[Congressional Record Volume 153, Number 1 (Thursday, January 4, 2007)]
[Senate]
[Pages S66-S70]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. KOHL:
  S. 28. 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 use of available generic drugs under 
the Medicare Part D prescription drug program, unless the brand name 
drug is determined to be medically necessary by a physician.
  Everywhere I go in Wisconsin, I see how prescription drug costs are a 
drain on seniors, families, and businesses that are struggling to pay 
their health care bills. They want help now and we can respond by 
expanding access to generic drugs. Generics, which on average cost 63 
percent less than their brand-name counterparts, are a big part of the 
solution to health care costs that are spiraling out of control.
  The private and public sectors, as well as individuals, are seeking 
relief from high drug costs, and Senate Special Committee on Aging has 
heard some remarkable success stories from some who have turned to 
generic drugs. Last year, General Motors testified that, in 2005, they 
spent $1.9 billion dollars on prescription drugs, 40 percent of their 
total health care spending. Their program to use generics first, when a 
generic drug is available, saves GM nearly $400 million a year.
  Last year, millions of seniors exceeded the initial $2,250 Medicare 
drug benefit and fell into the ``donut hole,'' where they had to pay 
the full price of their drugs. Using less expensive, but equally 
effective, generic drugs will keep seniors out of the ``donut hole'' 
longer and help them survive the gap in coverage.
  Generic drugs 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 drug. Generics perform the 
same as their respective brand name product.
  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 
gap in coverage or ``donut hole'' by guiding beneficiaries toward cost-
saving generic drug alternatives.
  We know generic drugs have the potential to save seniors thousands of 
dollars, and curb health spending for the Federal Government, 
employers, and families. And every year, more blockbuster drugs are 
coming off patent, setting up the potential for billions of dollars in 
savings. This legislation is one piece of a larger agenda I'm pushing 
to remove the obstacles that prevent generics from getting to market, 
and making sure that every senior, every family, every business, and 
every government program knows the value of generics and uses them to 
bring costs down. I urge my colleagues to support this legislation.
  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:

[[Page S70]]

                                 S. 28

       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.
                                 ______