S.Amdt. 3260Senate111th Congress (2009-2011)2nd degree

S.Amdt. 3260

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.''.
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