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[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 2683 Introduced in Senate (IS)]

<DOC>

118th CONGRESS
  1st Session
                                S. 2683

  To establish requirements for purchasing certain generic drugs from 
            manufacturers who produce the drug domestically.

_______________________________________________________________________

                   IN THE SENATE OF THE UNITED STATES

                             July 27, 2023

  Mr. Scott of Florida introduced the following bill; which was read 
 twice and referred to the Committee on Health, Education, Labor, and 
                                Pensions

_______________________________________________________________________

                                 A BILL

 
  To establish requirements for purchasing certain generic drugs from 
            manufacturers who produce the drug domestically.

    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 ``Accelerating Movement of Essential 
Rx Items to Create Access to National Drug Resources for US Government 
Services Act'' or the ``AMERICAN DRUGS Act''.

SEC. 2. FDA NOTIFICATION.

    (a) In General.--The Secretary of Health and Human Services, acting 
through the Commissioner of Food and Drugs (referred to in this section 
as the ``Commissioner''), shall issue notifications to the 
Administrator of the Centers for Medicare & Medicaid Services, the 
Secretary of Defense, and the Secretary of Veterans Affairs upon a 
determination by the Commissioner that--
            (1) there are at least 2 approved generic drugs that are 
        manufactured domestically, as described in subsection (b), each 
        of which--
                    (A) is approved pursuant to an application under 
                section 505(j) of the Federal Food, Drug, and Cosmetic 
                Act (21 U.S.C. 355(j)); and
                    (B) references the same listed drug under paragraph 
                (7) of such section 505(j); or
            (2) there are fewer than 2 approved generic drugs that are 
        manufactured domestically--
                    (A) approved pursuant to an application under 
                section 505(j) of the Federal Food, Drug, and Cosmetic 
                Act (21 U.S.C. 355(j)); and
                    (B) that reference the same listed drug under 
                paragraph (7) of such section 505(j) as another drug 
                approved under such section 505(j);
            (3) paragraph (1)(B) may soon apply because the 
        Commissioner has been notified that a holder of an approved 
        application for a generic drug that is manufactured 
        domestically, as described in subsection (b), plans to 
        discontinue manufacturing, or expects an interruption of the 
        manufacture of, such drug at an establishment described in 
        subsection (b)(1)(B); or
            (4) a generic drug that is manufactured domestically, as 
        described in subsection (b), is in shortage, as defined in 
        section 506C(h)(2) of the Federal Food, Drug, and Cosmetic Act 
        (21 U.S.C. 356c(h)(2)).
    (b) Generic Drug Manufactured Domestically Described.--In this 
section, a generic drug that is manufactured domestically--
            (1) is a drug--
                    (A) that is approved under section 505(j) of the 
                Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
                355(j)); and
                    (B) for which there is at least one establishment 
                registered under section 510(b)(1) of the Federal Food, 
                Drug, and Cosmetic Act (21 U.S.C. 360(b)(1)) engaged in 
                the manufacture of the finished dosage form of the 
                drug; and
            (2) excludes any authorized generic drug, as defined in 
        section 505(t)(3) of the Federal Food, Drug, and Cosmetic Act 
        (21 U.S.C. 355(t)(3)).
    (c) Special Rule Concerning Generic Drugs in Shortage.--A 
notification under subsection (a)(4) that a generic drug that is 
manufactured domestically, as described in subsection (b), is in 
shortage, shall apply only for--
            (1) an initial period of not more than 90 days; and
            (2) such additional 30-day renewal periods as the Secretary 
        of Health and Human Services may indicate by--
                    (A) submitting to Congress a notification of intent 
                to renew the notification under subsection (a)(4); and
                    (B) publicly posting information about the 
                shortage, the steps the Food and Drug Administration is 
                taking to address the shortage, and an estimated date 
                by which the shortage is expected to be resolved.

SEC. 3. EXPEDITED CONSIDERATION OF CERTAIN ABBREVIATED NEW DRUG 
              APPLICATIONS.

    Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
351 et seq.) is amended by inserting after section 506L the following:

``SEC. 506M. EXPEDITED CONSIDERATION OF CERTAIN ABBREVIATED NEW DRUG 
              APPLICATIONS.

    ``(a) In General.--The Secretary may, at the request of a sponsor 
of an application for an applicable drug, expedite the development and 
review of an abbreviated new drug application under section 505(j) for 
such drug.
    ``(b) Applicable Drug.--For purposes of this section, an applicable 
drug is a drug for which there are fewer than 2 drugs approved under 
section 505(j) that are manufactured domestically, as described in 
paragraph (2), each of which is approved pursuant to an application 
under section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355(j)) and references the same listed drug under paragraph (7) 
of such section 505(j).
    ``(c) Actions.--In expediting the development and review of an 
application under subsection (a), the Secretary may, as requested by 
the applicant, take actions including the following:
            ``(1) Hold meetings with the applicant and the review team 
        throughout the development of the drug prior to submission of 
        the application for such drug under section 505(j).
            ``(2) Provide timely advice to, and interactive 
        communication with, the applicant regarding the development of 
        the drug to ensure that the development program to gather the 
        data necessary for approval is as efficient as practicable.
            ``(3) Involve senior managers and experienced review staff, 
        as appropriate, in a collaborative, coordinated review of such 
        application, including with respect to drug-device combination 
        products and other complex products.
            ``(4) Assign a cross-disciplinary project lead--
                    ``(A) to facilitate an efficient review of the 
                development program and application, including 
                manufacturing inspections; and
                    ``(B) to serve as a scientific liaison between the 
                review team and the applicant.
    ``(d) Reporting Requirement.--Not later than one year after the 
date of the approval of an application under section 505(j) with 
respect to a drug for which the development and review is expedited 
under this section, the sponsor of such drug shall report to the 
Secretary on whether the drug has been marketed in interstate commerce 
since the date of such approval.''.

SEC. 4. PROHIBITION OF PAYMENT UNDER MEDICARE PART B OR COVERAGE UNDER 
              MEDICARE PART D FOR CERTAIN GENERIC DRUGS MANUFACTURED 
              OUTSIDE OF THE UNITED STATES.

    (a) Medicare Part B.--Section 1842(o) of the Social Security Act 
(42 U.S.C. 1395u(o)) is amended by adding at the end the following new 
paragraph:
    ``(9)(A) Payment shall only be made under this part for a generic 
drug furnished on or after January 1, 2025, if it is a generic drug 
manufactured domestically (as described in section 2(b) of the 
Accelerating Movement of Essential Rx Items to Create Access to 
National Drug Resources for US Government Services Act).
    ``(B) Subparagraph (A) shall not apply, with respect to a drug, 
during any period for which the Secretary--
            ``(i) has notified the Administrator of the Centers for 
        Medicare & Medicaid Services pursuant to section 2(a) of the 
        Accelerating Movement of Essential Rx Items to Create Access to 
        National Drug Resources for US Government Services Act that the 
        circumstances under paragraph (2), (3), or (4) of such section 
        apply; or
            ``(ii) otherwise determines that access to the drug is 
        essential to the health of beneficiaries under this part.''.
    (b) Medicare Part D.--Section 1860D-42 of the Social Security Act 
(42 U.S.C. 1395w-152) is amended by adding at the end the following new 
subsection:
    ``(e) Prohibition of Coverage for Certain Generic Drugs 
Manufactured Outside of the United States.--
            ``(1) In general.--Coverage shall only be available under 
        this part for a covered part D drug that is a generic drug 
        dispensed on or after January 1, 2025, if it is a generic drug 
        manufactured domestically (as described in section 2(b) of the 
        Accelerating Movement of Essential Rx Items to Create Access to 
        National Drug Resources for US Government Services Act).
            ``(2) Exceptions.--Paragraph (1) shall not apply, with 
        respect to a covered part D drug, during any period for which 
        the Secretary--
                    ``(A) has notified the Administrator of the Centers 
                for Medicare & Medicaid Services pursuant to section 
                2(a) of the Accelerating Movement of Essential Rx Items 
                to Create Access to National Drug Resources for US 
                Government Services Act that the circumstances under 
                paragraph (2), (3), or (4) of such section apply; or
                    ``(B) otherwise determines that access to the drug 
                is essential to the health of beneficiaries under this 
                part.''.

SEC. 5. PROHIBITION OF PAYMENT UNDER MEDICAID AND CHIP FOR CERTAIN 
              GENERIC DRUGS MANUFACTURED OUTSIDE OF THE UNITED STATES.

    (a) Medicaid.--Title XIX of the Social Security Act (42 U.S.C. 1396 
et seq.) is amended--
            (1) in section 1903(i)(10)--
                    (A) in subparagraph (D), by striking ``; and'' and 
                inserting a semicolon;
                    (B) in subparagraph (E), by striking ``; or'' and 
                inserting ``; and''; and
                    (C) by inserting after subparagraph (E) the 
                following new subparagraph:
            ``(F) with respect to any amount expended for a covered 
        outpatient drug which the State is required to exclude from 
        coverage under section 1927(d)(8); or''; and
            (2) in section 1927(d), by adding at the end the following 
        new paragraph:
            ``(8) Restriction on coverage of foreign-made generic 
        drugs.--
                    ``(A) In general.--Beginning January 1, 2025, a 
                State shall exclude coverage of a foreign-made generic 
                covered outpatient drug if there is a generic drug that 
                is manufactured domestically (as described in section 
                2(b) of the Accelerating Movement of Essential Rx Items 
                to Create Access to National Drug Resources for US 
                Government Services Act) that references the same 
                listed drug under section 505(j)(7) of the Federal 
                Food, Drug, and Cosmetic Act as the foreign-made 
                generic covered outpatient drug.
                    ``(B) Definition of foreign-made generic covered 
                outpatient drug.--For purposes of this paragraph, the 
                term `foreign-made generic covered outpatient drug' 
                means a covered outpatient drug that--
                            ``(i) is approved under section 505(j) of 
                        the Federal Food, Drug, and Cosmetic Act; and
                            ``(ii) is not a generic drug that is 
                        manufactured domestically (as described in 
                        section 2(b) of the Accelerating Movement of 
                        Essential Rx Items to Create Access to National 
                        Drug Resources for US Government Services Act).
                    ``(C) Exceptions.--Subparagraph (A) shall not apply 
                to a foreign-made generic covered outpatient drug 
                during any period for which the Secretary--
                            ``(i) has notified the Administrator of the 
                        Centers for Medicare & Medicaid Services 
                        pursuant to section 2(a) of the Accelerating 
                        Movement of Essential Rx Items to Create Access 
                        to National Drug Resources for US Government 
                        Services Act that the circumstances under 
                        paragraph (2), (3), or (4) of such section 
                        apply with respect to such drug; or
                            ``(ii) otherwise determines that access to 
                        the foreign-made generic covered outpatient 
                        drug is essential to the health of individuals 
                        enrolled for medical assistance under this 
                        title.
                    ``(D) Notice to states.--The Secretary shall 
                provide notice to States if a foreign-made generic 
                covered outpatient drug is subject to exclusion from 
                coverage under this paragraph.''.
    (b) CHIP.--Section 2107(e)(1)(M) of the Social Security Act (42 
U.S.C. 1397gg(e)(1)(M)) is amended by inserting ``(10)(F),'' after 
``(2),''.

SEC. 6. PROCUREMENT BY DEPARTMENT OF VETERANS AFFAIRS OF GENERIC DRUGS 
              MANUFACTURED DOMESTICALLY.

    (a) In General.--Subchapter II of chapter 81 of title 38, United 
States Code, is amended by inserting after section 8126 the following 
new section:
``Sec. 8126A. Procurement of generic drugs manufactured domestically
    ``(a) In General.--Subject to subsection (b), the Secretary may 
only procure a generic drug if it is a generic drug manufactured 
domestically, as described in section 2(b) of the Accelerating Movement 
of Essential Rx Items to Create Access to National Drug Resources for 
US Government Services Act.
    ``(b) Exceptions.--Subsection (a) shall not apply with respect to a 
drug during any period for which--
            ``(1) the Secretary of Health and Human Services has 
        notified the Secretary of Veterans Affairs pursuant to section 
        2(a) of the Accelerating Movement of Essential Rx Items to 
        Create Access to National Drug Resources for US Government 
        Services Act that the circumstances under paragraph (2), (3), 
        or (4) of such section apply; or
            ``(2) the Secretary of Veterans Affairs determines that 
        access to the drug is essential to the health of beneficiaries 
        under the laws administered by the Secretary.''.
    (b) Clerical Amendment.--The table of sections at the beginning of 
such subchapter is amended by inserting after the item relating to 
section 8126 the following new item:

``8126A. Procurement of generic drugs manufactured domestically.''.
    (c) Effective Date.--The amendments made by this section shall take 
effect on January 1, 2025.

SEC. 7. PROCUREMENT BY DEPARTMENT OF DEFENSE OF GENERIC DRUGS 
              MANUFACTURED DOMESTICALLY.

    (a) In General.--Chapter 55 of title 10, United States Code, is 
amended by inserting after section 1074g the following new section:
``Sec. 1074g-1. Procurement of generic drugs manufactured domestically
    ``(a) In General.--Subject to subsection (b), the Secretary of 
Defense may only procure a generic drug if it is a generic drug 
manufactured domestically, as described in section 2(b) of the 
Accelerating Movement of Essential Rx Items to Create Access to 
National Drug Resources for US Government Services Act.
    ``(b) Exceptions.--Subsection (a) shall not apply with respect to a 
drug during any period for which--
            ``(1) the Secretary of Health and Human Services has 
        notified the Secretary of Defense pursuant to section 2(a) of 
        the Accelerating Movement of Essential Rx Items to Create 
        Access to National Drug Resources for US Government Services 
        Act that the circumstances under paragraph (2), (3), or (4) of 
        such section apply; or
            ``(2) the Secretary of Defense determines that access to 
        the drug is essential to the health of beneficiaries under the 
        TRICARE program.''.
    (b) Clerical Amendment.--The table of sections at the beginning of 
such chapter is amended by inserting after the item relating to section 
1074g the following new item:

``1074g-1. Procurement of generic drugs manufactured domestically.''.
    (c) Effective Date.--The amendments made by this section shall take 
effect on January 1, 2025.
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