II 109th CONGRESS 2d Session S. 4114 IN THE SENATE OF THE UNITED STATES December 8, 2006 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.

1.

Short title

This Act may be cited as the Generics First Act of 2006.

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.