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 following bill; which was referred to the Committee on Energy and Commerce, and in addition to the Committee on Foreign Affairs, for a period 

to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee 

concerned 

A BILL 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Improving the Amer5 ican Drug Supply Chain Act of 2020’’. 


pbinns on DSKJLVW7X2PROD with BILLS
2 

•HR 8588 IH

1 SEC. 2. STUDY AND REPORTING ON DOMESTIC AND FOR2 EIGN PRODUCTION. 

3 (a) IN GENERAL.—The Secretary of Health and 

4 Human Services shall enter into an agreement with the 

5 National Academies of Sciences, Engineering, and Medi6 cine (referred to in this section as the ‘‘National Acad7 emies’’) under which, not later than 24 months after the 

8 date of enactment of this Act, the National Academies 

9 will— 

10 (1) study the current and historical production 

11 of drugs and key ingredients thereof (including ac12 tive pharmaceutical ingredients) in the United 

13 States and in foreign countries; 

14 (2) formulate recommendations for promoting 

15 increased production of drugs and key ingredients 

16 thereof (including active pharmaceutical ingredients) 

17 in the United States; and 

18 (3) in a manner that does not compromise na19 tional security or disclose trade secrets or other con20 fidential commercial information that is subject to 

21 section 552(b)(4) of title 5, United States Code, or 

22 section 1905 of title 18, United States Code, submit 

23 a report to the Congress on— 

24 (A) the findings and conclusions of the 

25 study under paragraph (1); and 


pbinns on DSKJLVW7X2PROD with BILLS
3 

•HR 8588 IH

1 (B) the recommendations under paragraph 

2 (2). 

3 (b) STUDY TOPICS.—The study pursuant to sub4 section (a)(1) shall include— 

5 (1) evaluation of— 

6 (A) the extent to which production of 

7 drugs for use in the United States and key in8 gredients thereof (including active pharma9 ceutical ingredients) takes place in the United 

10 States; and 

11 (B) the extent to which such production 

12 takes place in foreign countries; 

13 (2) identification of the foreign countries in 

14 which such production takes place; 

15 (3) evaluation of historical changes in the coun16 tries in which such production takes place; 

17 (4) determination of the reasons why such pro18 duction takes place in foreign countries, including 

19 why such production takes place in particular for20 eign countries, including consideration of— 

21 (A) the reasons for historical migration of 

22 such production to foreign countries, or from 

23 foreign countries to other foreign countries or 

24 the United States; 


pbinns on DSKJLVW7X2PROD with BILLS
4 

•HR 8588 IH

1 (B) economic factors, including economic 

2 impediments to domestic production and incen3 tives for foreign production; and 

4 (C) regulatory, intellectual property, inter5 national trade, and other legal and policy fac6 tors; and 

7 (5) evaluation of the benefits of redundancies in 

8 the supply chain of drugs in the United States in 

9 the event of a public health emergency. 

10 (c) RECOMMENDATIONS.—The agreement under sub11 section (a) shall— 

12 (1) provide for inclusion in the recommenda13 tions under subsection (a)(2) of measures (which 

14 may include statutory, regulatory, and other policy 

15 changes) that should be taken— 

16 (A) to encourage the domestic production 

17 of drugs for use in the United States and key 

18 ingredients thereof (including active pharma19 ceutical ingredients); or 

20 (B) to otherwise reduce the risks to the 

21 availability of drugs in the United States in the 

22 event of a public health emergency; and 

23 (2) require consideration, in developing such 

24 recommendations, of— 


pbinns on DSKJLVW7X2PROD with BILLS
5 

•HR 8588 IH

1 (A) factors affecting the production of 

2 drugs, including— 

3 (i) access to skilled labor; 

4 (ii) the cost of raw materials, the cost 

5 of energy, and related costs; 

6 (iii) taxes and other incentives; and 

7 (iv) the effects of regulations; and 

8 (B) the costs and consequences of imple9 menting, or failing to implement, each such rec10 ommendation. 

11 (d) INPUT.—The agreement under subsection (a) 

12 shall require— 

13 (1) consideration of input from the Department 

14 of Health and Human Services, the Department of 

15 Commerce, and, as appropriate, other Federal agen16 cies; and 

17 (2) consultation with relevant stakeholders, 

18 which— 

19 (A) may include conducting public meet20 ings and other forms of engagement, as appro21 priate; 

22 (B) shall include consultation with experts 

23 in— 

24 (i) the manufacturing of drugs; 


pbinns on DSKJLVW7X2PROD with BILLS
6 

•HR 8588 IH

1 (ii) pharmaceutical industry business 

2 and economics; 

3 (iii) drug purchasing, pricing, and re4 imbursement; 

5 (iv) regulatory and intellectual prop6 erty issues affecting drug manufacturing; 

7 (v) economics; 

8 (vi) international trade policy; and 

9 (vii) emergency planning; and 

10 (C) may include consultation with other 

11 entities with experience in drug manufacturing 

12 and pricing, as appropriate. 

13 (e) DEFINITIONS.—In this section, the term ‘‘drug’’ 

14 has the meaning given such term in section 201 of the 

15 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321). 

Æ 


pbinns on DSKJLVW7X2PROD with BILLS