I 111th CONGRESS 1st Session H. R. 573 IN THE HOUSE OF REPRESENTATIVES January 15, 2009 Mrs. Emerson (for herself, Mr. Berry, Mr. Moore of Kansas, and Mr. Wamp) introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs.

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: (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, 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). .