HATCH-WAXMAN ACT LOOPHOLES MUST BE CLOSED -- HON. ALAN B. MOLLOHAN
(Extensions of Remarks - September 19, 2000)
[Page: E1529]
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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.
END