[Congressional Record Volume 141, Number 157 (Wednesday, October 11, 1995)]
[Extensions of Remarks]
[Page E1917]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                               OXAPROZIN

                                 ______


                         HON. J. DENNIS HASTERT

                              of illinois

                    in the house of representatives

                      Wednesday, October 11, 1995

  Mr. HASTERT. Mr. Speaker, today I will introduce a bill to restore 
some of the rights to market the non-steroidal anti-inflammatory drug 
oxaprozin, which were lost during the 21 years it took the Food and 
Drug Administration to approve this drug--a period that consumed the 
entire 17 years of the drug's patent life. This bill is necessary in 
order to remedy the unjustifiable delay in approving this important 
drug used to treat arthritis.
  Oxaprozin, marketed by Searle under the name Daypro, was first 
patented in 1971, and an investigational new drug [IND] application was 
filed with the FDA shortly thereafter. Eleven years later, in August 
1982, a new drug application [NDA] was filed, but FDA approval was not 
granted until October 29, 1992, over 21 years after submission of the 
IND application and over 10 years after the filing of the NDA. As a 
result of this delay, the patent for oxaprozin expired before Daypro 
could be brought to market.
  While it is important that drugs meet Federal safety and efficacy 
standards, we should not lose sight of the fact that this review 
process comes at the expense of both those whose illness or suffering 
may be shortened or lessened, and at the expense of the rights of those 
to whom our laws have offered the incentives of patent protection for 
their investments. Patent protection is necessary for pharmaceutical 
manufacturers to recoup their extraordinary development costs so that 
they may obtain funds to reinvest into new and more effective products.
  The bill that I am introducing today does not grant full recovery of 
the time that was lost while oxaprozin was under review; it does not 
grant half or even a quarter of that time. This bill provides for an 
additional 2-year period of protection for oxaprozin. This 2-year 
period is based upon a thoroughly documented review of FDA inaction 
during the time the oxaprozin application was pending before the 
agency. I believe such relief is entirely fair, appropriate and 
equitable under the circumstances, and I urge my colleagues to support 
this measure.

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