Securing America’s Pharmaceutical Supply Chain Act
Bill: H.R.3683 | Sponsor: Rep. Stauber, Pete (R-MN)
Policy area: Government Operations and Politics

Summary:
Securing America's Pharmaceutical Supply Chain Act
This bill allows an executive agency to purchase a drug approved or licensed by the Food and Drug Administration only if the drug is over 50% sourced, manufactured, and assembled in the United States.
This requirement may be waived (1) if the drug is not available in sufficient quantity or quality as over 50% sourced, manufactured, and assembled in the United States; or (2) during an emergency.
The U.S. Trade Representative (USTR) shall modify U.S. product coverage under all free trade agreements and the World Trade Organization Agreement on Government Procurement to exclude coverage of essential medicines and medical countermeasures. Subsequent to such modifications, the USTR shall make any necessary corresponding modifications of existing waivers and notify the Office of Management and Budget.

To require executive agencies to purchase pharmaceuticals from 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 ``Securing America's Pharmaceutical 
Supply Chain Act''.

SEC. 2. REQUIREMENT TO PURCHASE PHARMACEUTICALS FROM THE UNITED STATES.

    (a) In General.--Except as provided in subsection (b), the head of 
an executive agency may only purchase a covered drug if the drug is 
over 50-percent sourced, manufactured, and assembled in the United 
States.
    (b) Exception.--The head of an executive agency may waive the 
requirement of subsection (a)--
            (1) if the covered drug is not available in sufficient 
        quantity or quality as over 50-percent sourced, manufactured, 
        and assembled in the United States; or
            (2) during an emergency period (as defined in section 
        1135(g)(1)(A) of the Social Security Act (42 U.S.C. 1320b-
        5(g)(1)(A))).
    (c) Modifications to Trade Agreements.--
            (1) In general.--Not later than 30 days after the date of 
        the enactment of this Act, the United States Trade 
        Representative shall modify United States product coverage 
        under all free trade agreements and the World Trade 
        Organization Agreement on Government Procurement to exclude 
        coverage of essential medicines and medical countermeasures.
            (2) Modification of waivers.--Subsequent to the 
        modifications made under paragraph (1), the United States Trade 
        Representative shall make any necessary corresponding 
        modifications of existing waivers under section 301 of the 
        Trade Agreements Act of 1979 (19 U.S.C. 2511).
            (3) Notification to the president.--Subsequent to the 
        modifications made under paragraphs (1) or (2), the United 
        States Trade Representative shall notify the Director of the 
        Office of Management and Budget.
    (d) Definitions.--In this section:
            (1) Covered drug.--The term ``covered drug'' means a drug 
        (including the active pharmaceutical ingredients thereof) 
        marketed in the United States pursuant to an approval or 
        licensure under subsection (c) or (j) of section 505 of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) or under 
        subsection (a) or (k) of section 351 of the Public Health 
        Service Act (42 U.S.C. 262).
            (2) Executive agency.--The term ``executive agency'' has 
        the meaning given that term in section 133 of title 41, United 
        States Code.
            (3) United states.--The term ``United States'' means each 
        of the several States, the District of Columbia, and each 
        territory or possession of the United States.
    (e) Severability Clause.--If any provision of this Act (or the 
application of that provision to particular persons or circumstances) 
is held invalid, the remainder of this Act (or the application of that 
provision to other persons or circumstances) shall not be affected.
    (f) Effective Date.--The provisions of this section shall apply 
beginning on the date that is one year after the last day of the 
emergency period (as defined in paragraph (1)(B) of section 1135(g) of 
the Social Security Act (42 U.S.C. 1320b-5(g)).
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