Bioterror and Pandemic Preparedness Protection Act
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Congressional Research Service
Official summary
Version 00 · Introduced in Senate · Jul 20, 2005
Bioterror and Pandemic Preparedness Protection Act - Amends the Public Health Service Act to establish an exclusive federal cause of action for all claims relating to a qualified pandemic or epidemic product or a security countermeasure.
Restricts all causes of action for such claims against a manufacturer, distributor, or health care provider and instead provides for sole and exclusive action against the United States. Gives jurisdiction over such an action to the U.S. District Court for the District of Columbia.
Establishes a rebuttable presumption of immunity for the federal government in any such action concerning: (1) a security countermeasure that has been procured for the National Strategic Stockpile; (2) a qualified pandemic or epidemic product that has been procured by the Secretary of Health and Human Services; or (3) a security countermeasure or designated qualified pandemic or epidemic product relating to an actual or potential public health emergency.
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Allows a party to petition the Secretary to investigate claims against a manufacturer, distributor, dispenser, or heath care provider. Disallows judicial review of the Secretary's decision as to whether to undertake such an investigation.
Declares that the immunity presumption shall be overcome by a determination by the Secretary, by finding clear and convincing evidence, that the manufacturer, distributor, or health care provider intentionally or with willful disregard violated the Federal Food, Drug, and Cosmetic Act or this Act and that such violation: (1) caused the product to present a significant health risk; and (2) proximately caused the injury alleged by the petitioner.
Source last updated: Aug 15, 2025. Consult Congress.gov for the current record.
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