To revoke the exclusivity of certain entities that are responsible for violations of the Federal Food, Drug, and Cosmetic Act, the False Claims Act, and other certain laws.
Sen. Bernard Sanders (I-VT)Legislative Activity
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Senate amendment not agreed to: Amendment SA 2109, under the order of 5/23/12, not having achieved 60 votes in the affirmative, was not agreed to in Senate by Yea-Nay Vote. 9 - 88. Record Vote Number: 109.
May 24, 2012
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Senate amendment not agreed to: Amendment SA 2109, under the order of 5/23/12, not having achieved 60 votes in the affirmative, was not agreed to in Senate by Yea-Nay Vote. 9 - 88. Record Vote Number: 109.
May 24, 2012
Roll call votes on amendments in Senate: Amendment SA 2109, under the order of 5/23/12, not having achieved 60 votes in the affirmative, was not agreed to in Senate by Yea-Nay Vote. 9 - 88. Record Vote Number: 109.
May 24, 2012
Considered by Senate. (consideration: CR S3536, S3540-3541, S3543, S3562-3563)
May 24, 2012
Amendment SA 2109, under the order of 5/23/12, not having achieved 60 votes in the affirmative, was not agreed to in Senate by Yea-Nay Vote. 9 - 88. Record Vote Number: 109.
May 24, 2012
Senate amendment proposed (on the floor): Amendment SA 2109 proposed by Senator Sanders.(consideration: CR S3485-3488; text: CR S3485-3486)
May 23, 2012
Amendment SA 2109 proposed by Senator Sanders. (consideration: CR S3485-3488; text: CR S3485-3486) To revoke the exclusivity of certain entities that are responsible for violations of the Federal Food, Drug, and Cosmetic Act, the False Claims Act, and other certain laws.
May 23, 2012
Senate amendment submitted
May 17, 2012
Votes
1 roll call on this amendment
Text
Submitted
SA 2109. Mr. SANDERS submitted an amendment intended to be proposed by him to the bill S. 3187, to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and medical devices, to establish user-fee programs for generic drugs and biosimilars, and for other purposes; which was ordered to lie on the table; as follows: At the end of title XI, add the following: SEC. 11__. CONDITIONS ON AWARD OF DRUG EXCLUSIVITY. Subchapter E of chapter V (21 U.S.C. 360bbb et seq.) is amended by inserting after section 569C, as added by this Act, 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-- ``(1) commits a violation described in subsection (c)(1) with respect to such drug; or ``(2) fails to report such a violation as required by subsection (e). ``(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.''. ______