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

by Frank Pallone

SEC. 511. FOOD AND DRUG ADMINISTRATION.

(a) FDA Innovation Account.—

(1) IN GENERAL.—Section 1002(b) of the 21st Century Cures Act (Public Law 114–255) is amended—

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

(B) by adding at the end the following new paragraph:

“(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, $417,500,000.

“(ii) For each of fiscal years 2023 and 2024, $157,500,000.

“(iii) For each of fiscal years 2025 through 2027, $152,500,000.

“(iv) For each of fiscal years 2028 through 2031, $202,500,000.

“(B) SUPPLEMENTAL FUNDING FOR CERTAIN ACTIVITIES.—Of the total amounts made available under subparagraph (A) for each of fiscal years 2028 through 2031, a total amount not to exceed $50,000,000 for each such fiscal year, shall be made available for the activities under subtitles A through F (including the amendments made by such subtitles) of title III of this Act and section 1014 (relating to Intercenter Institutes) of the Federal Food, Drug, and Cosmetic Act.

“(C) ADDITIONAL FDA ACTIVITIES.—In addition to funding activities 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 activities:

“(i) For modernization of the technical infrastructure of the Food and Drug Administration, including enhancements such as interoperability across the agency, and additional capabilities to develop an advanced information technology infrastructure to support the agency’s regulatory mission:

“(I) For fiscal year 2022, $180,000,000.

“(II) For each of fiscal years 2023 through 2031, $60,000,000.

“(ii) For support for continuous manufacturing of drugs and biological products, including complex biological products such as regenerative medicine therapies, through grants to institutions of higher education and nonprofit organizations and other appropriate mechanisms, for each of fiscal years 2022 through 2031, $20,000,000.

“(iii) For support for the Commissioner of Food and Drugs to engage experts, such as through the formation and operation of public-private partnerships or other appropriate collaborative efforts, to advance the development and delivery of individualized human gene therapy products:

“(I) For fiscal year 2022, $50,000,000.

“(II) For each of fiscal years 2023 through 2031, $10,000,000.

“(iv) For support for inspections, enforcement, and quality surveillance activities across the Food and Drug Administration, including foreign and domestic inspections across products, for each of fiscal years 2022 through 2031, $20,000,000.

“(v) For support for activities of the Food and Drug Administration related to customs and border protection to provide improvements to technologies, inspection capacity, and sites of import (including international mail facilities) in which the Food and Drug Administration operates, for each of fiscal years 2022 through 2031, $10,000,000.

“(vi) To further advance the development of a coordinated postmarket surveillance system for all medical products, including drugs, biological products, and devices, linked to electronic health records in furtherance of the Food and Drug Administration’s postmarket surveillance capabilities:

“(I) For fiscal year 2022, $112,500,000.

“(II) For each of fiscal years 2023 through 2031, $12,500,000.

“(vii) For support for Food and Drug Administration activities to keep pace with the projected product development of regenerative therapies, including cellular and somatic cell gene therapy products:

“(I) For each of fiscal years 2022 through 2024, $10,000,000.

“(II) For each of fiscal years 2025 through 2031, $5,000,000.

“(viii) For carrying out section 714A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379d–3a; relating to hiring authority for scientific, technical, and professional personnel), for each of fiscal years 2022 through 2031, $2,500,000.

“(ix) For the Food and Drug Administration to support improvements to the technological infrastructure for reporting and analysis of adverse events associated with the use of drugs and biological products, for each of fiscal years 2022 through 2031, $12,500,000.”.

(2) CONFORMING AMENDMENTS.—Section 1002 of the 21st Century Cures Act (Public Law 114–255) is amended—

(A) in subsection (a), by inserting before the period at the end the following: “or pursuant to subparagraph (A) of subsection (b)(5) to carry out the activities described in subparagraphs (B) and (C) of such subsection”; and

(B) in subsection (d)—

(i) by inserting “or pursuant to subparagraph (A) of subsection (b)(5)” after “subsection (b)(3)”; and

(ii) by striking “subsection (b)(4)” and inserting “subsections (b)(4) and (b)(5)”.

(b) Annual Report.—Section 1002(c)(2)(A) of the 21st Century Cures Act (Public Law 114–255) is amended, in the matter preceding clause (i), by striking “2026” and inserting “2032”.

(c) Sunset.—Section 1002(e) of the 21st Century Cures Act (Public Law 114–255) is amended by striking “September 30, 2025” and inserting “September 30, 2030”.

SEC. 512. STUDY ON HIGH-RISK, HIGH-REWARD DRUGS.

(a) In General.—Not later than 180 days after the date of enactment of this Act, the Secretary of Health and Human Services shall conduct a study to identify—

(1) diseases or conditions that lack a treatment approved by the Food and Drug Administration and instances in which development of a treatment for such diseases or conditions could fill an unmet medical need for the treatment of a serious or life-threatening disease or condition or a rare disease or condition; and

(2) appropriate incentives that would lead to the development, approval, and marketing of such treatments.

(b) Report To Congress; Recommendations.—Not later than one year after the date of enactment of this Act, the Secretary shall submit to the Congress a report that includes—

(1) findings from the study under subsection (a); and

(2) recommendations regarding legislation necessary to create appropriate incentives identified pursuant to subsection (a)(2).