enforcement action
(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 chapter or by the Federal Food, Drug, and Cosmetic Act [ 21 U.S.C. 301 et seq.], 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 [ 21 U.S.C. 355(i) , 360j(g)], 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 [ 21 U.S.C. 360bbb–3 ], or a suspension or withdrawal, based on willful misconduct, of an approval or clearance under chapter V of such Act [ 21 U.S.C. 351 et seq.] or of a licensure under section 262 of this title . (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 [ 21 U.S.C. 355(i) , 360j(g)], a debarment, an investigator disqualification, a revocation of an authorization under section 564 of such Act [ 21 U.S.C. 360bbb–3 ], or a suspension or withdrawal of an approval or clearance under chapter 5 of such Act or of a licensure under section 262 of this title ; and (II) that results from a final determination by a court or from a final agency action. (iii) Final The terms “final” and “finally”— (I) with respect to a court determination, or to a final resolution of an enforcement action that is a court determination, mean a judgment from which an appeal of right cannot be taken or a voluntary or stipulated dismissal; and (II) with respect to an agency action, or to a final resolution of an enforcement action that is an agency action, mean an order that is not subject to further review within the agency and that has not been reversed, vacated, enjoined, or otherwise nullified by a final court determination or a voluntary or stipulated dismissal. (C) Rules of construction (i) In general Nothing in this paragraph shall be construed— (I) to affect the interpretation of any provision of the Federal Food, Drug, and Cosmetic Act [ 21 U.S.C. 301 et seq.], of this chapter, or of any other applicable statute or regulation; or (II) to impair, delay, alter, or affect the authority, including the enforcement discretion, of the United States, of the Secretary, of the Attorney General, or of any other official with respect to any administrative or court proceeding under this chapter, under the Federal Food, Drug, and Cosmetic Act [ 21 U.S.C. 301 et seq.], under title 18, or under any other applicable statute or regulation. (ii) Mandatory recalls A mandatory recall called for in the declaration is not a Food and Drug Administration enforcement action.