MADE in America Act of 2020

I 116TH CONGRESS 2D SESSION H. R. 6930 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 MAY 19, 2020 Mr. CARTER of Georgia (for himself, Mr. GRIFFITH, Mr. MCKINLEY, Mr. CRAWFORD, and Mr. SOTO) introduced the following bill; which was re- ferred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently de- termined by the Speaker, in each case for consideration of such provisions 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 07:43 Jun 14, 2020 Jkt 099200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H6930.IH H6930 pbinns on DSKJLVW7X2PROD with BILLS 2 •HR 6930 IH SECTION 1. SHORT TITLE. 1 This Act may be cited as the ‘‘Manufacturing API, 2 Drugs, and Excipients in America Act of 2020’’ or the 3 ‘‘MADE in America Act of 2020’’. 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 and supplies. Sec. 102. Enhance intraagency coordination and public health assessment with regard to compliance activities. Sec. 103. Encouraging international harmonization. Sec. 104. Mutual recognition agreements for inspections and review activities. Sec. 105. Enhancing transparency of drug facility inspection timelines. Sec. 106. 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 AND SUPPLIES. 10 (a) REPORT.—Not later than January 1, 2021, the 11 Secretary of Health and Human Services (referred to in 12 this section as the ‘‘Secretary’’) shall submit to the Com- 13 mittee on Energy and Commerce of the House of Rep- 14 resentatives and the Committee on Health, Education, 15 Labor, and Pensions of the Senate a report on barriers 16 to domestic manufacturing of active pharmaceutical ingre- 17 VerDate Sep 11 2014 07:43 Jun 14, 2020 Jkt 099200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H6930.IH H6930 pbinns on DSKJLVW7X2PROD with BILLS 3 •HR 6930 IH dients, drugs, and devices that are sourced or manufac- 1 tured outside of 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 sourced or manufactured outside of the 7 United States, including any Federal, State, local, or 8 Tribal laws and regulations that hinder domestic 9 manufacturing opportunities; 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 carrying out the report 19 under subsection (a), the Secretary 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 Commerce, 23 the Department of State, the Department of Vet- 24 VerDate Sep 11 2014 07:43 Jun 14, 2020 Jkt 099200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H6930.IH H6930 pbinns on DSKJLVW7X2PROD with BILLS 4 •HR 6930 IH erans Affairs, the Department of Justice, and any 1 other Federal agencies as appropriate; 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 (and 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 INTRAAGENCY COORDINATION AND 13 PUBLIC HEALTH ASSESSMENT WITH REGARD 14 TO COMPLIANCE ACTIVITIES. 15 (a) BENEFIT/RISK FRAMEWORK.— 16 (1) IN GENERAL.—Paragraph (2) of section 17 704(b) of the Federal Food, Drug, and Cosmetic Act 18 (21 U.S.C. 374(b)) is amended by adding at the end 19 the following: ‘‘The Secretary shall ensure timely 20 and effective coordination among such offices re- 21 garding the reviews of such report and the align- 22 ment of any feedback regarding such report, and 23 any corrective or preventive actions in response to 24 such report, after consideration of the benefits and 25 VerDate Sep 11 2014 07:43 Jun 14, 2020 Jkt 099200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H6930.IH H6930 pbinns on DSKJLVW7X2PROD with BILLS 5 •HR 6930 IH risks to the public health, patient safety, the drug 1 supply and drug supply chain, and timely patient ac- 2 cess to drugs.’’. 3 (2) ANNUAL REPORTING.—Subsection (b) of 4 section 704 of the Federal Food, Drug, and Cos- 5 metic Act (21 U.S.C. 374) is amended by adding at 6 the end the following new paragraph: 7 ‘‘(3) On an annual basis, the Secretary shall prepare 8 a report on the utilization of the framework described in 9 paragraph (2) and post such report on the public website 10 of the Food and Drug Administration.’’. 11 (3) APPLICABILITY.—The amendments made 12 by paragraphs (1) and (2) shall take effect on the 13 effective date described in section 3112 of the 14 CARES Act (Public Law 116–136), after executing 15 the amendments made by such section 3112, and 16 shall apply beginning on the date that is 1 year after 17 the date of enactment of this Act. 18 (b) PUBLIC MEETING.—The Secretary of Health and 19 Human Services shall publish in the Federal Register a 20 notice of a public meeting to be held no later than six 21 months after the date of enactment of this Act to discuss 22 and obtain input and recommendations from public stake- 23 holders, including patient advocates, consumers, regulated 24 industry, and health care providers, regarding the con- 25 VerDate Sep 11 2014 07:43 Jun 14, 2020 Jkt 099200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H6930.IH H6930 pbinns on DSKJLVW7X2PROD with BILLS 6 •HR 6930 IH tents of a benefit/risk framework described in section 1 704(b)(2) of the Federal Food, Drug, and Cosmetic Act, 2 as amended by subsection (a), that supports a safe, stable, 3 redundant drug supply chain. 4 (c) GUIDANCE.—The Secretary of Health and 5 Human Services shall— 6 (1) not later than one year after the date of en- 7 actment of this Act, issue draft guidance regarding 8 the goals and implementation of a benefit/risk 9 framework described in subsection (b); and 10 (2) not later than two years after such date of 11 enactment, issue final guidance with respect to the 12 implementation of such a framework. 13 SEC. 103. ENCOURAGING INTERNATIONAL HARMONI- 14 ZATION. 15 (a) GAO STUDY.—Not later than one year after the 16 date of enactment of this Act, the Comptroller General 17 of the United States shall issue a report evaluating— 18 (1) the consistency with which the International 19 Conference on Harmonisation (in this section re- 20 ferred to as ‘‘ICH’’) guidelines on good manufac- 21 turing practices, including ICH Guidelines Q8–11, 22 are being implemented by drug regulatory authori- 23 ties across countries and international regions; 24 VerDate Sep 11 2014 07:43 Jun 14, 2020 Jkt 099200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H6930.IH H6930 pbinns on DSKJLVW7X2PROD with BILLS 7 •HR 6930 IH (2) whether domestic active pharmaceutical in- 1 gredient manufacturers (including any such contract 2 manufacturers) are provided sufficient opportunity 3 to participate with regulatory authorities in the de- 4 velopment of guidelines prior to implementation; 5 (3) whether divergence from ICH guidelines or 6 differing regulatory standards or requirements by 7 drug regulatory authorities across countries and 8 international regions creates— 9 (A) inefficiencies in drug manufacturing; 10 (B) incompatible requirements that can 11 contribute to or exacerbate drug shortages; and 12 (C) the most common areas of divergence 13 between ICH guidelines and regulatory stand- 14 ards and requirements by drug regulatory au- 15 thorities across countries and international re- 16 gions that, if rectified, may reduce the ineffi- 17 ciencies and incompatibilities identified pursu- 18 ant to subparagraphs (A) and (B). 19 (b) INTERNATIONAL TRAINING PROGRAM.—Not later 20 than two years after the date of enactment of this Act, 21 informed by the needs identified in the report issued pur- 22 suant to subsection (a), the Secretary of Health and 23 Human Services, in conjunction with drug regulatory au- 24 thorities across countries and international regions and 25 VerDate Sep 11 2014 07:43 Jun 14, 2020 Jkt 099200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H6930.IH H6930 pbinns on DSKJLVW7X2PROD with BILLS 8 •HR 6930 IH the ICH, shall develop and implement a training program 1 for drug regulatory authorities across countries and inter- 2 national regions to promote consistent application of and 3 reduce divergence from ICH guidelines on good manufac- 4 turing practices. 5 SEC. 104. MUTUAL RECOGNITION AGREEMENTS FOR IN- 6 SPECTIONS AND REVIEW ACTIVITIES. 7 (a) MUTUAL RECOGNITION OF INSPECTIONS.—Pur- 8 suant to section 809 of the Federal Food, Drug and Cos- 9 metics Act (21 U.S.C. 384e), the Secretary of Health and 10 Human Services (in this section referred to as the ‘‘Sec- 11 retary’’) shall establish or expand initiatives for mutual 12 sharing of review and inspection criteria between drug reg- 13 ulatory authorities across countries and international re- 14 gions, such as through the Pharmaceutical Cooperation 15 Inspection Scheme, the Mutual Recognition Agreement 16 with the European Union, and the Australia-Canada- 17 Singapore-Switzerland Consortium, to— 18 (1) reduce the potential for duplicative regu- 19 latory evaluation of medical products regulated by 20 the Food and Drug Administration; and 21 (2) more constructively allocate appropriations 22 to the Food and Drug Administration, including 23 those attributable to user fees, to harmonized regu- 24 latory processes. 25 VerDate Sep 11 2014 07:43 Jun 14, 2020 Jkt 099200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H6930.IH H6930 pbinns on DSKJLVW7X2PROD with BILLS 9 •HR 6930 IH (b) ADDITIONAL COUNTRIES, REGIONS, AND EVAL- 1 UATION.—In carrying out subsection (a), the Secretary 2 may expand the initiatives to include— 3 (1) additional countries and geographic regions 4 with established and competent regulatory frame- 5 works; and 6 (2) additional types of regulatory evaluation, in- 7 cluding with respect to— 8 (A) good manufacturing practice inspec- 9 tions; and 10 (B) approval of changes to the manufac- 11 turing of drugs for which an approval or licen- 12 sure is in effect under section 505 of the Fed- 13 eral Food, Drug, and Cosmetic Act (21 U.S.C. 14 355) or section 351 of the Public Health Serv- 15 ice Act (42 U.S.C. 262). 16 (c) IMPLEMENTATION FRAMEWORK.— 17 (1) PUBLICATION.—Not later than one year 18 after the date of enactment of this Act, the Sec- 19 retary shall publish an implementation framework 20 for the agreements to share review and inspection 21 criteria under subsection (a) on the public website of 22 the Food and Drug Administration. 23 (2) CONTENTS.—The implementation frame- 24 work under this subsection shall— 25 VerDate Sep 11 2014 07:43 Jun 14, 2020 Jkt 099200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H6930.IH H6930 pbinns on DSKJLVW7X2PROD with BILLS 10 •HR 6930 IH (A) include the timeline for establishing or 1 expanding initiatives described in subsection 2 (a); 3 (B) describe additional types of regulatory 4 processes that will become subject to such ini- 5 tiatives; 6 (C) specify the countries and geographic 7 regions where such initiatives will be established 8 or expanded; and 9 (D) identify additional opportunities and 10 challenges for expanding mutual recognition 11 agreements in drug and biologic regulation. 12 (d) ANNUAL REPORTING.— 13 (1) IN GENERAL.—Not later than the end of 14 calendar year 2020 and annually thereafter, the Sec- 15 retary shall publish a report on the public website of 16 the Food and Drug Administration on the utilization 17 of agreements described in subsection (c)(1) in the 18 previous fiscal year. 19 (2) CONTENTS.—The report under paragraph 20 (1) shall include each of the following: 21 (A) The total number of establishments 22 that are registered under section 510(i) of the 23 Federal Food, Drug, and Cosmetic Act (21 24 U.S.C. 360) and located outside of the United 25 VerDate Sep 11 2014 07:43 Jun 14, 2020 Jkt 099200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\H6930.IH H6930 pbinns on DSKJLVW7X2PROD with BILLS 11 •HR 6930 IH States, and of these establishments, the number 1 in each region of interest. 2 (B) The total number of inspections con- 3 ducted at establishments described in subpara- 4 graph (A). 5 (C) Of the inspections described in sub- 6 paragraph (B), the total number of inspections 7 in each of region of interest. 8 (D) Of the inspections in each region of in- 9 terest reported pursuant to subparagraph (C), 10 the number of inspections in each FDA inspec- 11 tion category. 12 (E) Of the number of inspections reported 13 under each of subparagraphs (B), (C), and 14 (D)— 15 (i) the number of inspections which 16 have been conducted pursuant to an agree- 17 ment described in subsection (c)(1); and 18 (ii) the number of inspections which 19 have been conducted by employees or other 20 agents of the Food and Drug Administra- 21 tion. 22 (3) DEFINITIONS.—In this subsection: 23 (A) The term ‘‘region of interest’’ refers to 24 China, India, the European Uni [Text truncated for display. 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