[Congressional Bills 111th Congress]
[From the U.S. Government Publishing Office]
[S. 75 Introduced in Senate (IS)]







111th CONGRESS
  1st Session
                                 S. 75

 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 6, 2009

   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 2009''.

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.
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