[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 3143 Introduced in Senate (IS)]

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118th CONGRESS
  1st Session
                                S. 3143

To establish postmarket reporting requirements for pharmaceuticals, and 
                          for other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                            October 26, 2023

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

_______________________________________________________________________

                                 A BILL


 
To establish postmarket reporting requirements for pharmaceuticals, 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 ``Further Strengthening America's 
Supply Chain and National Security Act''.

SEC. 2. MODIFICATION OF RULES OF ORIGIN FOR PHARMACEUTICAL PRODUCTS.

    (a) Trade Agreements.--Section 308(4)(B) of the Trade Agreements 
Act of 1979 (19 U.S.C. 2518(4)(B)) is amended--
            (1) in clause (i), by striking ``instrumentality, or'' and 
        inserting ``instrumentality,'';
            (2) in clause (ii), by inserting ``, other than an active 
        pharmaceutical ingredient,'' after ``part of materials''; and
            (3) by striking the period at the end and inserting ``, or 
        (iii) in the case of an article which consists of an active 
        pharmaceutical ingredient, the pharmaceutical ingredient is 
        wholly the growth, product, or manufacture of that country or 
        instrumentality.''.
    (b) Federal Acquisition Regulation.--Not later than 180 days after 
the date of the enactment of this Act, the President shall prescribe 
regulations to update sections 52.225-5 and 25.003 of title 48, Code of 
Federal Regulations (or successor regulations) to be consistent with 
rules of origin determinations for active pharmaceutical ingredients 
made under section 308(4)(B) of the Trade Agreements Act of 1979 (19 
U.S.C. 2518(4)(B)), as amended by subsection (a).

SEC. 3. POSTMARKET REPORTING REQUIREMENTS FOR PHARMACEUTICALS.

    (a) In General.--The Secretary of Health and Human Services, acting 
through the Commissioner of Food and Drugs, shall ensure that each 
holder of an approved application under section 505 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355) or under section 351 of 
the Public Health Service Act (42 U.S.C. 262) annually submit, as part 
of the postmarket annual report required by the Secretary under section 
314.81(b)(2) of title 21, Code of Federal Regulations (or any successor 
regulation), the following information:
            (1) The names and addresses of the sources of active and 
        inactive ingredients of the drug.
            (2) For each active and inactive ingredient of the drug, 
        the percentage of the aggregate amount of such ingredient used 
        in the manufacture of the drug during the reporting period that 
        is from each of the sources identified under paragraph (1).
    (b) Disclosure of Information.--The Secretary of Health and Human 
Services shall--
            (1) annually provide the information reported in paragraphs 
        (1) and (2) of subsection (a) to the Secretary of Defense for 
        purposes of understanding the dependency on foreign 
        manufacturers of drugs used by members of the Armed Forces; and
            (2) publish the information reported under such paragraphs 
        on a publicly available internet website of the Federal 
        Government in a single, aggregate form, without disclosing 
        proprietary information.

SEC. 4. ADDITIONAL RISK FACTORS FOR CONSIDERATION DURING INSPECTIONS OF 
              DRUG AND DEVICE ESTABLISHMENTS.

    Section 510(h)(4) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360(h)(4)) is amended--
            (1) by redesignating subparagraph (G) as subparagraph (J); 
        and
            (2) by inserting after subparagraph (F) the following:
                    ``(G) Whether the establishment has been inspected 
                by an entity that carries out inspections on behalf of 
                a foreign government determined to be a foreign 
                adversary under section 7.4 of title 15, Code of 
                Federal Regulations (or successor regulations).
                    ``(H) The particular drugs or devices (with a focus 
                on drugs and devices included on the list of essential 
                medicines pursuant to section 3(c) of Executive Order 
                13944 (85 Fed. Reg. 49929)) manufactured, prepared, 
                propagated, compounded, or processed in the 
                establishment, with particular attention to the number 
                of other establishments globally that also manufacture, 
                prepare, propagate, compound, or process the same drug 
                or device from which the United States sources such 
                drug or device.
                    ``(I) Whether the establishment is located in a 
                country with a history or 1 or more previous instances 
                of exporting illicit drugs or precursor chemicals to 
                the United States, as determined by the Secretary by 
                reference to the most recent report submitted to 
                Congress pursuant to section 489 of the Foreign 
                Assistance Act of 1961.''.
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