HOME Act

II 116TH CONGRESS 2D SESSION S. 3780 To encourage domestic advanced manufacturing of critical drugs and devices in order to address economic, health, and security concerns, combat shortages of critical drugs and devices, and promote increased domestic diversification of, and independence from foreign reliance on, pharma- ceutical and medical device supply chains. IN THE SENATE OF THE UNITED STATES MAY 20, 2020 Mr. PETERS introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To encourage domestic advanced manufacturing of critical drugs and devices in order to address economic, health, and security concerns, combat shortages of critical drugs and devices, and promote increased domestic diversifica- tion of, and independence from foreign reliance on, phar- maceutical and medical device supply chains. 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 ‘‘Help Onshore Manu- 4 facturing Efficiencies for Drugs and Devices Act’’ or the 5 ‘‘HOME Act’’. 6 VerDate Sep 11 2014 23:15 Jun 11, 2020 Jkt 099200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S3780.IS S3780 kjohnson on DSK79L0C42PROD with BILLS 2 •S 3780 IS SEC. 2. INVESTMENTS IN DOMESTIC ADVANCED MANUFAC- 1 TURING AND PREPAREDNESS. 2 Part A of title III of the Public Health Service Act 3 (42 U.S.C. 241 et seq.) is amended by adding at the end 4 the following: 5 ‘‘SEC. 310B. INVESTMENTS IN DOMESTIC ADVANCED MANU- 6 FACTURING FOR CRITICAL DRUGS AND DE- 7 VICES. 8 ‘‘(a) ESTABLISHMENT.—There is established within 9 the Office of the Assistant Secretary for Preparedness and 10 Response of the Department of Health and Human Serv- 11 ices, the ‘Center for Domestic Advanced Manufacturing 12 of Critical Drugs and Devices’ (referred to in this section 13 as the ‘Center’). 14 ‘‘(b) PURPOSE.—The purpose of the Center for Do- 15 mestic Advanced Manufacturing of Critical Drugs and De- 16 vices shall be to implement a program to invest in the ad- 17 vanced manufacturing for critical drugs and devices, and 18 to increase domestic production of critical drugs and de- 19 vices, throughout the United States. 20 ‘‘(c) DIRECTOR.—The Center shall be headed by a 21 Director (referred to in this section as the ‘Director’) who 22 shall be appointed by the Secretary and to whom the Sec- 23 retary shall delegate such functions and authorities as 24 may be necessary to implement this section. 25 ‘‘(d) PROGRAM.— 26 VerDate Sep 11 2014 23:15 Jun 11, 2020 Jkt 099200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S3780.IS S3780 kjohnson on DSK79L0C42PROD with BILLS 3 •S 3780 IS ‘‘(1) IN GENERAL.—The Center for Domestic 1 Advanced Manufacturing of Critical Drugs and De- 2 vices shall— 3 ‘‘(A) not later than 18 months after the 4 date of enactment of this section— 5 ‘‘(i) establish an advisory board of ex- 6 perts from governmental entities, manufac- 7 turers, other private industry entities, non- 8 profit entities, and institutions of higher 9 education, and any other entity as deter- 10 mined by the Center; and 11 ‘‘(ii) compile a list of critical drugs 12 and devices that should be prioritized for 13 domestic advanced manufacturing and in- 14 creased domestic production under the pro- 15 gram described in paragraph (2), based on 16 reports to the Secretary under sections 17 506C and 506J of the Federal Food, 18 Drug, and Cosmetic Act, the drug shortage 19 list under section 506E of such Act, the 20 device shortage list under section 506J(g) 21 of such Act, and the annual risk assess- 22 ments described in section 5 of the HOME 23 Act, if available, and update such list quar- 24 terly; 25 VerDate Sep 11 2014 23:15 Jun 11, 2020 Jkt 099200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S3780.IS S3780 kjohnson on DSK79L0C42PROD with BILLS 4 •S 3780 IS ‘‘(B) establish and oversee the grant and 1 forgivable loan program described in paragraph 2 (2), including by establishing requirements for 3 participation in such program, including— 4 ‘‘(i) target goals to substantially in- 5 crease advanced manufacturing production 6 for critical drugs and devices within the 7 United States; and 8 ‘‘(ii) conditioning the receipt of fund- 9 ing under such program on an entity’s 10 agreement to commercially distribute the 11 drug or device in the United States; and 12 ‘‘(C) review the effects of the program de- 13 scribed in paragraph (2) on the percentage 14 change in domestic manufacturing of critical 15 drugs, devices, and active pharmaceutical ingre- 16 dients. 17 ‘‘(2) GRANT AND FORGIVABLE LOAN PRO- 18 GRAM.— 19 ‘‘(A) IN GENERAL.—The Center for Do- 20 mestic Advanced Manufacturing of Critical 21 Drugs and Devices shall establish a grant and 22 forgivable loan program in order to support in- 23 vestment in— 24 VerDate Sep 11 2014 23:15 Jun 11, 2020 Jkt 099200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S3780.IS S3780 kjohnson on DSK79L0C42PROD with BILLS 5 •S 3780 IS ‘‘(i) advanced manufacturing and fa- 1 cilities upgrades for the domestic produc- 2 tion of critical drugs, devices, and active 3 pharmaceutical ingredients; and 4 ‘‘(ii) increased domestic production 5 and diversification of critical drugs, de- 6 vices, and active pharmaceutical ingredi- 7 ents. 8 ‘‘(B) ELIGIBLE ENTITIES.— 9 ‘‘(i) IN GENERAL.—To be eligible to 10 receive a grant or forgivable loan under 11 this paragraph, an entity shall meet the re- 12 quirements established under paragraphs 13 (1)(A)(ii) and (1)(B) and such criteria as 14 the Center shall develop and, as applica- 15 ble— 16 ‘‘(I) with respect to a critical 17 drug, shall be the holder of an appli- 18 cation approved under section 505 of 19 the Federal Food, Drug, and Cos- 20 metic Act or section 351 of this Act, 21 or a contract manufacturer of the 22 drug for such holder of an approved 23 application; 24 VerDate Sep 11 2014 23:15 Jun 11, 2020 Jkt 099200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S3780.IS S3780 kjohnson on DSK79L0C42PROD with BILLS 6 •S 3780 IS ‘‘(II) with respect to an active 1 pharmaceutical ingredient, shall be 2 the manufacturer of an active phar- 3 maceutical ingredient of a drug ap- 4 proved under section 505 of the Fed- 5 eral Food, Drug, and Cosmetic Act or 6 section 351 of this Act; 7 ‘‘(III) with respect to a critical 8 device, shall have received approval 9 under section 515 of the Federal 10 Food, Drug, and Cosmetic Act, clear- 11 ance under section 510(k) of such Act 12 (or be exempt from the requirements 13 of such section 510(k)), or authoriza- 14 tion under section 513(f)(2) of such 15 Act, or shall be a contract manufac- 16 turer of the device for such an entity; 17 or 18 ‘‘(IV) with respect to a drug or 19 device, shall have submitted an appli- 20 cation under section 505 or 515 of the 21 Federal Food, Drug, and Cosmetic 22 Act or under section 351 of this Act, 23 a report under section 510(k), or a re- 24 quest under section 513(f)(2). 25 VerDate Sep 11 2014 23:15 Jun 11, 2020 Jkt 099200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S3780.IS S3780 kjohnson on DSK79L0C42PROD with BILLS 7 •S 3780 IS ‘‘(ii) PRIORITY.—In awarding grants 1 and forgivable loans under this paragraph 2 the Center for Domestic Advanced Manu- 3 facturing of Critical Drugs and Devices 4 shall give priority— 5 ‘‘(I) in the case of manufacturers 6 of drugs or active pharmaceutical in- 7 gredients, to entities— 8 ‘‘(aa) described in sub- 9 clauses (I) and (II) of clause (i); 10 and 11 ‘‘(bb) whose application for 12 an award under this paragraph 13 relates to a drug that was ap- 14 proved under section 505(j) of 15 the Federal Food, Drug, and 16 Cosmetic Act; and 17 ‘‘(II) in the case of manufactur- 18 ers of devices, to entities described in 19 clause (i)(III). 20 ‘‘(C) USE OF FUNDS.—Awards received 21 under this paragraph shall be used for the ad- 22 vanced manufacturing and increased production 23 of critical drugs and devices in the United 24 States. 25 VerDate Sep 11 2014 23:15 Jun 11, 2020 Jkt 099200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\S3780.IS S3780 kjohnson on DSK79L0C42PROD with BILLS 8 •S 3780 IS ‘‘(D) FORGIVABLE LOANS.—The Center 1 may award forgivable loans under this para- 2 graph under which a recipient shall receive a 3 loan and be eligible for forgiveness of indebted- 4 ness on such loan, under such conditions for re- 5 ceipt and forgiveness as the Center may estab- 6 lish. 7 ‘‘(E) GRANTS.—The Center may award 8 grants under this section, which shall be condi- 9 tioned upon the recipient matching Federal 10 funds so awarded. 11 ‘‘(F) FUNDING.—Out of amounts made 12 available to carry out this section, the Secretary 13 shall allocate $500,000,000 toward awards of 14 forgivable loans and grants under this para- 15 graph. 16 ‘‘(e) ANNUAL REPORTING.—The Secretary shall sub- 17 mit to the relevant committees of Congress annual reports 18 on the program under this section. At a minimum, each 19 such report shall— 20 ‘‘(1) identify the list of critical drugs and de- 21 vices under subsection (d)(1)(A)(ii) and account for 22 any alterations in the list; 23 VerDate Sep 11 2014 23:15 Jun 11, 2020 Jkt 099200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\S3780.IS S3780 kjohnson on DSK79L0C42PROD with BILLS 9 •S 3780 IS ‘‘(2) describe the participants in the program 1 under subsection (d)(2) and criteria for eligibility for 2 such participation; 3 ‘‘(3) address target goals for substantially in- 4 creased advanced manufacturing production for crit- 5 ical drugs and devices; and 6 ‘‘(4) review the percentage change in domestic 7 manufacturing of critical drugs, devices, and active 8 pharmaceutical ingredients since the most recent re- 9 port. 10 ‘‘(f) INTERAGENCY COOPERATION.— 11 ‘‘(1) IN GENERAL.—In carrying out activities 12 under this section, the Center is authorized, subject 13 to paragraph (2), to enter into interagency agree- 14 ments and other collaborative undertakings with 15 other Federal agencies. 16 ‘‘(2) LIMITATION.—An agreement or under- 17 taking under this subsection shall not authorize an- 18 other agency to exercise the authorities provided by 19 this section. 20 ‘‘(g) AUTHORIZATION OF APPROPRIATIONS.—To 21 carry out this section, there is authorized to be appro- 22 priated such funds as may be necessary, for each of fiscal 23 years 2021 through 2031. 24 ‘‘(h) DEFINITIONS.—In this section— 25 VerDate Sep 11 2014 23:15 Jun 11, 2020 Jkt 099200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\S3780.IS S3780 kjohnson on DSK79L0C42PROD with BILLS 10 •S 3780 IS ‘‘(1) the terms ‘drug’ and ‘device’ have the 1 meanings given such terms in section 201 of the 2 Federal Food, Drug, and Cosmetic Act; 3 ‘‘(2) the term ‘institution of higher education’ 4 has the meaning given such term in section 101(a) 5 of the Higher Education Act of 1965; and 6 ‘‘(3) the term ‘relevant committees of Congress’ 7 means the Committee on Homeland Security and 8 Governmental Affairs, the Committee on Health, 9 Education, Labor, and Pensions, and the Committee 10 on Armed Services of the Senate and the Committee 11 on Homeland Security, the Committee on Energy 12 and Commerce, and the Committee on Armed Serv- 13 ices of the House of Representatives.’’. 14 SEC. 3. EXPEDITED REVIEW OF CERTAIN SUPPLEMENTAL 15 APPLICATIONS. 16 Section 506 of the Federal Food, Drug, and Cosmetic 17 Act (21 U.S.C. 356) is amended by adding at the end the 18 following: 19 ‘‘(i) EXPEDITED REVIEW OF CERTAIN SUPPLE- 20 MENTAL APPLICATIONS.— 21 ‘‘(1) IN GENERAL.—The holder of an applica- 22 tion approved under section 505 of this Act or li- 23 cense under section 351 of the Public Health Service 24 Act who submits a supplemental application with re- 25 VerDate Sep 11 2014 23:15 Jun 11, 2020 Jkt 099200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\S3780.IS S3780 kjohnson on DSK79L0C42PROD with BILLS 11 •S 3780 IS spect to such application or license may request an 1 expedited review of such supplemental application 2 under this subsection. 3 ‘‘(2) APPLICATION.—To be eligible for expe- 4 dited review under this subsection, the holder of the 5 approved application or license with respect to a 6 drug included on the most recent list of critical 7 drugs and devices compiled under section 8 310B(d)(1)(A)(ii) of the Public Health Service Act, 9 shall demonstrate in the supplemental application 10 that— 11 ‘‘(A) approval of such supplemental appli- 12 cation would enable the incorporation of a man- 13 ufacturing change that is intended to enhance 14 drug quality, increase domestic manufacturing 15 of the drug, or incorporate the use of advanced 16 manufacturing; and 17 ‘‘(B) the applicant’s plan for producing the 18 drug domestically after approval of the supple- 19 mental application. 20 ‘‘(3) REVIEW BY SECRETARY.—If the Secretary 21 determines, after preliminary evaluation of a supple- 22 mental application, that the application dem- 23 onstrates that the manufacturing change would en- 24 hance the ability of the holder of the application to 25 VerDate Sep 11 2014 23:15 Jun 11, 2020 Jkt 099200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\S3780.IS S3780 kjohnson on DSK79L0C42PROD with BILLS 12 •S 3780 IS domestically manufacture a drug on the list of crit- 1 ical drugs and devices described in paragraph (2), 2 the Secretary shall evaluate for filing, and may com- 3 mence review of portions of, such supplemental ap- 4 plication before the sponsor submits a complete ap- 5 plication. The Secretary shall commence such review 6 only if the applicant provides a schedule for submis- 7 sion of information necessary to make the applica- 8 tion complete.’’. 9 SEC. 4. LONG-TERM, HIGH-VOLUME CONTRACTS TO PUR- 10 CHASE CRITICAL DRUGS AND DEVICES. 11 (a) CONTRACTING GOALS.— In order to further the 12 needs of the Department of Health and Human Services 13 and the Department of Defense, invest in preparedness 14 and the strategic national stockpile, and mitigate drug and 15 device shortages, each of the Secretary of Health and 16 Human Services and the Assistant Secretary of Defense 17 for Health Affairs may enter into contracts to purchase 18 a drug or device included on the list of critical drugs and 19 devices compiled under section 310B(d)(1)(A)(ii) of the 20 Public Health Service Act (as added by section 2), includ- 21 ing multi-year, high-volume contracts, as set forth in sub- 22 section (b), and otherwise in accordance with procurement 23 laws and regulations. 24 VerDate Sep 11 2014 23:15 Jun 11, 2020 Jkt 099200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6201 E:\BILLS\S3780.IS S3780 kjohnson on DSK79L0C42PROD with BILLS 13 •S 3780 IS (b) RESPONSIBILITY DETERMINATIONS.—For pur- 1 poses o [Text truncated for display. 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