“To repeal sections 319F-3 and 319F-4 of the Public Health Service Act, and for other purposes.”
No CRS summary available for this bill.
This section declares congressional findings that (1) liability shields under section 319F-3 of the Public Health Service Act (42 U.S.C. 247d-6d)—enacted as part of the Public Readiness and Emergency Preparedness Act (Public Law 109-148, commonly referred to as the PREP Act)—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; and (3) the PREP Act has enabled regulatory capture and legal immunity for pharmaceutical manufacturers at the expense of individual rights.
This section (1) repeals the liability immunity provisions of the Public Health Service Act for manufacturers, distributors, and administrators of covered countermeasures (e.g., vaccines, drugs, devices) during public health emergencies declared by the HHS Secretary (Sections 319F-3 and 319F-4, 42 U.S.C. 247d–6d and 247d–6e); (2) rescinds all unobligated balances in the Covered Countermeasure Process Fund; and (3) directs that any federal law references to the repealed sections be construed as they existed prior to repeal and strikes the cross-reference to Section 319F–3 from the liability protections applicable to products authorized for emergency use under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-4(b)(1)).
This section preserves 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 (1) a drug or device (as defined in section 201 of the Federal Food, Drug, and Cosmetic Act); (2) a biological product (as defined in section 351(i) of the Public Health Service Act); or (3) a covered countermeasure (as defined in section 319F–3(i) of the Public Health Service Act as in effect the day before enactment of this Act).
This section applies the Act, including the repeals under section 3(a), to actions, claims, or proceedings that are pending on the date of enactment (including those for which a right of appeal has not been exhausted) or commenced on or after such date.
This section includes a severability clause stating that if any provision of the Act or its application 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.