On the recordMay 23, 2012
I ask unanimous consent that reading of the amendment be dispensed with. The PRESIDING OFFICER. Without objection, it is so ordered. The amendment is as follows: (Purpose: 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) 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).…





