S.Amdt. 2403
What it does: Adds SEC. 6005. IMPROVED REGULATION OF DRUGS SOLD UNDER A NEW DRUG APPLICATION APPROVED UNDER SECTION 505C OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT on page 130, line 25
Sen. Tom Coburn (R-OK)What it changes
1 change to S. 1932
Adds SEC. 6005. IMPROVED REGULATION OF DRUGS SOLD UNDER A NEW DRUG APPLICATION APPROVED UNDER SECTION 505C OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT on page 130, line 25
Adds a sectionPrinted pageInserted: SEC. 6005. IMPROVED REGULATION OF DRUGS SOLD UNDER A NEW DRUG APPLICATION APPROVED UNDER SECTION 505C OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT.
Inserted: Section 1927 (42 U.S.C. 1396r-8) is amended--
Inserted: (1) in subsection (c)(1)(C), by adding at the end the following:
Inserted: "(iv) Notwithstanding any other provision of this section, in the case of a manufacturer that approves, allows, or otherwise permits any other drug of the manufacturer to be sold under a new drug application approved under section 505(c) of the Federal Food, Drug, and Cosmetic Act that has, as of January 1, 2006, been marketed for at least 6 months and where the product of the average manufacturer price of the manufacturer's authorized drugs and the total units of such authorized drugs, if any, during the second quarter of 2005 for which a rebate was paid under any State plan approved under this title (and which was reported as required under subsection (b)(2)(A)), does not exceed $10,000,000, the term 'best price' shall not include any price for such authorized drug available for the innovator multiple source drug of such manufacturer."; and
Inserted: (2) in subsection (k)(1)(C), as amended by section 6003(b)(2)(A), by adding at the end the following:
Inserted: "(G) Notwithstanding subparagraph (C) or any other provision of this section, in the case of a manufacturer that approves, allows, or otherwise permits any other drug of the manufacturer to be sold under a new drug application approved under section 505(c) of the Federal Food, Drug, and Cosmetic Act that has, as of January 1, 2006, been marketed for at least 6 months and where the product of the average manufacturer price of the manufacturer's authorized drugs and the total units of such authorized drugs, if any, during the second quarter of 2005 for which a rebate was paid under any State plan approved under this title (and which was reported as required under subsection (b)(2)(A)), does not exceed $10,000,000, the term 'average manufacturer price' shall not include any price paid for such authorized drug by wholesalers for drugs distributed to the retail pharmacy class of trade for the innovator multiple source drugs of such manufacturer.".
Original wording
On page 130, after line 25, insert the following:
Read automatically from the Congressional Record. Check the original before relying on it.
As printed
SA 2403. Mr. COBURN submitted an amendment intended to be proposed by him to the bill S. 1932, to provide for reconciliation pursuant to section 202(a) of the concurrent resolution on the budget for fiscal year 2006 (H. Con. Res. 95); which was ordered to lie on the table; as follows:
On page 130, after line 25, insert the following:
SEC. 6005. IMPROVED REGULATION OF DRUGS SOLD UNDER A NEW DRUG APPLICATION APPROVED UNDER SECTION 505C OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT.
Section 1927 (42 U.S.C. 1396r-8) is amended--
(1) in subsection (c)(1)(C), by adding at the end the following:
“(iv) Notwithstanding any other provision of this section, in the case of a manufacturer that approves, allows, or otherwise permits any other drug of the manufacturer to be sold under a new drug application approved under section 505(c) of the Federal Food, Drug, and Cosmetic Act that has, as of January 1, 2006, been marketed for at least 6 months and where the product of the average manufacturer price of the manufacturer's authorized drugs and the total units of such authorized drugs, if any, during the second quarter of 2005 for which a rebate was paid under any State plan approved under this title (and which was reported as required under subsection (b)(2)(A)), does not exceed $10,000,000, the term ‘best price' shall not include any price for such authorized drug available for the innovator multiple source drug of such manufacturer.”; and
(2) in subsection (k)(1)(C), as amended by section 6003(b)(2)(A), by adding at the end the following:
“(G) Notwithstanding subparagraph (C) or any other provision of this section, in the case of a manufacturer that approves, allows, or otherwise permits any other drug of the manufacturer to be sold under a new drug application approved under section 505(c) of the Federal Food, Drug, and Cosmetic Act that has, as of January 1, 2006, been marketed for at least 6 months and where the product of the average manufacturer price of the manufacturer's authorized drugs and the total units of such authorized drugs, if any, during the second quarter of 2005 for which a rebate was paid under any State plan approved under this title (and which was reported as required under subsection (b)(2)(A)), does not exceed $10,000,000, the term ‘average manufacturer price' shall not include any price paid for such authorized drug by wholesalers for drugs distributed to the retail pharmacy class of trade for the innovator multiple source drugs of such manufacturer.”.
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Senate amendment submitted
November 3, 2005