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HR 3970 109th Congress House Health Administrative remedies Antibiotics Biological warfare Chemical warfare Civil actions and liability Claims Commerce Crime and Law Enforcement Department of Justice Drug approvals Drug industry Drugs Emergency Management Emergency medicine Epidemics Evidence (Law) Government liability Governmental investigations Judicial review

Bioterror and Pandemic Preparedness Protection Act

Introduced: October 6, 2005 Introduced by: Issa, Darrell Republican · California See on congress.gov
 Everywhere this bill has been 3 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Oct 17, 2005
Referred to the Subcommittee on Health, for a period to be subsequently determined by the Chairman.
Oct 6, 2005
Referred to the Committee on the Judiciary, and in addition to the Committee on Energy and Commerce, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Oct 6, 2005
Introduced in House
 Plain-English summary Congressional Research Service

Bioterror and Pandemic Preparedness Protection Act - Amends the federal judicial code 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 or donated to the National Strategic Stockpile; (2) a qualified pandemic or epidemic product that has been procured by or donated to the Secretary of Health and Human Services; or (3) a designated security countermeasure or qualified pandemic or epidemic product in an actual or potential public health emergency.

Allows a party to petition the Attorney General to investigate claims against a manufacturer, distributor, administrator, or heath care provider. Disallows judicial review of the Attorney General's decision as to whether to undertake such an investigation.

Declares that the immunity presumption shall be overcome by a determination by the Attorney General, by finding clear and convincing evidence, that the manufacturer, distributor, administrator, or health care provider intentionally or with willful disregard violated the Federal Food, Drug, and Cosmetic Act or the Public Health Service Act and that such violation: (1) caused the product to present a significant or unreasonable human health risk; and (2) proximately caused the injury alleged by the party.

What's happening now October 17, 2005

Referred to the Subcommittee on Health, for a period to be subsequently determined by the Chairman.

 Committees of jurisdiction 3