[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[S. 4542 Introduced in Senate (IS)]

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116th CONGRESS
  2d Session
                                S. 4542

To prohibit distribution abroad of COVID-19 vaccines developed with the 
support of Federal funding until the domestic need for the vaccine has 
                               been met.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                           September 9, 2020

  Mr. Tillis introduced the following bill; which was read twice and 
    referred to the Committee on Banking, Housing, and Urban Affairs

_______________________________________________________________________

                                 A BILL


 
To prohibit distribution abroad of COVID-19 vaccines developed with the 
support of Federal funding until the domestic need for the vaccine has 
                               been met.

    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 ``America First Vaccine Act''.

SEC. 2. COVID-19 VACCINE DISTRIBUTION.

    (a) Certification Requirement.--
            (1) In general.--Notwithstanding any other provision of 
        law, subject to paragraph (2), a manufacturer of a vaccine 
        described in subsection (b) that is headquartered in the United 
        States may not distribute such vaccine outside of the United 
        States unless the Secretary of Health and Human Services 
        (referred to in this section as the ``Secretary''), in 
        consultation with the Commissioner of Food and Drugs, certifies 
        that domestic need for the vaccine already has been met.
            (2) Waiver.--The Secretary may waive the certification 
        requirement under paragraph (1) with respect to a vaccine 
        described in subsection (b) and permit the distribution of such 
        vaccine outside of the United States, if the Secretary 
        determines that such waiver and distribution is in the interest 
        of the American public health.
    (b) Vaccines Described.--A vaccine described in this subsection is 
a COVID-19 vaccine that--
            (1) is authorized under section 564 of the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 360bbb-3) or licensed under 
        section 351 of the Public Health Service Act (42 U.S.C. 262); 
        and
            (2) was developed with support of Federal funding made 
        available under the Coronavirus Preparedness and Response 
        Supplemental Appropriations Act (Public Law 116-123), the 
        Families First Coronavirus Response Act (Public Law 116-127), 
        the Coronavirus Aid, Relief, and Economic Security Act (Public 
        Law 116-136), or the Paycheck Protection Program and Health 
        Care Enhancement Act (Public Law 116-139).
    (c) Violations.--In the case of a manufacturer who violates 
subsection (a), such manufacturer shall be required to reimburse the 
Federal Government for all amounts received by the manufacturer in 
support of development of the vaccine, plus interest in an amount 
determined by the Secretary of the Treasury.
    (d) Rule of Construction.--Nothing in this Act shall be construed 
to limit or otherwise restrict the Secretary's authority to enter into 
bilateral or multilateral agreements with international manufacturers 
to procure vaccines described in subsection (b) for the people of the 
United States.
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