[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4388 Introduced in House (IH)]
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119th CONGRESS
1st Session
H. R. 4388
To repeal sections 319F-3 and 319F-4 of the Public Health Service Act,
and for other purposes.
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IN THE HOUSE OF REPRESENTATIVES
July 15, 2025
Mr. Massie (for himself and Mr. Gosar) introduced the following bill;
which was referred to the Committee on Energy and Commerce
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A BILL
To repeal sections 319F-3 and 319F-4 of the Public Health Service Act,
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 ``PREP Repeal Act''.
SEC. 2. FINDINGS.
Congress finds the following:
(1) Liability shields granted under section 319F-3 of the
Public Health Service Act (42 U.S.C. 247d-6d) have undermined
public trust and accountability during public health
emergencies.
(2) The ability of citizens to seek redress for injury or
harm is a fundamental principle of justice and due process.
(3) The Public Readiness and Emergency Preparedness Act
(Public Law 109-148) (commonly referred to as the ``PREP Act'')
has enabled regulatory capture and legal immunity for
pharmaceutical manufacturers at the expense of individual
rights.
SEC. 3. REPEAL OF LIABILITY IMMUNITY FOR PANDEMIC PRODUCTS.
(a) Repeals.--The following sections are repealed:
(1) Section 319F-3 of the Public Health Service Act (42
U.S.C. 247d-6d).
(2) Section 319F-4 of the Public Health Service Act (42
U.S.C. 247d-6e).
(b) Rescission.--The unobligated balances of amounts in the Covered
Countermeasure Process Fund, as established by section 319F-4(a) of the
Public Health Service Act (42 U.S.C. 247d-6e(a)), as in effect on the
day before the date of enactment of this Act, are rescinded.
(c) References.--
(1) In general.--Any reference in Federal law to a section
described in subsection (a) or a provision thereof shall be
construed to be a reference to such section or provision as in
effect on the day before the date of enactment of this Act.
(2) Amendment.--Section 565(b)(1) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 360bbb-4(b)(1)) is amended by
striking ``319F-3,''.
SEC. 4. PRESERVATION OF EXISTING RIGHTS.
Nothing in this Act shall be construed to limit the ability of any
person to pursue civil remedies under Federal or State law for injury
or harm arising from the development, administration, or distribution
of any--
(1) drug or device (as such terms are defined in section
201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
321));
(2) biological product (as defined in section 351(i) of the
Public Health Service Act (42 U.S.C. 262(i))); or
(3) covered countermeasure (as defined in section 319F-3(i)
of the Public Health Service Act (42 U.S.C. 247d-6d(i)), as in
effect on the day before the date of enactment of this Act).
SEC. 5. APPLICATION.
This Act, including the repeals under section 3(a), shall only
apply with respect to actions, claims, or proceedings that--
(1) on the date of enactment of this Act, are pending
(including actions, claims, or proceedings for which a right of
appeal has not been exhausted); or
(2) are commenced on or after such date of enactment.
SEC. 6. SEVERABILITY.
If any provision of this Act or the application thereof to any
person or circumstance is held invalid, the remainder of the Act and
the application of such provision to other persons or circumstances
shall not be affected.
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