[Congressional Record Volume 163, Number 127 (Thursday, July 27, 2017)]
[Senate]
[Page S4566]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

  SA 618. Mr. SANDERS submitted an amendment intended to be proposed by 
him to the bill H.R. 1628, to provide for reconciliation pursuant to 
title II of the concurrent resolution on the budget for fiscal year 
2017; which was ordered to lie on the table; as follows:

       At the appropriate place, insert the following:

     SEC. __. CONDITIONS ON AWARD OF DRUG EXCLUSIVITY.

       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:

     ``SEC. 569D. CONDITIONS ON AWARD OF DRUG EXCLUSIVITY.

       ``(a) Termination of Exclusivity.--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.
       ``(b) Exclusivities Affected.--The periods of exclusivity 
     described in this subsection are those periods of exclusivity 
     granted under any of the following sections:
       ``(1) Clause (ii), (iii), or (iv) of section 505(c)(3)(E).
       ``(2) Clause (iv) of section 505(j)(5)(B).
       ``(3) Clause (ii), (iii), or (iv) of section 505(j)(5)(F).
       ``(4) Section 505A.
       ``(5) Section 505E.
       ``(6) Section 527.
       ``(7) Section 351(k)(7) of the Public Health Service Act.
       ``(8) Any other provision of this Act that provides for 
     market exclusivity (or extension of market exclusivity) with 
     respect to a drug.
       ``(c) Violations.--
       ``(1) In general.--A violation described in this subsection 
     is a violation of a law described in paragraph (2) that 
     results in--
       ``(A) a criminal conviction of a person described in 
     subsection (a);
       ``(B) a civil judgment against a person described in 
     subsection (a); or
       ``(C) a settlement agreement in which a person described in 
     subsection (a) admits to fault.
       ``(2) Laws described.--The laws described in this paragraph 
     are the following:
       ``(A) The provisions of this Act that prohibit--
       ``(i) the adulteration or misbranding of a drug;
       ``(ii) the making of false statements to the Secretary or 
     committing fraud; or
       ``(iii) the illegal marketing of a drug.
       ``(B) The provisions of subchapter III of chapter 37 of 
     title 31, United States Code (commonly known as the `False 
     Claims Act').
       ``(C) Section 287 of title 18, United States Code.
       ``(D) The Medicare and Medicaid Patient Protection and 
     Program Act of 1987 (commonly known as the `Antikickback 
     Statute').
       ``(E) Section 1927 of the Social Security Act.
       ``(F) A State law against fraud comparable to a law 
     described in subparagraphs (A) through (E).
       ``(d) Date of Exclusivity Termination.--The date on which 
     the exclusivity shall be terminated as described in 
     subsection (a) is the date on which, as applicable--
       ``(1) a final judgment is entered relating to a violation 
     described in subparagraph (A) or (B) of subsection (c)(1); or
       ``(2)(A) a settlement agreement described in subsection 
     (c)(1)(C) is approved by a court order that is or becomes 
     final and nonappealable; or
       ``(B) 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.
       ``(e) Reporting of Information.--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--
       ``(1) a final judgment is entered relating to a violation 
     described in subparagraph (A) or (B) of subsection (c)(1); or
       ``(2)(A) a settlement agreement described in subsection 
     (c)(1)(C) is approved by a court order that is or becomes 
     final and nonappealable; or
       ``(B) 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.''.
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