MADE in America Act

II 117TH CONGRESS 1ST SESSION S. 2082 To mitigate drug shortages and provide incentives for maintaining, expanding, and relocating the manufacturing of active pharmaceutical ingredients, excipients, medical diagnostic devices, pharmaceuticals, and personal pro- tective equipment in the United States, and for other purposes. IN THE SENATE OF THE UNITED STATES JUNE 16, 2021 Mr. SCOTT of South Carolina (for himself and Ms. ROSEN) introduced the following bill; which was read twice and referred to the Committee on Finance A BILL To mitigate drug shortages and provide incentives for main- taining, expanding, and relocating the manufacturing of active pharmaceutical ingredients, excipients, medical di- agnostic devices, pharmaceuticals, and personal protec- tive equipment in the United States, and for other pur- poses. 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 ‘‘Manufacturing API, 4 Drugs, and Excipients in America Act’’ or the ‘‘MADE 5 in America Act’’. 6 VerDate Sep 11 2014 00:40 Jul 03, 2021 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S2082.IS S2082 SSpencer on DSK126QN23PROD with BILLS 2 •S 2082 IS SEC. 2. TABLE OF CONTENTS. 1 The table of contents of this Act is as follows: 2 Sec. 1. Short title. Sec. 2. Table of contents. TITLE I—HEALTH PROVISIONS Sec. 101. Report to Congress on barriers to domestic manufacturing of medical products. Sec. 102. Enhance intra-agency coordination and public health assessment with regard to compliance activities. Sec. 103. Reporting of mutual recognition agreements for inspections and re- view activities. Sec. 104. Enhancing transparency of drug facility inspection timelines. Sec. 105. Advanced manufacturing technologies program. TITLE II—TAX INCENTIVES TO INCREASE DOMESTIC PHARMACEUTICAL AND MEDICAL DEVICE PRODUCTION Sec. 201. Credit for pharmaceutical and medical device production activities in distressed zones. TITLE I—HEALTH PROVISIONS 3 SEC. 101. REPORT TO CONGRESS ON BARRIERS TO DOMES- 4 TIC MANUFACTURING OF MEDICAL PROD- 5 UCTS. 6 (a) REPORT.—Not later than 6 months after the date 7 of enactment of this Act, the Secretary of Health and 8 Human Services, the Secretary of the Treasury, the Sec- 9 retary of Commerce, and the United States Trade Rep- 10 resentative (collectively referred to in this section as the 11 ‘‘Secretaries’’) shall submit to the Committee on Health, 12 Education, Labor, and Pensions of the Senate and the 13 Committee on Energy and Commerce of the House of 14 Representatives a report on barriers to domestic manufac- 15 turing of active pharmaceutical ingredients, finished drug 16 VerDate Sep 11 2014 00:40 Jul 03, 2021 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S2082.IS S2082 SSpencer on DSK126QN23PROD with BILLS 3 •S 2082 IS products, and devices that are imported from outside of 1 the United States. 2 (b) CONTENTS.—Such report shall— 3 (1) identify factors that limit or otherwise dis- 4 courage the domestic manufacturing of active phar- 5 maceutical ingredients, drugs, and devices that are 6 currently imported from outside of the United 7 States, including any Federal, State, local, or Tribal 8 laws that hinder domestic manufacturing opportuni- 9 ties; and 10 (2) recommend specific strategies to overcome 11 the challenges identified under paragraph (1), in- 12 cluding strategies— 13 (A) to develop effective incentives for do- 14 mestic manufacturing; and 15 (B) to make changes to laws or regulations 16 that hinder domestic manufacturing opportuni- 17 ties. 18 (c) CONSULTATION.—In preparing the report under 19 subsection (a), the Secretaries shall consult with— 20 (1) the Food and Drug Administration, the 21 Centers for Medicare & Medicaid Services, the De- 22 partment of Defense, the Department of State, the 23 Department of Veterans Affairs, the Department of 24 VerDate Sep 11 2014 00:40 Jul 03, 2021 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S2082.IS S2082 SSpencer on DSK126QN23PROD with BILLS 4 •S 2082 IS Justice, and any other Federal agencies as appro- 1 priate; and 2 (2) relevant stakeholders, including drug, de- 3 vice, and active pharmaceutical ingredient manufac- 4 turers, and other entities, as appropriate. 5 (d) DEFINITION.—In this section, the term ‘‘active 6 pharmaceutical ingredient’’ has the meaning given to such 7 term in section 207.1 of title 21, Code of Federal Regula- 8 tions (or any successor regulations). 9 (e) PUBLICATION.—The Secretary shall make the re- 10 port under subsection (a) available on the public website 11 of the Department of Health and Human Services. 12 SEC. 102. ENHANCE INTRA-AGENCY COORDINATION AND 13 PUBLIC HEALTH ASSESSMENT WITH REGARD 14 TO COMPLIANCE ACTIVITIES. 15 (a) COORDINATION.—Section 506D of the Federal 16 Food, Drug, and Cosmetic Act (21 U.S.C. 356d) is 17 amended by adding at the end the following: 18 ‘‘(g) COORDINATION.—The Secretary shall ensure 19 timely and effective internal coordination and alignment 20 among the field investigators of the Food and Drug Ad- 21 ministration and the staff of the Center for Drug Evalua- 22 tion and Research’s Office of Compliance and Drug Short- 23 age Program regarding the reviews of reports shared pur- 24 VerDate Sep 11 2014 00:40 Jul 03, 2021 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S2082.IS S2082 SSpencer on DSK126QN23PROD with BILLS 5 •S 2082 IS suant to section 704(b)(2), and any feedback or corrective 1 or preventive actions in response to such reports.’’. 2 (b) REPORTING.—Section 506C–1(a)(2) of the Fed- 3 eral Food, Drug, and Cosmetic Act (21 U.S.C. 356c– 4 1(a)(2)) is amended to read as follows: 5 ‘‘(2)(A) describes the communication between 6 the field investigators of the Food and Drug Admin- 7 istration and the staff of the Center for Drug Eval- 8 uation and Research’s Office of Compliance and 9 Drug Shortage Program, including the Food and 10 Drug Administration’s procedures for enabling and 11 ensuring such communication; 12 ‘‘(B) provides the number of reports described 13 in section 704(b)(2) that were required to be sent to 14 the appropriate offices of the Food and Drug Ad- 15 ministration with expertise regarding drug shortage 16 and the number of such reports that were sent; and 17 ‘‘(C) describes the adoption and utilization of 18 the approach described in section 506D(g);’’. 19 (c) APPLICABILITY.— 20 (1) SUBSECTION (a).—The amendment made 21 by subsection (a) shall apply beginning on the date 22 of enactment of this Act. 23 (2) SUBSECTION (b).—The amendment made 24 by subsection (b) shall apply beginning on the date 25 VerDate Sep 11 2014 00:40 Jul 03, 2021 Jkt 019200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S2082.IS S2082 SSpencer on DSK126QN23PROD with BILLS 6 •S 2082 IS that is 1 year after the date of enactment of this 1 Act. 2 SEC. 103. REPORTING OF MUTUAL RECOGNITION AGREE- 3 MENTS FOR INSPECTIONS AND REVIEW AC- 4 TIVITIES. 5 (a) IN GENERAL.—Not later than the end of calendar 6 year 2020, and annually thereafter, the Secretary of 7 Health and Human Services (referred to in this section 8 as the ‘‘Secretary’’) shall publish a report on the public 9 website of the Food and Drug Administration on the utili- 10 zation of agreements entered into pursuant to section 809 11 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 12 384e) or otherwise entered into by the Secretary to recog- 13 nize inspections between drug regulatory authorities 14 across countries and international regions with analogous 15 review criteria to the Food and Drug Administration, such 16 as the Pharmaceutical Inspection Co-Operation Scheme, 17 the Mutual Recognition Agreement with the European 18 Union, and the Australia-Canada-Singapore-Switzerland 19 Consortium, in the previous fiscal year. 20 (b) CONTENT.—The report under subsection (a) shall 21 include each of the following: 22 (1) The total number of establishments that are 23 registered under section 510(i) of the Federal Food, 24 Drug, and Cosmetic Act (21 U.S.C. 360(i)), and of 25 VerDate Sep 11 2014 00:40 Jul 03, 2021 Jkt 019200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S2082.IS S2082 SSpencer on DSK126QN23PROD with BILLS 7 •S 2082 IS such establishments, the number in each region of 1 interest. 2 (2) The total number of inspections conducted 3 as described in subparagraphs (A) and (B) of para- 4 graph (5) at establishments described in paragraph 5 (1). 6 (3) Of the inspections described in paragraph 7 (2), the total number of inspections in each of region 8 of interest. 9 (4) Of the inspections in each region of interest 10 reported pursuant to paragraph (3), the number of 11 inspections in each FDA inspection category. 12 (5) Of the number of inspections reported 13 under each of paragraphs (3) and (4)— 14 (A) the number of inspections which have 15 been conducted pursuant to an agreement or 16 other recognition described in subsection (a); 17 and 18 (B) the number of inspections which have 19 been conducted by employees or contractors of 20 the Food and Drug Administration. 21 (c) DEFINITIONS.—In this subsection: 22 (1) FDA INSPECTION CATEGORY.—The term 23 ‘‘FDA inspection category’’ means the following in- 24 spection categories: 25 VerDate Sep 11 2014 00:40 Jul 03, 2021 Jkt 019200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\S2082.IS S2082 SSpencer on DSK126QN23PROD with BILLS 8 •S 2082 IS (A) Inspections to support approvals of 1 changes to the manufacturing process of drugs 2 approved under section 505 of the Federal 3 Food, Drug, and Cosmetic Act (21 U.S.C. 355) 4 or section 351 of the Public Health Service Act 5 (42 U.S.C. 262). 6 (B) Good manufacturing practice surveil- 7 lance inspections. 8 (C) For-cause inspections. 9 (2) REGION OF INTEREST.—The term ‘‘region 10 of interest’’ means China, India, the European 11 Union, and any other geographic region as the Sec- 12 retary determines appropriate. 13 SEC. 104. ENHANCING TRANSPARENCY OF DRUG FACILITY 14 INSPECTION TIMELINES. 15 Section 902 of the FDA Reauthorization Act of 2017 16 (21 U.S.C. 355 note) is amended to read as follows: 17 ‘‘SEC. 902. ANNUAL REPORT ON INSPECTIONS. 18 ‘‘Not later than March 1 of each year, the Secretary 19 of Health and Human Services shall post on the public 20 website of the Food and Drug Administration information 21 related to inspections of facilities, including inspections 22 that are necessary for approval of a drug under subsection 23 (c) or (j) of section 505 of the Federal Food, Drug, and 24 Cosmetic Act (21 U.S.C. 355), approval of a device under 25 VerDate Sep 11 2014 00:40 Jul 03, 2021 Jkt 019200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\S2082.IS S2082 SSpencer on DSK126QN23PROD with BILLS 9 •S 2082 IS section 515 of such Act (21 U.S.C. 360e), or clearance 1 of a device under section 510(k) of such Act (21 U.S.C. 2 360(k)) that were conducted during the previous calendar 3 year. Such information shall include the following: 4 ‘‘(1) The median time following a request from 5 staff of the Food and Drug Administration review- 6 ing an application or report to the beginning of the 7 inspection, including— 8 ‘‘(A) the median time for drugs described 9 in section 505(j)(11)(A)(i) of the Federal Food, 10 Drug, and Cosmetic Act (21 U.S.C. 11 355(j)(11)(A)(i)); 12 ‘‘(B) the median time for drugs described 13 in section 506C(a) of such Act (21 U.S.C. 14 356c(a)) only; and 15 ‘‘(C) the median time for drugs on the 16 drug shortage list in effect under section 506E 17 of such Act (21 U.S.C. 356f). 18 ‘‘(2) The median time from the issuance of a 19 report pursuant to section 704(b) of such Act (21 20 U.S.C. 374(b)) to the sending of a warning letter, 21 issuance of an import alert, or holding of a regu- 22 latory meeting for inspections for which the Sec- 23 retary concluded that regulatory or enforcement ac- 24 tion was indicated, including the median time for 25 VerDate Sep 11 2014 00:40 Jul 03, 2021 Jkt 019200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\S2082.IS S2082 SSpencer on DSK126QN23PROD with BILLS 10 •S 2082 IS each category of drugs listed in subparagraphs (A) 1 through (C) of paragraph (1). 2 ‘‘(3) The median time from the sending of a 3 warning letter, issuance of an import alert, or hold- 4 ing of a regulatory meeting to resolution of the ac- 5 tions indicated to address the conditions or practices 6 observed during an inspection. 7 ‘‘(4) The number of facilities that were unable 8 to implement requested corrective or preventive ac- 9 tions following a report pursuant to such section 10 704(b), resulting in a withhold recommendation, in- 11 cluding the number of such times for each category 12 of drugs listed in subparagraphs (A) through (C) of 13 paragraph (1).’’. 14 SEC. 105. ADVANCED MANUFACTURING TECHNOLOGIES 15 PROGRAM. 16 Subchapter A of chapter V of the Federal Food, 17 Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amend- 18 ed by adding at the end the following: 19 ‘‘SEC. 524B. ADVANCED MANUFACTURING TECHNOLOGIES 20 PROGRAM. 21 ‘‘(a) IN GENERAL.—Not later than 1 year after the 22 date of enactment of the Manufacturing API, Drugs, and 23 Excipients in America Act, the Secretary shall continue 24 in effect the programs to facilitate the development and 25 VerDate Sep 11 2014 00:40 Jul 03, 2021 Jkt 019200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\S2082.IS S2082 SSpencer on DSK126QN23PROD with BILLS 11 •S 2082 IS review of an application under subsection (b) or (j) of sec- 1 tion 505 of this Act or subsection (a) or (k) of section 2 351 of the Public Health Service Act for a drug or biologi- 3 cal product that is manufactured using one of more ad- 4 vanced manufacturing technologies that have been des- 5 ignated in accordance with subsection (b). 6 ‘‘(b) DESIGNATION.—The Secretary shall designate a 7 method of manufacturing or development of a drug or bio- 8 logical product as an advanced manufacturing technology 9 under this section if it incorporates a novel technology or 10 uses an established technique or technology in a novel way 11 that— 12 ‘‘(1) enhances drug quality; or 13 ‘‘(2) improves the flexibility, robustness, or effi- 14 ciency of the manufacturing process to— 15 ‘‘(A) prevent or resolve a drug shortage; 16 ‘‘(B) reduce premarket development time; 17 or 18 ‘‘(C) increase the supply of drugs described 19 in paragraph (1) or (2) of section 506C(a) for 20 national emergencies. 21 ‘‘(c) CONSULTATION.—If the Secretary designates a 22 method of manufacturing as an advanced manufacturing 23 technology under this section, the Secretary shall take ac- 24 tions to expedite the development and implementation of 25 VerDate Sep 11 2014 00: [Text truncated for display. 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