[Congressional Record Volume 144, Number 147 (Thursday, October 15, 1998)]
[Extensions of Remarks]
[Page E2199]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                      THE WAXMAN-HATCH ACT OF 1984

                                 ______
                                 

                          HON. HENRY A. WAXMAN

                             of california

                    in the house of representatives

                       Thursday, October 15, 1998

  Mr. WAXMAN. Mr. Speaker, fourteen years ago, Congress enacted the 
Drug Price Competition and Patent Term Restoration Act of 1984, better 
known as the Waxman-Hatch Act. As the Chair of the Subcommittee on 
Health and Environment, I was the law's primary sponsor in the House, 
and my friend Senator Orrin Hatch of Utah was the primary sponsor in 
the other body.
  I am very proud of the Act. Its success has truly exceeded my 
expectations. The Act balanced the interests of the brandname drug 
industry, which gained patent term extensions to restore time expended 
obtaining FDA approval, and the generic drug industry, which obtained 
clear and fair statutory standards for the timely approval of their 
products.
  As a result, generic drugs have saved American consumers and the 
Federal government billions of dollars. Today, America has a uniquely 
thriving and competitive generic drug industry. At the same time, the 
brandname drug industry has prospered like never before, posting record 
profits while tripling its research and development spending in the 
past ten years.
  One of the most significant changes under the 1984 law was the 
creation of an exemption from patent infringement for tests and other 
activities conducted for the purposes of obtaining FDA approval. The 
exemption was created to overturn the ruling in Roche versus Bolar, 
which held that uses of a patented drug to prepare a generic drug 
application to the FDA were infringing. Since its enactment, the courts 
have interpreted this exemption as applying to prescription drugs, 
biologic drugs, medical devices, as well as food and color additives.
  Recently, a number of parties have raised issues they wish the 
Congress to consider regarding the Act and its operation. Among these 
is the impact of applying the Bolar exemption to the biotechnology 
industry. This is an issue which has evoked strong views on both sides. 
Certainly, Congress should understand all of the implications for the 
industry's competitiveness, medical research, drug prices and consumer 
access. Producing breakthrough medicines and enhancing our global 
competitiveness, the biotechnology industry is of critical importance 
to American consumers. Developing these products--and making them 
available and affordable to American consumers--is crucial.
  The Congress should be fully aware of the current impact of the 
Waxman-Hatch Act. Its contributions have been significant. Examination 
of any suggested changes should be undertaken with care and a complete 
understanding of the consequences for all of the important interests 
served by the Act. After all, the reason the Act has succeeded in 
helping consumers is because it strikes a careful balance between 
promoting innovation and ensuring that consumers have timely access to 
affordable medicines.
  With the Congress due to adjourn shortly, I think it is important to 
understand fully the issues which have been raised concerning 
implementation of the Waxman-Hatch Act. I look forward to reviewing the 
positions of all interested parties. Congress must ensure that the 
Act's careful balance of interests is maintained by observing the 
Hippocratic admonition, ``First, do no harm.''

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