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S.Amdt. 1028Senate110th Congress (2007-2009)

S.Amdt. 1028

What it does: Inserts new text at the end of the bill
Sponsored by John D. Rockefeller IVSen. John D. Rockefeller IV (D-WV)
Submitted May 2, 2007

What it changes

1 change to S. 1082 · shown in the bill's text

Inserts text

  1. Inserts new text at the end of the bill

    Inserts

    In S. 1082 · Reported to Senate

    If any provision of this Act, an amendment made this Act, or the application of such provision or amendment to any person or circumstance is held to be unconstitutional, the remainder of this Act, the amendments made by this Act, and the application of the provisions of such to any person or circumstances shall not be affected thereby. Amend the title so as to read: "To amend the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act to reauthorize drug and device user fees and ensure the safety of medical products, and for other purposes.".

    Inserted: SEC.__. PROHIBITION OF AUTHORIZED GENERICS.

    Inserted: Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), as amended by this Act, is further amended by adding at the end the following:

    Inserted: "(s) 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, direct 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 exclusivity with respect to such drug under subsection (j)(5)(B)(iv); or

    Inserted: "(ii) after expiration or forfeiture of any exclusivity with respect to such drug under such subsection (j)(5)(B)(iv).".

    Original wording

    At the end of the bill, add the following:

Read automatically from the Congressional Record. Check the original before relying on it.

As printed

SA 1028. Mr. ROCKEFELLER (for himself, Mr. Schumer, Mr. Leahy, Mr.

Kohl, and Ms. Stabenow) submitted an amendment intended to be proposed by him to the bill S. 1082, to amend the Federal Food, Drug, and Cosmetic Act to reauthorize and amend the prescription drug user fee provisions, and for other purposes; which was ordered to lie on the table; as follows:

At the end of the bill, add the following:

SEC.__. PROHIBITION OF AUTHORIZED GENERICS.

Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), as amended by this Act, is further amended by adding at the end the following:

“(s) 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).”.

Congressional RecordPDF

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Senate amendment submitted

May 2, 2007