S.Amdt. 2952

SA 2952. Mr. Rockefeller submitted an amendment intended to be
proposed to amendment SA 2786 proposed by Mr. Reid (for himself, Mr.
Baucus, Mr. Dodd, and Mr. Harkin) to the bill H.R. 3590, to amend the
Internal Revenue Code of 1986 to modify the first-time homebuyers
credit in the case of members of the Armed Forces and certain other
Federal employees, and for other purposes; which was ordered to lie on
the table; as follows:

On page 1925, between lines 14 and 15, insert the
following:

Subtitle C--Provisions Relating to Authorized Generic Drugs

SEC. 7201. PROHIBITION OF AUTHORIZED GENERICS.

(a) In General.--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).''.
(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''.

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