made available for the following categories of NIH Innovation Projects:

“(i) For projects described in paragraph (4)(A), an amount not to exceed a total of $2,070,600,000 as follows:

“(I) For each of fiscal years 2022 and 2024, $50,000,000.

“(II) For fiscal year 2025, $100,000,000.

“(III) For each of fiscal years 2026 and 2027, $300,000,000.

“(IV) For each of fiscal years 2028 through 2030, $317,000,000.

“(V) For fiscal year 2031, $319,600,000.

“(ii) For projects described in paragraph (4)(B), an amount not to exceed a total of $2,041,900,000 as follows:

“(I) For each of fiscal years 2022 and 2024, $50,000,000.

“(II) For fiscal year 2025, $128,000,000.

“(III) For fiscal year 2026, $209,000,000.

“(IV) For fiscal year 2027, $100,000,000.

“(V) For fiscal year 2028, $325,000,000.

“(VI) For fiscal year 2029, $350,000,000.

“(VII) For fiscal year 2030, $400,000,000.

“(VIII) For fiscal year 2031, $429,900,000.

“(iii) For projects described in paragraph (4)(C), an amount not to exceed a total of $1,558,400,000 as follows:

“(I) For each of fiscal years 2024 and 2025, $151,200,000.

“(II) For each of fiscal years 2026 through 2030, $251,200,000.

“(iv) For projects described in paragraph (4)(D), an amount not to exceed $15,400,000 for each of fiscal years 2022 through 2031.

“(C) ADDITIONAL NIH INNOVATION PROJECTS.—In addition to funding NIH Innovation Projects pursuant to subparagraph (B), of the total amounts made available under subparagraph (A), a total amount not to exceed the following shall be made available for the following categories of NIH Innovation Projects:

“(i) To support research related to combating antimicrobial resistance and antibiotic resistant bacteria, including research into new treatments, diagnostics, and vaccines, research, in consultation with the Centers for Disease Control and Prevention, into stewardship, and the development of strategies, in coordination with the Biomedical Advanced Research and Development Authority under section 319L of the Public Health Service Act, to support commercialization of new antibiotics, not to exceed a total of $1,144,500,000, as follows:

“(I) For each of fiscal years 2022 through 2025, $100,000,000.

“(II) For each of fiscal years 2026 and 2027, $120,000,000.

“(III) For each of fiscal years 2028 through 2030, $125,000,000.

“(IV) For fiscal year 2031, $129,500,000.

“(ii) To support research and research activities related to rare diseases or conditions, including studies or analyses that help to better understand the natural history of a rare disease or condition and translational studies related to rare diseases or conditions, not to exceed a total of $530,600,000, as follows:

“(I) For fiscal year 2022, $40,000,000.

“(II) For fiscal year 2023, $45,000,000.

“(III) For fiscal year 2024, $48,000,000.

“(IV) For each of fiscal years 2025 and 2026, $52,400,000.

“(V) For fiscal year 2027, $55,800,000.

“(VI) For fiscal year 2028, $56,000,000.

“(VII) For fiscal year 2029, $57,000,000.

“(VIII) For each of fiscal years 2030 and 2031, $62,000,000.”.

(2) CONFORMING AMENDMENTS.—Section 1001 of the 21st Century Cures Act (Public Law 114–255) is amended—

(A) in subsection (a), by striking “subsection (b)(4)” and inserting “subsections (b)(4) and (b)(5)”;

(B) in subsection (b)(1), by striking “paragraph (4)” and inserting “paragraphs (4) and (5)”;

(C) in subsection (c)(2)(A)(ii), by inserting “or pursuant to subsection (b)(5)” after “subsection (b)(3)”; and

(D) in subsection (d), by inserting “or pursuant to subsection (b)(5)” after “subsection (b)(3)”.

(b) Workplan.—Section 1001(c)(1) of the 21st Century Cures Act (Public Law 114–255) is amended by adding at the end the following:

“(D) UPDATES.—The Director of NIH shall, after seeking recommendations in accordance with the process described in subparagraph (C), update the work plan submitted under this subsection for each of fiscal years 2022 through 2031 to reflect the amendments made to this section by the Elijah E. Cummings Lower Drug Costs Now Act”..”.

(c) Annual Reports.—Section 1001(c)(2)(A) of the 21st Century Cures Act (Public Law 114–255) is amended by striking “2027” and inserting “2031”.

(d) Sunset.—Section 1001(e) of the 21st Century Cures Act (Public Law 114–255) is amended by striking “September 30, 2026” and inserting “September 30, 2031”.

SEC. 502. NIH CLINICAL TRIAL.

Part A of title IV of the Public Health Service Act (42 U.S.C. 281 et seq.) is amended by adding at the end the following:

“SEC. 404O. CLINICAL TRIAL ACCELERATION PILOT INITIATIVE.

“(a) Establishment Of Pilot Program.—The Secretary, acting through the Director of the National Institutes of Health, shall, not later than 2 years after the date of enactment of this Act, establish and implement a pilot program to award multi-year contracts to eligible entities to support phase II clinical trials and phase III clinical trials—

“(1) to promote innovation in treatments and technologies supporting the advanced research and development and production of high need cures; and

“(2) to provide support for the development of medical products and therapies.

“(b) Eligible Entities.—To be eligible to receive assistance under the pilot program established under subsection (a), an entity shall—

“(1) be seeking to market a medical product or therapy that is the subject of clinical trial or trials to be supported using such assistance;

“(2) be a public or private entity, which may include a private or public research institution, a contract research organization, an institution of higher education (as defined in section 101 of the Higher Education Act of 1965 (20 U.S.C. 1001)), a medical center, a biotechnology company, or an academic research institution; and

“(3) comply with requirements of the Federal Food, Drug, and Cosmetic Act and section 351 of this Act, as applicable, at all stages of development, manufacturing, review, approval, and safety surveillance of a medical product.

“(c) Duties.—The Secretary, acting through the Director of National Institutes of Health, shall—

“(1) in establishing the pilot program under subsection (a), consult with—

“(A) the Director of the National Center for Advancing Translational Sciences and the other national research institutes in considering their requests for new or expanded clinical trial support efforts; and

“(B) the Commissioner of Food and Drugs and any other head of a Federal agency as the Secretary determines to be appropriate to ensure coordination and efficiently advance clinical trial activities;

“(2) in implementing the pilot program under subsection (a), consider consulting with patients and patient advocates; and

“(3) in awarding contracts under the pilot program under subsection (a), consider—

“(A) the expected health impacts of the clinical trial or trials to be supported under the contract; and

“(B) the degree to which the medical product or therapy that is the subject of such clinical trial or trials is a high need cure.

“(d) Exclusion.—A contract may not be awarded under the pilot program under subsection (a) if the drug that is the subject of the clinical trial or trials to be supported under the contract is a drug designated under section 526 of the Federal Food, Drug, and Cosmetic Act as a drug for a rare disease or condition.

“(e) NIH Clinical Trial Accelerator Account.—

“(1) ESTABLISHMENT.—There is established in the Treasury an account, to be known as the ‘NIH Clinical Trial Accelerator Account’ (referred to in this section as the ‘Account’), for purposes of carrying out this section.

“(2) TRANSFER OF DIRECT SPENDING SAVINGS.—There shall be transferred to the Account from the general fund of the Treasury, $400,000,000 for each of fiscal years 2022 through 2026, to be available until expended without further appropriation.

“(3) WORK PLAN.—Not later than 180 days after the date of enactment of this Act, the Secretary 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 work plan that includes the proposed implementation of this section and the proposed allocation of funds in the Account.

“(f) Reports To Congress.—Not later than October 1 of each fiscal year, the Secretary 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—

“(1) the implementation of this section;

“(2) any available results on phase II clinical trials and phase III clinical trials supported under this section during such fiscal year; and

“(3) the extent to which Federal funds are obligated to support such clinical trials, including the specific amount of such support and awards pursuant to an allocation from the Account under subsection (e).

“(g) Definitions.—In this section:

“(1) PHASE II CLINICAL TRIAL.—The term ‘phase II clinical trial’ means a phase II clinical investigation, as described in section 312.21 of title 21, Code of Federal Regulations (or any successor regulations).

“(2) PHASE III CLINICAL TRIALS.—The term ‘phase III clinical trial’ means a phase III clinical investigation, as described in section 312.21 of title 21, Code of Federal Regulations (or any successor regulations).

“(3) HIGH NEED CURE.—The term ‘high need cure’ has the meaning given such term in section 480(a)(3).”.

SEC. 503. INNOVATION NETWORK.

Part A of title IV of the Public Health Service Act (42 U.S.C. 281 et seq.), as amended by section 502, is further amended by adding at the end the following:

“SEC. 404P. INNOVATION NETWORK.

“(a) Funds.—The Director of NIH shall award grants or contracts to eligible entities to develop, expand, and enhance the commercialization of biomedical products.

“(b) Eligible Entity.—In this section, the term ‘eligible entity’ means an entity receiving funding under—

“(1) the Small Business Innovation Research program of the National Institutes of Health; or

“(2) the Small Business Technology Transfer program of the National Institutes of Health.

“(c) Use Of Funds.—An eligible entity shall use the funds received through such grant or contract to support—

“(1) the Commercialization Readiness Pilot program of the National Institutes of Health;

“(2) the Innovation Corps program of the National Institutes of Health;

“(3) the Commercialization Accelerator program of the National Institutes of Health;

“(4) the Commercialization Assistance program of the National Institutes of Health; and

“(5) such other programs and activities as the Director of NIH determines to be appropriate, to support the commercialization stage of research, later stage research and development, technology transfer, and commercialization technical assistance.

“(d) Authorization Of Appropriations.—There are authorized to be appropriated to carry out this section $100,000,000 for each of fiscal years 2022 through 2026, to be available until expended.”.