[Congressional Record Volume 155, Number 1 (Tuesday, January 6, 2009)]
[Senate]
[Page S74]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. KOHL:
  S. 75. 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; to the Committee on Finance.
  Mr. KOHL. Mr. President, I rise today to introduce the Generics First 
Act. This legislation requires the Federal Government's Medicare Part D 
prescription drug program to use generic drugs whenever available, 
unless a brand-name drug is determined to be medically necessary by a 
physician. Modeled after similar provisions in many state-administered 
Medicaid programs, this measure would reduce the high costs of the new 
prescription drug program and keep seniors from reaching the current 
coverage gap, or ``donut hole,'' by guiding beneficiaries toward cost-
saving generic drug alternatives.
  We know that the cost of prescription drugs is prohibitive, placing a 
financial strain on seniors, families, and businesses that are 
struggling to pay their health care bills. According to the National 
Bureau of Economic Research, spending on prescription drugs totaled 
$227.5 billion in 2007. People need help now and we must respond by 
expanding access to generic drugs. Generics, which on average cost 60 
percent less than their brand-name counterparts, are a big part of the 
solution to health care costs that are spiraling out of control.
  Generic drugs that are approved by the FDA must meet the same 
rigorous standards for safety and effectiveness as brand-name drugs. In 
addition to being safe and effective, the generic must have the same 
active ingredient or ingredients, be the same strength, and have the 
same labeling for the approved uses as the brand-name drug. In other 
words, generics perform the same medicinal purposes as their respective 
brand-name product.
  We know generic drugs have the potential to save seniors thousands of 
dollars and curb health spending for the Federal Government, employers, 
and families. Every year, more blockbuster drugs are coming off patent, 
setting up the potential for billions of dollars in savings. This 
legislation is just one part of a larger agenda I'm pushing to remove 
the obstacles that prevent generics from getting to market, and I urge 
my colleagues to support this legislation.
  Mr. President, I ask unanimous consent that the text of the bill be 
printed in the Record.
  There being no objection, the text of the bill was ordered to be 
printed in the Record, as follows:

                                 S. 75

       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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