Sec. 304. Improving program integrity

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Subchapter E of chapter V of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bbb et seq.) is amended by adding at the end the following: Notwithstanding any other provision of this Act, any period of exclusivity described in subsection

(b)granted to a person or assigned to a person on or after the date of enactment of this section with respect to a drug shall be terminated if the person to which such exclusivity was granted or any person to which such exclusivity is assigned commits a violation described in subsection (c)(1) with respect to such drug. The periods of exclusivity described in this subsection are those periods of exclusivity granted under any of the following sections: Clause (ii), (iii), or

(iv)of section 505(c)(3)(E). Clause

(iv)of section 505(j)(5)(B). Clause (ii), (iii), or

(iv)of section 505(j)(5)(F). Section 505A. Section 505E. Section 527. Section 351(k)(7) of the Public Health Service Act. Any other provision of this Act that provides for market exclusivity (or extension of market exclusivity) with respect to a drug. A violation described in this subsection is a violation of a law described in paragraph (2), enforced by a Federal or State governmental entity that results in— a criminal conviction of a person described in subsection (a); a civil judgment against a person described in subsection (a); or a settlement agreement in which a person described in subsection

(a)admits to fault. The laws described in this paragraph are the following: The provisions of this Act that prohibit— the adulteration or misbranding of a drug; the making of false statements to the Secretary or committing fraud; or the illegal marketing of a drug. Section 3729 of title 31, United States Code. Section 286 or 287 of title 18, United States Code. The Medicare and Medicaid Patient Protection and Program Act of 1987 (commonly known as the Antikickback Statute ). Section 1927 of the Social Security Act. A State law against fraud comparable to a law described in subparagraphs

(A)through (E). The date on which the exclusivity shall be terminated as described in subsection

(a)is the date on which, as applicable— a final judgment is entered relating to a violation described in subparagraph

(A)or

(B)of subsection (c)(1); or a settlement agreement described in subsection (c)(1)(C) is approved by a court order that is or becomes final and nonappealable; or if there is no court order approving a settlement agreement described in subsection (c)(1)(C), a court order dismissing the applicable case, issued after the settlement agreement, is or becomes final and nonappealable. A person described in subsection

(a)that commits a violation described in subsection (c)(1) shall report such violation to the Secretary no later than 30 days after the date that— a final judgment is entered relating to a violation described in subparagraph

(A)or

(1)shall be subject to a civil penalty in the amount of $200,000 for each day the failure to report continues, beginning with the day after the date on which such report is due as described in paragraph (1). . There are authorized to be appropriated to the Federal Trade Commission such sums as may be necessary for the purpose of carrying out activities related to addressing criminal activity and anticompetitive practices by pharmaceutical companies.

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U.S. Code

Expanded access to unapproved therapies and diagnostics
§ 360bbb

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Sec. 304

Improving program integrity

U.S.C.§ 360bbb

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