MADE in America Act

I 117TH CONGRESS 1ST SESSION H. R. 3927 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 HOUSE OF REPRESENTATIVES JUNE 16, 2021 Mr. CARTER of Georgia (for himself, Mr. RICE of South Carolina, Mr. SOTO, Mr. CARTWRIGHT, Mr. VAN DREW, Mr. WESTERMAN, Mr. CRAWFORD, Mr. MCKINLEY, and Mr. GRIFFITH) introduced the following bill; which was referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provi- sions as fall within the jurisdiction of the committee concerned 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 VerDate Sep 11 2014 01:29 Jul 16, 2021 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H3927.IH H3927 ctelli on DSK11ZRN23PROD with BILLS 2 •HR 3927 IH SECTION 1. SHORT TITLE. 1 This Act may be cited as the ‘‘Manufacturing API, 2 Drugs, and Excipients in America Act’’ or the ‘‘MADE 3 in America Act’’. 4 SEC. 2. TABLE OF CONTENTS. 5 The table of contents of this Act is as follows: 6 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 7 SEC. 101. REPORT TO CONGRESS ON BARRIERS TO DOMES- 8 TIC MANUFACTURING OF MEDICAL PROD- 9 UCTS. 10 (a) REPORT.—Not later than 6 months after the date 11 of enactment of this Act, the Secretary of Health and 12 Human Services, the Secretary of the Treasury, the Sec- 13 retary of Commerce, and the United States Trade Rep- 14 resentative (collectively referred to in this section as the 15 ‘‘Secretaries’’) shall submit to the Committee on Health, 16 Education, Labor, and Pensions of the Senate and the 17 VerDate Sep 11 2014 01:29 Jul 16, 2021 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H3927.IH H3927 ctelli on DSK11ZRN23PROD with BILLS 3 •HR 3927 IH Committee on Energy and Commerce of the House of 1 Representatives a report on barriers to domestic manufac- 2 turing of active pharmaceutical ingredients, finished drug 3 products, and devices that are imported from outside of 4 the United States. 5 (b) CONTENTS.—Such report shall— 6 (1) identify factors that limit or otherwise dis- 7 courage the domestic manufacturing of active phar- 8 maceutical ingredients, drugs, and devices that are 9 currently imported from outside of the United 10 States, including any Federal, State, local, or Tribal 11 laws that hinder domestic manufacturing opportuni- 12 ties; and 13 (2) recommend specific strategies to overcome 14 the challenges identified under paragraph (1), in- 15 cluding strategies— 16 (A) to develop effective incentives for do- 17 mestic manufacturing; and 18 (B) to make changes to laws or regulations 19 that hinder domestic manufacturing opportuni- 20 ties. 21 (c) CONSULTATION.—In preparing the report under 22 subsection (a), the Secretaries shall consult with— 23 (1) the Food and Drug Administration, the 24 Centers for Medicare & Medicaid Services, the De- 25 VerDate Sep 11 2014 01:29 Jul 16, 2021 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H3927.IH H3927 ctelli on DSK11ZRN23PROD with BILLS 4 •HR 3927 IH partment of Defense, the Department of State, the 1 Department of Veterans Affairs, the Department of 2 Justice, and any other Federal agencies as appro- 3 priate; and 4 (2) relevant stakeholders, including drug, de- 5 vice, and active pharmaceutical ingredient manufac- 6 turers, and other entities, as appropriate. 7 (d) DEFINITION.—In this section, the term ‘‘active 8 pharmaceutical ingredient’’ has the meaning given to such 9 term in section 207.1 of title 21, Code of Federal Regula- 10 tions (or any successor regulations). 11 (e) PUBLICATION.—The Secretary shall make the re- 12 port under subsection (a) available on the public website 13 of the Department of Health and Human Services. 14 SEC. 102. ENHANCE INTRA-AGENCY COORDINATION AND 15 PUBLIC HEALTH ASSESSMENT WITH REGARD 16 TO COMPLIANCE ACTIVITIES. 17 (a) COORDINATION.—Section 506D of the Federal 18 Food, Drug, and Cosmetic Act (21 U.S.C. 356d) is 19 amended by adding at the end the following: 20 ‘‘(g) COORDINATION.—The Secretary shall ensure 21 timely and effective internal coordination and alignment 22 among the field investigators of the Food and Drug Ad- 23 ministration and the staff of the Center for Drug Evalua- 24 tion and Research’s Office of Compliance and Drug Short- 25 VerDate Sep 11 2014 01:29 Jul 16, 2021 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H3927.IH H3927 ctelli on DSK11ZRN23PROD with BILLS 5 •HR 3927 IH age Program regarding the reviews of reports shared pur- 1 suant to section 704(b)(2), and any feedback or corrective 2 or preventive actions in response to such reports.’’. 3 (b) REPORTING.—Section 506C–1(a)(2) of the Fed- 4 eral Food, Drug, and Cosmetic Act (21 U.S.C. 356c– 5 1(a)(2)) is amended to read as follows: 6 ‘‘(2)(A) describes the communication between 7 the field investigators of the Food and Drug Admin- 8 istration and the staff of the Center for Drug Eval- 9 uation and Research’s Office of Compliance and 10 Drug Shortage Program, including the Food and 11 Drug Administration’s procedures for enabling and 12 ensuring such communication; 13 ‘‘(B) provides the number of reports described 14 in section 704(b)(2) that were required to be sent to 15 the appropriate offices of the Food and Drug Ad- 16 ministration with expertise regarding drug shortage 17 and the number of such reports that were sent; and 18 ‘‘(C) describes the adoption and utilization of 19 the approach described in section 506D(g);’’. 20 (c) APPLICABILITY.— 21 (1) SUBSECTION (a).—The amendment made 22 by subsection (a) shall apply beginning on the date 23 of enactment of this Act. 24 VerDate Sep 11 2014 01:29 Jul 16, 2021 Jkt 019200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H3927.IH H3927 ctelli on DSK11ZRN23PROD with BILLS 6 •HR 3927 IH (2) SUBSECTION (b).—The amendment made 1 by subsection (b) shall apply beginning on the date 2 that is 1 year after the date of enactment of this 3 Act. 4 SEC. 103. REPORTING OF MUTUAL RECOGNITION AGREE- 5 MENTS FOR INSPECTIONS AND REVIEW AC- 6 TIVITIES. 7 (a) IN GENERAL.—Not later than the end of calendar 8 year 2020, and annually thereafter, the Secretary of 9 Health and Human Services (referred to in this section 10 as the ‘‘Secretary’’) shall publish a report on the public 11 website of the Food and Drug Administration on the utili- 12 zation of agreements entered into pursuant to section 809 13 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 14 384e) or otherwise entered into by the Secretary to recog- 15 nize inspections between drug regulatory authorities 16 across countries and international regions with analogous 17 review criteria to the Food and Drug Administration, such 18 as the Pharmaceutical Inspection Co-Operation Scheme, 19 the Mutual Recognition Agreement with the European 20 Union, and the Australia-Canada-Singapore-Switzerland 21 Consortium, in the previous fiscal year. 22 (b) CONTENT.—The report under subsection (a) shall 23 include each of the following: 24 VerDate Sep 11 2014 01:29 Jul 16, 2021 Jkt 019200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H3927.IH H3927 ctelli on DSK11ZRN23PROD with BILLS 7 •HR 3927 IH (1) The total number of establishments that are 1 registered under section 510(i) of the Federal Food, 2 Drug, and Cosmetic Act (21 U.S.C. 360(i)), and of 3 such establishments, the number in each region of 4 interest. 5 (2) The total number of inspections conducted 6 as described in subparagraphs (A) and (B) of para- 7 graph (5) at establishments described in paragraph 8 (1). 9 (3) Of the inspections described in paragraph 10 (2), the total number of inspections in each of region 11 of interest. 12 (4) Of the inspections in each region of interest 13 reported pursuant to paragraph (3), the number of 14 inspections in each FDA inspection category. 15 (5) Of the number of inspections reported 16 under each of paragraphs (3) and (4)— 17 (A) the number of inspections which have 18 been conducted pursuant to an agreement or 19 other recognition described in subsection (a); 20 and 21 (B) the number of inspections which have 22 been conducted by employees or contractors of 23 the Food and Drug Administration. 24 (c) DEFINITIONS.—In this subsection: 25 VerDate Sep 11 2014 01:29 Jul 16, 2021 Jkt 019200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H3927.IH H3927 ctelli on DSK11ZRN23PROD with BILLS 8 •HR 3927 IH (1) FDA INSPECTION CATEGORY.—The term 1 ‘‘FDA inspection category’’ means the following in- 2 spection categories: 3 (A) Inspections to support approvals of 4 changes to the manufacturing process of drugs 5 approved under section 505 of the Federal 6 Food, Drug, and Cosmetic Act (21 U.S.C. 355) 7 or section 351 of the Public Health Service Act 8 (42 U.S.C. 262). 9 (B) Good manufacturing practice surveil- 10 lance inspections. 11 (C) For-cause inspections. 12 (2) REGION OF INTEREST.—The term ‘‘region 13 of interest’’ means China, India, the European 14 Union, and any other geographic region as the Sec- 15 retary determines appropriate. 16 SEC. 104. ENHANCING TRANSPARENCY OF DRUG FACILITY 17 INSPECTION TIMELINES. 18 Section 902 of the FDA Reauthorization Act of 2017 19 (21 U.S.C. 355 note) is amended to read as follows: 20 ‘‘SEC. 902. ANNUAL REPORT ON INSPECTIONS. 21 ‘‘Not later than March 1 of each year, the Secretary 22 of Health and Human Services shall post on the public 23 website of the Food and Drug Administration information 24 related to inspections of facilities, including inspections 25 VerDate Sep 11 2014 01:29 Jul 16, 2021 Jkt 019200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H3927.IH H3927 ctelli on DSK11ZRN23PROD with BILLS 9 •HR 3927 IH that are necessary for approval of a drug under subsection 1 (c) or (j) of section 505 of the Federal Food, Drug, and 2 Cosmetic Act (21 U.S.C. 355), approval of a device under 3 section 515 of such Act (21 U.S.C. 360e), or clearance 4 of a device under section 510(k) of such Act (21 U.S.C. 5 360(k)) that were conducted during the previous calendar 6 year. Such information shall include the following: 7 ‘‘(1) The median time following a request from 8 staff of the Food and Drug Administration review- 9 ing an application or report to the beginning of the 10 inspection, including— 11 ‘‘(A) the median time for drugs described 12 in section 505(j)(11)(A)(i) of the Federal Food, 13 Drug, and Cosmetic Act (21 U.S.C. 14 355(j)(11)(A)(i)); 15 ‘‘(B) the median time for drugs described 16 in section 506C(a) of such Act (21 U.S.C. 17 356c(a)) only; and 18 ‘‘(C) the median time for drugs on the 19 drug shortage list in effect under section 506E 20 of such Act (21 U.S.C. 356f). 21 ‘‘(2) The median time from the issuance of a 22 report pursuant to section 704(b) of such Act (21 23 U.S.C. 374(b)) to the sending of a warning letter, 24 issuance of an import alert, or holding of a regu- 25 VerDate Sep 11 2014 01:29 Jul 16, 2021 Jkt 019200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H3927.IH H3927 ctelli on DSK11ZRN23PROD with BILLS 10 •HR 3927 IH latory meeting for inspections for which the Sec- 1 retary concluded that regulatory or enforcement ac- 2 tion was indicated, including the median time for 3 each category of drugs listed in subparagraphs (A) 4 through (C) of paragraph (1). 5 ‘‘(3) The median time from the sending of a 6 warning letter, issuance of an import alert, or hold- 7 ing of a regulatory meeting to resolution of the ac- 8 tions indicated to address the conditions or practices 9 observed during an inspection. 10 ‘‘(4) The number of facilities that were unable 11 to implement requested corrective or preventive ac- 12 tions following a report pursuant to such section 13 704(b), resulting in a withhold recommendation, in- 14 cluding the number of such times for each category 15 of drugs listed in subparagraphs (A) through (C) of 16 paragraph (1).’’. 17 SEC. 105. ADVANCED MANUFACTURING TECHNOLOGIES 18 PROGRAM. 19 Subchapter A of chapter V of the Federal Food, 20 Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amend- 21 ed by adding at the end the following: 22 VerDate Sep 11 2014 01:29 Jul 16, 2021 Jkt 019200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\H3927.IH H3927 ctelli on DSK11ZRN23PROD with BILLS 11 •HR 3927 IH ‘‘SEC. 524B. ADVANCED MANUFACTURING TECHNOLOGIES 1 PROGRAM. 2 ‘‘(a) IN GENERAL.—Not later than 1 year after the 3 date of enactment of the Manufacturing API, Drugs, and 4 Excipients in America Act, the Secretary shall continue 5 in effect the programs to facilitate the development and 6 review of an application under subsection (b) or (j) of sec- 7 tion 505 of this Act or subsection (a) or (k) of section 8 351 of the Public Health Service Act for a drug or biologi- 9 cal product that is manufactured using one of more ad- 10 vanced manufacturing technologies that have been des- 11 ignated in accordance with subsection (b). 12 ‘‘(b) DESIGNATION.—The Secretary shall designate a 13 method of manufacturing or development of a drug or bio- 14 logical product as an advanced manufacturing technology 15 under this section if it incorporates a novel technology or 16 uses an established technique or technology in a novel way 17 that— 18 ‘‘(1) enhances drug quality; or 19 ‘‘(2) improves the flexibility, robustness, or effi- 20 ciency of the manufacturing process to— 21 ‘‘(A) prevent or resolve a drug shortage; 22 ‘‘(B) reduce premarket development time; 23 or 24 VerDate Sep 11 2014 01:29 Jul 16, 2021 Jkt 019200 PO 00000 [Text truncated for display. 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