PUBLIC LAW 109–148—DEC. 30, 2005
119 STAT. 2823
under subsection (b), provided either the Secretary, or a State or local health authority, was provided with notice of information regarding serious physical injury or death from the administration or use of a covered countermeasure that is material to the plaintiff’s alleged loss within 7 days of the actual discovery of such information by such program planner or qualified person. ‘‘(5) EXCLUSION FOR REGULATED ACTIVITY OF MANUFACTURER OR DISTRIBUTOR.— ‘‘(A) IN GENERAL.—If an act or omission by a manufacturer or distributor with respect to a covered countermeasure, which act or omission is alleged under subsection (e)(3)(A) to constitute willful misconduct, is subject to regulation by this Act or by the Federal Food, Drug, and Cosmetic Act, such act or omission shall not constitute ‘willful misconduct’ for purposes of subsection (d) if— ‘‘(i) neither the Secretary nor the Attorney General has initiated an enforcement action with respect to such act or omission; or ‘‘(ii) such an enforcement action has been initiated and the action has been terminated or finally resolved without a covered remedy. Any action or proceeding under subsection (d) shall be stayed during the pendency of such an enforcement action. ‘‘(B) DEFINITIONS.—For purposes of this paragraph, the following terms have the following meanings: ‘‘(i) ENFORCEMENT ACTION.—The term ‘enforcement action’ means a criminal prosecution, an action seeking an injunction, a seizure action, a civil monetary proceeding based on willful misconduct, a mandatory recall of a product because voluntary recall was refused, a proceeding to compel repair or replacement of a product, a termination of an exemption under section 505(i) or 520(g) of the Federal Food, Drug, and Cosmetic Act, a debarment proceeding, an investigator disqualification proceeding where an investigator is an employee or agent of the manufacturer, a revocation, based on willful misconduct, of an authorization under section 564 of such Act, or a suspension or withdrawal, based on willful misconduct, of an approval or clearance under chapter V of such Act or of a licensure under section 351 of this Act. ‘‘(ii) COVERED REMEDY.—The term ‘covered remedy’ means an outcome— ‘‘(I) that is a criminal conviction, an injunction, or a condemnation, a civil monetary payment, a product recall, a repair or replacement of a product, a termination of an exemption under section 505(i) or 520(g) of the Federal Food, Drug, and Cosmetic Act, a debarment, an investigator disqualification, a revocation of an authorization under section 564 of such Act, or a suspension or withdrawal of an approval or clearance under chapter 5 of such Act or of a licensure under section 351 of this Act; and ‘‘(II) that results from a final determination by a court or from a final agency action.
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