Investing in Safety and Innovation Act of 2019

I 116TH CONGRESS 1ST SESSION H. R. 4633 To amend the 21st Century Cures Act to reauthorize funding for FDA innovation projects, and for other purposes. IN THE HOUSE OF REPRESENTATIVES OCTOBER 11, 2019 Ms. ESHOO (for herself and Mr. PETERS) introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL To amend the 21st Century Cures Act to reauthorize funding for FDA innovation projects, 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 ‘‘Investing in Safety 4 and Innovation Act of 2019’’. 5 SEC. 2. REAUTHORIZATION OF FDA INNOVATION 6 PROJECTS. 7 (a) TRANSFER OF DIRECT SPENDING SAVINGS.— 8 Section 1002(b)(2)(A) of the 21st Century Cures Act 9 (Public Law 114–255) is amended— 10 VerDate Sep 11 2014 01:07 Oct 12, 2019 Jkt 099200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H4633.IH H4633 kjohnson on DSK79L0C42 with BILLS 2 •HR 4633 IH (1) in the matter preceding clause (i), by strik- 1 ing ‘‘2025’’ and inserting ‘‘2029’’; and 2 (2) by striking clauses (iv) through (ix) and in- 3 serting the following: 4 ‘‘(iv) For fiscal year 2020, 5 $746,000,000. 6 ‘‘(v) For fiscal year 2021, 7 $551,000,000. 8 ‘‘(vi) For each of fiscal years 2022 9 through 2024, $531,000,000. 10 ‘‘(vii) For fiscal year 2025, 11 $536,000,000. 12 ‘‘(viii) For each of fiscal years 2026 13 through 2029, $531,000,000.’’. 14 (b) FDA ACTIVITIES.—Paragraph (4) of section 15 1002(b) of the 21st Century Cures Act (Public Law 114– 16 255) is amended to read as follows: 17 ‘‘(4) FDA ACTIVITIES.—The activities author- 18 ized to be funded under this section shall consist of 19 the following, and of the total amounts authorized to 20 be appropriated under paragraph (3) there are au- 21 thorized to be appropriated to each category of ac- 22 tivities a total amount not to exceed the following: 23 ‘‘(A) In addition to the allocations speci- 24 fied in subparagraphs (B) through (K), for the 25 VerDate Sep 11 2014 01:07 Oct 12, 2019 Jkt 099200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H4633.IH H4633 kjohnson on DSK79L0C42 with BILLS 3 •HR 4633 IH activities under subtitles A through F (includ- 1 ing the amendments made by such subtitles) of 2 title III of this Act and section 1014 of the 3 Federal Food, Drug, and Cosmetic Act, as 4 added by section 3073 of this Act: 5 ‘‘(i) For fiscal year 2020, 6 $75,000,000. 7 ‘‘(ii) For fiscal year 2021, 8 $70,000,000. 9 ‘‘(iii) For each of fiscal years 2022 10 through 2024, $50,000,000. 11 ‘‘(iv) For fiscal year 2025, 12 $55,000,000. 13 ‘‘(v) For each of fiscal years 2026 14 through 2029, $50,000,000. 15 ‘‘(B) For modernization of the technical 16 infrastructure of the Food and Drug Adminis- 17 tration, including enhancements such as inter- 18 operability across the agency, and additional ca- 19 pabilities to develop an advanced information 20 technology infrastructure to support the agen- 21 cy’s regulatory mission: 22 ‘‘(i) For fiscal year 2020, 23 $300,000,000. 24 VerDate Sep 11 2014 01:07 Oct 12, 2019 Jkt 099200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H4633.IH H4633 kjohnson on DSK79L0C42 with BILLS 4 •HR 4633 IH ‘‘(ii) For each of fiscal years 2021 1 through 2029, $200,000,000. 2 ‘‘(C) For support for continuous manufac- 3 turing of drugs and biological products, includ- 4 ing complex biological products such as regen- 5 erative medicine therapies, through grants to 6 institutions of higher education and nonprofit 7 organizations and other appropriate mecha- 8 nisms, for each of fiscal years 2020 through 9 2029, $50,000,000. 10 ‘‘(D) For support for the Commissioner of 11 Food and Drugs to engage experts, such as 12 through the formation and operation of public- 13 private partnerships or other appropriate col- 14 laborative efforts, to advance the development 15 and delivery of individualized human gene ther- 16 apy products: 17 ‘‘(i) For fiscal year 2020, 18 $50,000,000. 19 ‘‘(ii) For each of fiscal years 2021 20 through 2029, $10,000,000. 21 ‘‘(E) For support for inspections and en- 22 forcement activities across the Food and Drug 23 Administration, including foreign and domestic 24 VerDate Sep 11 2014 01:07 Oct 12, 2019 Jkt 099200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H4633.IH H4633 kjohnson on DSK79L0C42 with BILLS 5 •HR 4633 IH facility inspections across products, for each of 1 fiscal years 2020 through 2029, $82,500,000. 2 ‘‘(F) For support for activities of the Food 3 and Drug Administration related to customs 4 and border protection to provide improvements 5 to technologies, inspection capacity, and inter- 6 national mail facilities in which the Food and 7 Drug Administration operates, for each of fiscal 8 years 2020 through 2029, $25,000,000. 9 ‘‘(G) To further advance the development 10 of a coordinated postmarket surveillance system 11 for all medical products, including drugs, bio- 12 logical products, and devices, linked to elec- 13 tronic health records in furtherance of the Food 14 and Drug Administration’s postmarket surveil- 15 lance capabilities: 16 ‘‘(i) For fiscal year 2020, 17 $100,000,000. 18 ‘‘(ii) For each of fiscal years 2021 19 through 2029, $50,000,000. 20 ‘‘(H) For support for Food and Drug Ad- 21 ministration activities to keep pace with the 22 projected product development of regenerative 23 therapies, including human somatic cellular and 24 VerDate Sep 11 2014 01:07 Oct 12, 2019 Jkt 099200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H4633.IH H4633 kjohnson on DSK79L0C42 with BILLS 6 •HR 4633 IH gene therapies, for each of fiscal years 2020 1 through 2029, $25,000,000. 2 ‘‘(I) For support for the development of 3 non-opioid pharmacological therapies as alter- 4 natives for opioids, for each of fiscal years 2020 5 through 2029, $3,500,000. 6 ‘‘(J) For carrying out section 714A of the 7 Federal Food, Drug, and Cosmetic Act (21 8 U.S.C. 379d–3a; relating to hiring authority for 9 scientific, technical, and professional personnel), 10 for each of fiscal years 2020 through 2029, 11 $20,000,000. 12 ‘‘(K) For the Food and Drug Administra- 13 tion to support improvements to the techno- 14 logical infrastructure for reporting and analysis 15 of adverse events associated with the use of 16 drugs and biological products, for each of fiscal 17 years 2020 through 2029, $15,000,000.’’. 18 (c) ANNUAL REPORTS.—Section 1002(c)(2)(A) of the 19 21st Century Cures Act (Public Law 114–255) is amend- 20 ed by striking ‘‘2026’’ and inserting ‘‘2029’’. 21 (d) SUNSET.—Section 1002(e) of the 21st Century 22 Cures Act (Public Law 114–255) is amended by striking 23 VerDate Sep 11 2014 01:07 Oct 12, 2019 Jkt 099200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H4633.IH H4633 kjohnson on DSK79L0C42 with BILLS 7 •HR 4633 IH ‘‘September 30, 2026’’ and inserting ‘‘September 30, 1 2029’’. 2 Æ VerDate Sep 11 2014 01:07 Oct 12, 2019 Jkt 099200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6301 E:\BILLS\H4633.IH H4633 kjohnson on DSK79L0C42 with BILLS