[Congressional Record (Bound Edition), Volume 146 (2000), Part 13]
[Extensions of Remarks]
[Page 18601]
[From the U.S. Government Publishing Office, www.gpo.gov]



               HATCH-WAXMAN ACT LOOPHOLES MUST BE CLOSED

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                         HON. ALAN B. MOLLOHAN

                            of west virginia

                    in the house of representatives

                      Tuesday, September 19, 2000

  Mr. MOLLOHAN. Mr. Speaker, the modern day pharmaceutical marketplace 
was established by passage of the 1984 Drug Price Competition and 
Patent Term Restoration Act. The act, commonly known as the Hatch/
Waxman Act, gave brand companies longer patent periods to provide them 
with financial incentive to innovate. The act also gave generic drug 
companies a streamlined approval process, so they could bring less-
costly versions of drugs to market quickly after patents expired.
  The Hatch/Waxman Act worked well. Brand companies introduced hundreds 
of new drugs and grew to become the most profitable industry in the 
world. Meanwhile, generic companies were able to provide the public 
with drugs that cost significantly less.
  Unfortunately, the brand drug companies were not satisfied with their 
astounding success. They are now using loopholes in the Hatch/Waxman 
Act to file frivolous administrative and legal challenges to keep 
generic competitors out of the marketplace. For example, brand 
companies are exploiting loopholes in the act to keep generic versions 
of drugs such as Taxol for cancer and Losec for ulcers out of the 
marketplace. Each day the brand companies succeed in delaying generic 
competition, they reap windfall profits at the expense of patients.
  The Hatch/Waxman Act is a good law that will be made great when the 
loopholes are closed and fairness returns to the pharmaceutical 
marketplace.

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