[Congressional Record (Bound Edition), Volume 149 (2003), Part 20]
[House]
[Page 27400]
[From the U.S. Government Publishing Office, www.gpo.gov]




                   REEXAMINING A STREAMLINED PROCESS

  (Mr. PITTS asked and was given permission to address the House for 1 
minute and to revise and extend his remarks.)
  Mr. PITTS. Mr. Speaker, our companies that develop drugs that treat 
life-threatening illnesses must go through a rigorous process to ensure 
the safety and effectiveness of their drugs. Only after these FDA 
requirements are met, can the drug be put on the market. Under rare 
circumstances, medications can be approved through an accelerated 
process known as Subpart H which was adopted to streamline the approval 
of desperately needed drugs intended to treat serious and life-
threatening illnesses.
  RU-486, an abortion drug, was approved under this streamlined 
process.
  Several weeks ago, Holly Patterson, a California teenager, died from 
an infection caused by fragments of her baby's corpse left in her 
uterus after she took RU-486 at a Planned Parenthood facility.
  Mr. Speaker, the Food and Drug Administration should not have 
authorized this dangerous drug. Legislation is being introduced today 
that takes RU-486 off the market and demands to review the process by 
which this drug was approved. I hope the House will soon consider it.

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