Improving the American Drug Supply Chain Act of 2020

I 116TH CONGRESS 2D SESSION H. R. 8588 To provide for a study on the current and historical production of drugs in the United States and in foreign countries, and for other purposes. IN THE HOUSE OF REPRESENTATIVES OCTOBER 13, 2020 Mr. HUDSON (for himself and Ms. BLUNT ROCHESTER) introduced the fol- lowing bill; which was referred to the Committee on Energy and Com- merce, and in addition to the Committee on Foreign Affairs, for a period to be subsequently determined by the Speaker, in each case for consider- ation of such provisions as fall within the jurisdiction of the committee concerned A BILL To provide for a study on the current and historical produc- tion of drugs in the United States and in foreign coun- tries, 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 ‘‘Improving the Amer- 4 ican Drug Supply Chain Act of 2020’’. 5 VerDate Sep 11 2014 23:13 Oct 31, 2020 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H8588.IH H8588 pbinns on DSKJLVW7X2PROD with BILLS 2 •HR 8588 IH SEC. 2. STUDY AND REPORTING ON DOMESTIC AND FOR- 1 EIGN PRODUCTION. 2 (a) IN GENERAL.—The Secretary of Health and 3 Human Services shall enter into an agreement with the 4 National Academies of Sciences, Engineering, and Medi- 5 cine (referred to in this section as the ‘‘National Acad- 6 emies’’) under which, not later than 24 months after the 7 date of enactment of this Act, the National Academies 8 will— 9 (1) study the current and historical production 10 of drugs and key ingredients thereof (including ac- 11 tive pharmaceutical ingredients) in the United 12 States and in foreign countries; 13 (2) formulate recommendations for promoting 14 increased production of drugs and key ingredients 15 thereof (including active pharmaceutical ingredients) 16 in the United States; and 17 (3) in a manner that does not compromise na- 18 tional security or disclose trade secrets or other con- 19 fidential commercial information that is subject to 20 section 552(b)(4) of title 5, United States Code, or 21 section 1905 of title 18, United States Code, submit 22 a report to the Congress on— 23 (A) the findings and conclusions of the 24 study under paragraph (1); and 25 VerDate Sep 11 2014 23:13 Oct 31, 2020 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H8588.IH H8588 pbinns on DSKJLVW7X2PROD with BILLS 3 •HR 8588 IH (B) the recommendations under paragraph 1 (2). 2 (b) STUDY TOPICS.—The study pursuant to sub- 3 section (a)(1) shall include— 4 (1) evaluation of— 5 (A) the extent to which production of 6 drugs for use in the United States and key in- 7 gredients thereof (including active pharma- 8 ceutical ingredients) takes place in the United 9 States; and 10 (B) the extent to which such production 11 takes place in foreign countries; 12 (2) identification of the foreign countries in 13 which such production takes place; 14 (3) evaluation of historical changes in the coun- 15 tries in which such production takes place; 16 (4) determination of the reasons why such pro- 17 duction takes place in foreign countries, including 18 why such production takes place in particular for- 19 eign countries, including consideration of— 20 (A) the reasons for historical migration of 21 such production to foreign countries, or from 22 foreign countries to other foreign countries or 23 the United States; 24 VerDate Sep 11 2014 23:13 Oct 31, 2020 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H8588.IH H8588 pbinns on DSKJLVW7X2PROD with BILLS 4 •HR 8588 IH (B) economic factors, including economic 1 impediments to domestic production and incen- 2 tives for foreign production; and 3 (C) regulatory, intellectual property, inter- 4 national trade, and other legal and policy fac- 5 tors; and 6 (5) evaluation of the benefits of redundancies in 7 the supply chain of drugs in the United States in 8 the event of a public health emergency. 9 (c) RECOMMENDATIONS.—The agreement under sub- 10 section (a) shall— 11 (1) provide for inclusion in the recommenda- 12 tions under subsection (a)(2) of measures (which 13 may include statutory, regulatory, and other policy 14 changes) that should be taken— 15 (A) to encourage the domestic production 16 of drugs for use in the United States and key 17 ingredients thereof (including active pharma- 18 ceutical ingredients); or 19 (B) to otherwise reduce the risks to the 20 availability of drugs in the United States in the 21 event of a public health emergency; and 22 (2) require consideration, in developing such 23 recommendations, of— 24 VerDate Sep 11 2014 23:13 Oct 31, 2020 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H8588.IH H8588 pbinns on DSKJLVW7X2PROD with BILLS 5 •HR 8588 IH (A) factors affecting the production of 1 drugs, including— 2 (i) access to skilled labor; 3 (ii) the cost of raw materials, the cost 4 of energy, and related costs; 5 (iii) taxes and other incentives; and 6 (iv) the effects of regulations; and 7 (B) the costs and consequences of imple- 8 menting, or failing to implement, each such rec- 9 ommendation. 10 (d) INPUT.—The agreement under subsection (a) 11 shall require— 12 (1) consideration of input from the Department 13 of Health and Human Services, the Department of 14 Commerce, and, as appropriate, other Federal agen- 15 cies; and 16 (2) consultation with relevant stakeholders, 17 which— 18 (A) may include conducting public meet- 19 ings and other forms of engagement, as appro- 20 priate; 21 (B) shall include consultation with experts 22 in— 23 (i) the manufacturing of drugs; 24 VerDate Sep 11 2014 03:59 Nov 04, 2020 Jkt 019200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H8588.IH H8588 pbinns on DSKJLVW7X2PROD with BILLS 6 •HR 8588 IH (ii) pharmaceutical industry business 1 and economics; 2 (iii) drug purchasing, pricing, and re- 3 imbursement; 4 (iv) regulatory and intellectual prop- 5 erty issues affecting drug manufacturing; 6 (v) economics; 7 (vi) international trade policy; and 8 (vii) emergency planning; and 9 (C) may include consultation with other 10 entities with experience in drug manufacturing 11 and pricing, as appropriate. 12 (e) DEFINITIONS.—In this section, the term ‘‘drug’’ 13 has the meaning given such term in section 201 of the 14 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321). 15 Æ VerDate Sep 11 2014 23:13 Oct 31, 2020 Jkt 019200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6301 E:\BILLS\H8588.IH H8588 pbinns on DSKJLVW7X2PROD with BILLS