No actions available.
Full Text of this Amendment
After section 17, insert the following:
SEC. 18. PROHIBITION OF AUTHORIZED GENERICS.
(a) Prohibition of Authorized Generics.--Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) is amended by adding at the end the following:
"(w) Prohibition of Authorized Generic Drugs.--
"(1) IN GENERAL.--Notwithstanding any other provision of this Act, no holder of a new drug application approved under subsection (c) shall manufacture, market, sell, or distribute an authorized generic drug, directly or indirectly, or authorize any other person to manufacture, market, sell, or distribute an authorized generic drug.
"(2) AUTHORIZED GENERIC DRUG.--For purposes of this subsection, the term `authorized generic drug'--
"(A) means any version of a listed drug (as such term is used in subsection (j)) that the holder of the new drug application approved under subsection (c) for that listed drug seeks to commence marketing, selling, or distributing, directly or indirectly, after receipt of a notice sent pursuant to subsection (j)(2)(B) with respect to that listed drug; and
"(B) does not include any drug to be marketed, sold, or distributed--
"(i) by an entity eligible for 180-day exclusivity with respect to such drug under subsection (j)(5)(B)(iv); or
"(ii) after expiration or forfeiture of any 180-day exclusivity with respect to such drug under such subsection (j)(5)(B)(iv).".
(b) Conforming Amendment.--Section 505(t)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(t)(3)) is amended by striking "In this section" and inserting "In this subsection".
(As printed in the Congressional Record for the Senate on Mar 2, 2011.)