S.Amdt. 3260Senate111th Congress (2009-2011)2nd degree
S.Amdt. 3260
Sponsored by
Sen. Chuck Grassley (R-IA)
Submitted December 17, 2009
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Senate amendment submitted
December 17, 2009
Text
Submitted
SA 3260. Mr. GRASSLEY 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 522, between lines 2 and 3, insert the following: SEC. 2603. PAYMENT FOR ILLEGAL UNAPPROVED DRUGS. (a) Findings.--Congress finds that each year, the Medicaid program under title XIX of the Social Security Act (42 U.S.C. 1396 et seq.) pays millions of dollars in reimbursement for covered outpatient drugs that are not approved by the Food and Drug Administration under a new drug application under section 505(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)) or an abbreviated new drug application under section 505(j) of such Act, or that such drug is not subject such section 505 or section 512 due to the application of section 201(p) of such Act (21 U.S.C. 321(p)). (b) Listing of Drugs and Devices.--Section 510 of the Food, Drug and Cosmetic Act (21 U.S.C. 360) is amended-- (1) in subsection (j)(1)(B)-- (A) in clause (i), by inserting ``in the case of a drug, the authority under this Act that does not require such drug to be subject to section 505 and section 512,'' after ``labeling for such drug or device,''; and (B) in clause (ii), by inserting ``, in the case of a drug, the authority under this Act that does not require such drug to be subject to section 505 and section 512,'' after ``for such drug or device''; and (2) in subsection (f)-- (A) by striking ``(f) The Secretary'' and inserting the following: ``(f) Inspection by Public of Registration.-- ``(1) In general.--The Secretary''; and (B) by adding at the end the following: ``(2) List of drugs that are not approved under section 505 or 512.--Not later than January 1, 2011, the Secretary shall make available to the public on the Internet website of the Food and Drug Administration a list that includes, for each drug described in subsection (j)(1)(B)-- ``(A) the drug; ``(B) the person who listed such drug; and ``(C) the authority under this Act that does not require such drug to be subject to section 505 and section 512, as provided by such person in such list.''. (c) Payment for Covered Outpatient Drugs.--Section 1927 of the Social Security Act (42 U.S.C. 1396r-8) is amended by inserting at the end the following: ``(l) Condition.--Beginning January 1, 2011, no State shall make any payment under this section for any covered outpatient drug unless such State first verifies with the Food and Drug Administration that such covered outpatient drug has been approved by the Food and Drug Administration under a new drug application under section 505(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)) or an abbreviated new drug application under section 505(j) of such Act, or that such drug is not subject such section 505 or section 512 due to the application of section 201(p) of such Act (21 U.S.C. 321(p)). The Secretary shall have the authority to proscribe regulations to create an information sharing protocol to allow States to verify that a covered outpatient drug has been approved by the Food and Drug Administration.''. ______