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Full Text of this Amendment

SA 1028. Mr. ROCKEFELLER (for himself, Mr. SCHUMER, Mr. LEAHY, Mr. KOHL, and Ms. STABENOW) submitted an amendment intended to be proposed by him to the bill S. 1082, to amend the Federal Food, Drug, and Cosmetic Act to reauthorize and amend the prescription drug user fee provisions, and for other purposes; which was ordered to lie on the table; as follows:

At the end of the bill, add the following:
SEC.__. PROHIBITION OF AUTHORIZED GENERICS.
Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), as amended by this Act, is further amended by adding at the end the following:
``(s) 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, direct 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 exclusivity with respect to such drug under subsection (j)(5)(B)(iv); or
``(ii) after expiration or forfeiture of any exclusivity with respect to such drug under such subsection (j)(5)(B)(iv).''.


(As printed in the Congressional Record for the Senate on May 2, 2007.)