[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[S. 3695 Introduced in Senate (IS)]








109th CONGRESS
  2d Session
                                S. 3695

   To amend the Federal Food, Drug, and Cosmetic Act to prohibit the 
                 marketing of authorized generic drugs.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             July 19, 2006

 Mr. Rockefeller (for himself, Mr. Schumer, and Mr. Leahy) introduced 
the following bill; which was read twice and referred to the Committee 
               on Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
   To amend the Federal Food, Drug, and Cosmetic Act to prohibit the 
                 marketing of authorized generic drugs.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. 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:
    ``(o) 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).''.
                                 <all>