Date: Wed, 5 Apr 2000 14:55:50 -0700

Washington (April 5) - How could the FDA present data to outside experts about the safety and effectiveness of a company's saline - filled breast implants, while at the very same time FDA was conducting a criminal investigation of that same company for "allegations of serious irregularities in breast implant studies?" In effect, Chairman Tom Bliley (R-VA) asked FDA that question in a letter dated March 17, 2000.

After receiving FDA's response, Bliley remains concerned that adequate measures are not in place at FDA to protect American women or to uphold public confidence in the FDA approval process in these instances."The FDA has failed to present any explanation for its actions," Bliley said today in releasing FDA's response. "The agency's response is light on details, and it fails to address the questions and concerns of my initial letter. "Today, I'm left with new questions on top of old ones.

How is it that one arm of FDA can present data to outside experts about the safety and effectiveness of a company's saline - filled breast implants, while at the very same time FDA is conducting a criminal investigation of that same company for 'allegations of serious irregularities in breast implant studies?' "Why didn't the FDA have a mechanism in place to address these concerns before presenting data to the advisory panel? Are there no policies in place to protect the American public throughout this process? "The American people deserve answers to these questions, not bureaucratic double talk."