119-hr4388

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4388 Introduced in House

    (IH) ]

<DOC>

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 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    (a) Repeals.--The following sections are repealed: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day before the date of enactment of this Act, are rescinded.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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