H.R. 4388

119 HR 4388 IH: PREP Repeal Act
 U.S. House of Representatives
 2025-07-15
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 I  119th CONGRESS  1st Session  H. R. 4388  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    A BILL
To repeal sections 319F–3 and 319F–4 of the Public Health Service Act, and for other purposes.
1.
Short title
This Act may be cited as the   PREP Repeal Act  .
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.
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The following sections are repealed: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Public Health Service Act (42 U.S.C. 247d–6e(a)), as in effect on the day before the date of enactment of this Act, are rescinded.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, .
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).
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.
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.