S.Amdt. 2137
What it does: Adds SEC. 7__. PROHIBITION OF AUTHORIZED GENERICS at the end of title VII
Sen. John D. Rockefeller IV (D-WV)What it changes
1 change to S. 3187 · shown in the bill's text
Adds SEC. 7__. PROHIBITION OF AUTHORIZED GENERICS at the end of title VII
Adds a sectionIn S. 3187 · Placed on Calendar Senate
Nothing in this title (or an amendment made by this title) shall be construed in a manner inconsistent with the obligations of the United States under the Agreement Establishing the World Trade Organization, or any other treaty or international agreement to which the United States is a party.
Inserted: SEC. 7__. PROHIBITION OF AUTHORIZED GENERICS.
Inserted: (a) In General.--Section 505 (21 U.S.C. 355), as amended by section 510(a), is further amended by adding at the end the following:
Inserted: "(x) Prohibition of Authorized Generic Drugs.--
Inserted: "(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, directly or indirectly, or authorize any other person to manufacture, market, sell, or distribute an authorized generic drug.
Inserted: "(2) Authorized generic drug.--For purposes of this subsection, the term 'authorized generic drug'--
Inserted: "(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
Inserted: "(B) does not include any drug to be marketed, sold, or distributed--
Inserted: "(i) by an entity eligible for 180-day exclusivity with respect to such drug under subsection (j)(5)(B)(iv); or
Inserted: "(ii) after expiration or forfeiture of any 180-day exclusivity with respect to such drug under such subsection (j)(5)(B)(iv).".
Inserted: (b) Conforming Amendment.--Section 505(t)(3) (21 U.S.C. 355(t)(3)) is amended by striking "In this section" and inserting "In this subsection".
Original wording
At the end of title VII, add the following:
Read automatically from the Congressional Record. Check the original before relying on it.
As printed
SA 2137. Mr. ROCKEFELLER submitted an amendment intended to be proposed by him to the bill S. 3187, to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and medical devices, to establish user-fee programs for generic drugs and biosimilars, and for other purposes; which was ordered to lie on the table; as follows:
At the end of title VII, add the following:
SEC. 7__. PROHIBITION OF AUTHORIZED GENERICS.
(a) In General.--Section 505 (21 U.S.C. 355), as amended by section 510(a), is further amended by adding at the end the following:
“(x) 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, directly 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 180-day exclusivity with respect to such drug under subsection (j)(5)(B)(iv); or
“(ii) after expiration or forfeiture of any 180-day exclusivity with respect to such drug under such subsection (j)(5)(B)(iv).”.
(b) Conforming Amendment.--Section 505(t)(3) (21 U.S.C. 355(t)(3)) is amended by striking “In this section” and inserting “In this subsection”.
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Senate amendment submitted
May 22, 2012