110th CONGRESS
1st Session
S. 28
To amend title XVIII of the Social Security Act to require the
use of generic drugs under the Medicare part D prescription drug program
when available unless the brand name drug is determined to be medically
necessary.
IN THE SENATE OF THE UNITED STATES
January 4, 2007
Mr. KOHL introduced the following bill; which was read twice and referred
to the Committee on Finance
A BILL
To amend title XVIII of the Social Security Act to require the
use of generic drugs under the Medicare part D prescription drug program
when available unless the brand name drug is determined to be medically
necessary.
Be it enacted by the Senate and House of Representatives of the United
States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the `Generics First Act of 2007'.
SEC. 2. REQUIRED USE OF GENERIC DRUGS UNDER THE MEDICARE PART D PRESCRIPTION
DRUG PROGRAM.
(a) In General- Section 1860D-2(e)(2) of the Social Security Act (42 U.S.C.
1395w-102(e)(2)) is amended by adding at the end the following new subparagraph:
`(C) NON-GENERIC DRUGS UNLESS CERTAIN REQUIREMENTS ARE MET-
`(i) IN GENERAL- Such term does not include a drug that is a nongeneric
drug unless--
`(I) no generic drug has been approved under the Federal Food, Drug,
and Cosmetic Act with respect to the drug; or
`(II) the nongeneric drug is determined to be medically necessary
by the individual prescribing the drug and prior authorization for
the drug is obtained from the Secretary.
`(ii) DEFINITIONS- In this subparagraph:
`(I) GENERIC DRUG- The term `generic drug' means a drug that is
the subject of an application approved under subsection (b)(2) or
(j) of section 505 of the Federal Food, Drug, and Cosmetic Act,
for which the Secretary has made a determination that the drug is
the therapeutic equivalent of a listed drug under section 505(j)(7)
of such Act.
`(II) NONGENERIC DRUG- The term `nongeneric drug' means a drug that
is the subject of an application approved under--
`(aa) section 505(b)(1) of the Federal Food, Drug, and Cosmetic
Act; or
`(bb) section 505(b)(2) of such Act and that has been determined
to be not therapeutically equivalent to any listed drug.'.
(b) Effective Date- The amendment made by subsection (a) shall apply to
drugs dispensed on or after the date of enactment of this Act.
END
