H.R. 6284 — Introduced in House

I 114th CONGRESS 2d Session H. R. 6284 IN THE HOUSE OF REPRESENTATIVES September 28, 2016Mr. Smith of Washington 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. Short title This Act may be cited as the Eliminate Price Increases Act of 2016 or the EPI Act. 2. 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: (y) 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). .