HR 4388
PREP Repeal Act
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Bill overview
This bill, the PREP Repeal Act, seeks to eliminate specific sections of the Public Health Service Act (specifically 319F-3 and 319F-4) that provide liability protection to pharmaceutical manufacturers during public health emergencies. The bill argues that these protections undermine public trust and individual rights. It rescinds funds associated with the Public Readiness and Emergency Preparedness Act (PREP Act) and clarifies that individuals can still pursue legal remedies for injuries related to pandemic products.
Key provisions
- Repeals sections 319F-3 and 319F-4 of the Public Health Service Act.
- Rescinds unobligated balances from the Covered Countermeasure Process Fund.
- Updates references to sections 319F-3 in federal law to reflect the repeal.
- Amends the Federal Food, Drug, and Cosmetic Act to remove the reference to 319F-3.
- Protects the ability of individuals to pursue civil remedies for injuries related to drugs, devices, biological products, or covered countermeasures.
- Applies the repeal only to pending or future actions related to pandemic products.
Who is affected
- Pharmaceutical manufacturers
- Individuals potentially harmed by pandemic products
- The public health system
- Federal agencies involved in public health emergencies
Notable changes
- Eliminates liability shields for pharmaceutical manufacturers during public health emergencies.
- Restores the ability for individuals to sue for harm related to pandemic products.
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119th CONGRESS — 1st Session
H. R. 4388
IN THE HOUSE OF REPRESENTATIVES
A BILL
To repeal sections 319F–3 and 319F–4 of the Public Health Service Act, and for other purposes.
This Act may be cited as the PREP Repeal Act
.
Congress finds the following:
The ability of citizens to seek redress for injury or harm is a fundamental principle of justice and due process.
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.
Section 319F–4 of the Public Health Service Act (42 U.S.C. 247d–6e).
319F–3,.
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—
drug or device (as such terms are defined in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321));
biological product (as defined in section 351(i) of the Public Health Service Act (42 U.S.C. 262(i))); or
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).
This Act, including the repeals under section 3(a), shall only apply with respect to actions, claims, or proceedings that—
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
are commenced on or after such date of enactment.
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.