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.
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
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Public Health Service Act (42 U.S.C. 247d–6e(a)), as in effect on the day before the date of enactment of this Act, are rescinded.
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.
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—
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—
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.