I 
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. 
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. 
Be it enacted by the Senate and House of Representa-
tives 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 ac-
countability during public health emergencies. 
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(2) The ability of citizens to seek redress for in-
jury or harm is a fundamental principle of justice 
and due process. 
(3) The Public Readiness and Emergency Pre-
paredness Act (Public Law 109–148) (commonly re-
ferred to as the ‘‘PREP Act’’) has enabled regu-
latory capture and legal immunity for pharma-
ceutical 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(a) REPEALS.—The following sections are repealed: 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 Serv-
ice Act (42 U.S.C. 247d–6d). 
(2) Section 319F–4 of the Public Health Serv-
ice 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 re-
scinded. 
(c) REFERENCES.— 
(1) IN GENERAL.—Any reference in Federal law 
to a section described in subsection (a) or a provi-
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sion thereof shall be construed to be a reference to 
such section or provision as in effect on the day be-
fore 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 Fed-
eral or State law for injury or harm arising from the devel-
opment, administration, or distribution of any— 
(1) drug or device (as such terms are defined 
in section 201 of the Federal Food, Drug, and Cos-
metic 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 sec-
tion 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 pro-
ceedings that— 
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(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 en-
actment. 
SEC. 6. SEVERABILITY. 
If any provision of this Act or the application thereof 
to any person or circumstance is held invalid, the remain-
der of the Act and the application of such provision to 
other persons or circumstances shall not be affected. 
Æ 
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