[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 8588 Introduced in House (IH)]

<DOC>






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.

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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Improving the American Drug Supply 
Chain Act of 2020''.

SEC. 2. STUDY AND REPORTING ON DOMESTIC AND FOREIGN PRODUCTION.

    (a) In General.--The Secretary of Health and Human Services shall 
enter into an agreement with the National Academies of Sciences, 
Engineering, and Medicine (referred to in this section as the 
``National Academies'') under which, not later than 24 months after the 
date of enactment of this Act, the National Academies will--
            (1) study the current and historical production of drugs 
        and key ingredients thereof (including active pharmaceutical 
        ingredients) in the United States and in foreign countries;
            (2) formulate recommendations for promoting increased 
        production of drugs and key ingredients thereof (including 
        active pharmaceutical ingredients) in the United States; and
            (3) in a manner that does not compromise national security 
        or disclose trade secrets or other confidential commercial 
        information that is subject to section 552(b)(4) of title 5, 
        United States Code, or section 1905 of title 18, United States 
        Code, submit a report to the Congress on--
                    (A) the findings and conclusions of the study under 
                paragraph (1); and
                    (B) the recommendations under paragraph (2).
    (b) Study Topics.--The study pursuant to subsection (a)(1) shall 
include--
            (1) evaluation of--
                    (A) the extent to which production of drugs for use 
                in the United States and key ingredients thereof 
                (including active pharmaceutical ingredients) takes 
                place in the United States; and
                    (B) the extent to which such production takes place 
                in foreign countries;
            (2) identification of the foreign countries in which such 
        production takes place;
            (3) evaluation of historical changes in the countries in 
        which such production takes place;
            (4) determination of the reasons why such production takes 
        place in foreign countries, including why such production takes 
        place in particular foreign countries, including consideration 
        of--
                    (A) the reasons for historical migration of such 
                production to foreign countries, or from foreign 
                countries to other foreign countries or the United 
                States;
                    (B) economic factors, including economic 
                impediments to domestic production and incentives for 
                foreign production; and
                    (C) regulatory, intellectual property, 
                international trade, and other legal and policy 
                factors; and
            (5) evaluation of the benefits of redundancies in the 
        supply chain of drugs in the United States in the event of a 
        public health emergency.
    (c) Recommendations.--The agreement under subsection (a) shall--
            (1) provide for inclusion in the recommendations under 
        subsection (a)(2) of measures (which may include statutory, 
        regulatory, and other policy changes) that should be taken--
                    (A) to encourage the domestic production of drugs 
                for use in the United States and key ingredients 
                thereof (including active pharmaceutical ingredients); 
                or
                    (B) to otherwise reduce the risks to the 
                availability of drugs in the United States in the event 
                of a public health emergency; and
            (2) require consideration, in developing such 
        recommendations, of--
                    (A) factors affecting the production of drugs, 
                including--
                            (i) access to skilled labor;
                            (ii) the cost of raw materials, the cost of 
                        energy, and related costs;
                            (iii) taxes and other incentives; and
                            (iv) the effects of regulations; and
                    (B) the costs and consequences of implementing, or 
                failing to implement, each such recommendation.
    (d) Input.--The agreement under subsection (a) shall require--
            (1) consideration of input from the Department of Health 
        and Human Services, the Department of Commerce, and, as 
        appropriate, other Federal agencies; and
            (2) consultation with relevant stakeholders, which--
                    (A) may include conducting public meetings and 
                other forms of engagement, as appropriate;
                    (B) shall include consultation with experts in--
                            (i) the manufacturing of drugs;
                            (ii) pharmaceutical industry business and 
                        economics;
                            (iii) drug purchasing, pricing, and 
                        reimbursement;
                            (iv) regulatory and intellectual property 
                        issues affecting drug manufacturing;
                            (v) economics;
                            (vi) international trade policy; and
                            (vii) emergency planning; and
                    (C) may include consultation with other entities 
                with experience in drug manufacturing and pricing, as 
                appropriate.
    (e) Definitions.--In this section, the term ``drug'' has the 
meaning given such term in section 201 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 321).
                                 <all>