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[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 5419 Introduced in Senate (IS)]

<DOC>

118th CONGRESS
  2d Session
                                S. 5419

  To require the Secretary of Health and Human Services to maintain a 
list of the country of origin of certain critical drugs marketed in the 
                 United States, and for other purposes.

_______________________________________________________________________

                   IN THE SENATE OF THE UNITED STATES

                            December 4, 2024

 Mr. Cotton (for himself and Mr. Kaine) introduced the following bill; 
     which was read twice and referred to the Committee on Health, 
                     Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL

 
  To require the Secretary of Health and Human Services to maintain a 
list of the country of origin of certain critical drugs marketed in the 
                 United States, 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 ``Protecting Our Essential Medicines 
Act''.

SEC. 2. LIST OF CRITICAL DRUGS PRODUCED OUTSIDE THE UNITED STATES.

    Subchapter A of chapter V of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 351 et seq.) is amended by adding at the end the 
following:

``SEC. 524C. LIST OF CRITICAL DRUGS PRODUCED OUTSIDE THE UNITED STATES.

    ``(a) List of Critical Drugs.--
            ``(1) In general.--For purposes of strengthening the public 
        health supply chain and industrial base, and increasing the 
        manufacture of essential drugs, including biological products, 
        and critical inputs of such drugs in the United States, the 
        Secretary shall compile and maintain a list of each drug that 
        is--
                    ``(A) approved under subsection (c) or (j) of 
                section 505 of this Act or licensed under subsection 
                (a) or (k) of section 351 of the Public Health Service 
                Act;
                    ``(B) imported into the United States; and
                    ``(C)(i) determined by the interagency task force 
                established under subsection (e) to be critical to the 
                health and safety of consumers in the United States;
                    ``(ii) determined by such task force to be a drug 
                the shortage of which would have an adverse health 
                outcome on patients with chronic conditions; or
                    ``(iii) a qualified countermeasure, as defined in 
                section 319F-1(a)(2) of the Public Health Service Act, 
                a qualified pandemic or epidemic product, as defined in 
                section 319F-3(i) of such Act, or a security 
                countermeasure, as defined in section 319F-2(c) of such 
                Act.
            ``(2) Supply chain information.--The list required by 
        paragraph (1) shall, with respect to each drug included on the 
        list, provide information about each facility registered under 
        section 510 that is involved in the manufacture, preparation, 
        propagation, compounding, or processing of the drug or an 
        ingredient of the drug.
            ``(3) No public disclosure.--The list required by paragraph 
        (1), and any portion thereof, shall not be publicly disclosed, 
        and nothing in paragraph (1) or (2) shall be construed as 
        authorizing the Secretary to disclose any information that is a 
        trade secret or confidential information subject to section 
        552(b)(4) of title 5, United States Code, or section 1905 of 
        title 18, United States Code.
            ``(4) Permissible disclosure to national security agencies 
        of the federal government.--The list required by paragraph (1) 
        (and any portion thereof) may be disclosed by the Secretary 
        only--
                    ``(A) within the Department of Health and Human 
                Services and pursuant to reporting under subsection 
                (e); and
                    ``(B) for purposes of evaluating supply chain 
                vulnerabilities and other national security issues, 
                with national security agencies of the Federal 
                Government, including all elements of the Department of 
                Defense and national intelligence agencies.
            ``(5) Definition.--In this subsection, the term `critical 
        inputs' means active pharmaceutical ingredients, starting 
        material for active pharmaceutical ingredients, and other 
        ingredients of drugs that the Commissioner of Food and Drugs 
        determines to be critical in assessing the safety and 
        effectiveness of drugs described in paragraph (1).
    ``(b) Additional Lists.--
            ``(1) In general.--In conjunction with the list under 
        subsection (a), the Secretary shall, in consultation with the 
        interagency task force established under subsection (e), 
        compile and maintain--
                    ``(A) a list of drugs included on the list under 
                subsection (a) that are exclusively produced in, or use 
                active pharmaceutical ingredients produced in, a 
                foreign entity of concern (as defined in section 
                9901(8) of the William M. (Mac) Thornberry National 
                Defense Authorization Act for Fiscal Year 2021); and
                    ``(B) a list identifying the top 3 countries from 
                which the United States imports drugs described in 
                subsection (a)(1).
            ``(2) Disclosure.--
                    ``(A) List of drugs.--
                            ``(i) No public disclosure.--The list 
                        required by paragraph (1)(A) (and any portion 
                        thereof) shall not be publicly disclosed.
                            ``(ii) Permissible disclosure to national 
                        security agencies of the federal government.--
                        The list required by paragraph (1)(A), and any 
                        portion thereof, may be disclosed by the 
                        Secretary only--
                                    ``(I) within the Department of 
                                Health and Human Services, and pursuant 
                                to reporting under subsection (f); and
                                    ``(II) for purposes of evaluating 
                                supply chain vulnerabilities and other 
                                national security issues, with national 
                                security agencies of the Federal 
                                Government.
                    ``(B) List of top 3 countries.--The Secretary shall 
                publicly disclose the list required by paragraph 
                (1)(B), but may not include in any such disclosure--
                            ``(i) information about an identifiable 
                        drug or active pharmaceutical ingredient; or
                            ``(ii) proprietary information regarding a 
                        drug or active pharmaceutical ingredient, 
                        including information that is a trade secret or 
                        confidential information subject to section 
                        552(b)(4) of title 5, United States Code, or 
                        section 1905 of title 18, United States Code.
    ``(c) Timelines.--
            ``(1) Initial list.--The Secretary shall compile the 
        initial lists of drugs under subsections (a) and (b) not later 
        than 180 days after the date of enactment of the Protecting Our 
        Essential Medicines Act.
            ``(2) Updates.--The Secretary shall update the lists of 
        drugs under subsections (a) and (b), as the Secretary 
        determines necessary and appropriate, and not less frequently 
        than every 2 years.
    ``(d) Cybersecurity Measures.-- Prior to sharing of any lists 
required by subsection (a) or (b), within the Department of Health and 
Human Services or to national security agencies, the Secretary shall 
ensure that robust cybersecurity measures are in place to prevent 
inappropriate access to, or unauthorized disclosure of, the list or any 
information related to the list.
    ``(e) Interagency Task Force.--
            ``(1) Establishment.--Not later than 30 days after the date 
        of enactment of the Protecting Our Essential Medicines Act, the 
        Secretary shall establish an interagency task force for 
        purposes of identifying drugs to include in the list of 
        critical drugs, as described in subsection (a)(1)(C) and 
        consulting with the Secretary with respect to compiling, 
        maintaining, and updating the list under subsection (b). The 
        task force shall be comprised of representatives of the Federal 
        Government as the Secretary, in consultation with the 
        Commissioner of Food and Drugs, the Director of the Centers for 
        Disease Control and Prevention, the Secretary of Defense, the 
        Assistant Secretary for Preparedness and Response, the 
        Secretary of Homeland Security, the Commissioner of U.S. 
        Customs and Border Protection, and the Director of National 
        Intelligence, determines appropriate.
            ``(2) Procedures.--Not later than 60 days after the date of 
        enactment of the Protecting Our Essential Medicines Act, the 
        task force established under paragraph (1) shall submit a 
        report on the procedures such task force will follow in making 
        determinations with respect to drugs as described in clauses 
        (i) and (ii) of subsection (a)(1)(C) to--
                    ``(A) the Committee on Health, Education, Labor, 
                and Pensions, the Committee on Finance, and the 
                Committee on Armed Services of the Senate; and
                    ``(B) the Committee on Energy and Commerce, the 
                Committee on Ways and Means, and the Committee on Armed 
                Services of the House of Representatives.
    ``(f) Reporting.--Upon compiling the initial list of drugs as 
required under subsections (a) and (b), and upon making each update to 
such lists as described in subsection (c)(2), the Secretary shall 
submit the list of drugs to--
            ``(1) the Secretary of Defense;
            ``(2) the Attorney General; and
            ``(3) the Director of National Intelligence.''.
                                 <all>
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