Bliley says FDA response on breast implants lacking
Date: Fri, 7 Apr 2000 17:05:06 -0700
From: ilena rose
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Thursday April68:01 PM ET
Congressman says FDA response on breast implants lacking
WASHINGTON, Apr 06 (Reuters Health) -- Rep. Tom Bliley (R-VA) said
Wednesday that the Food and Drug Administration (FDA) response to his inquiries about Mentor Corporation's saline breast implant approval shows that the agency is not protecting the public.
``Today, I'm left with new questions on top of old ones,'' Bliley said in a statement. ``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?'' Bliley asked.
In a letter dated March 17, Bliley asked about Mentor's March 2 appearance before an FDA advisory panel. FDA associate commissioner for legislation Melinda Plaisier wrote to Bliley, ''It is not unusual for FDA to continue the panel review process when a sponsor is a subject of an ongoing investigation.'' Plaisier said the allegations may turn out to be false, so it would not be appropriate to put a hold on the approval process during the investigation.
The FDA response left open the possibility that Mentor's implants might not be approved, despite a positive recommendation from the committee. Plaisier noted that issues outside a panel's purview, such as good manufacturing practices, could block or delay an approval.
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The FDA's response is the latest move in an ongoing flap involving Mentor, the agency, and Bliley. The brouhaha started March 23, when USA Today reported on the criminal investigation. Mentor issued a statement the same day -- as the company's shares nose-dived -- confirming an ongoing inquiry into manufacturing issues, but said it was not aware of any investigation into implant studies.
Bliley, whose House Commerce Committee has oversight of the FDA, jumped into the fray, asking the FDA to clarify. The agency confirmed the open criminal inquiry into study irregularities. While waiting for further information, Bliley on April 3 asked the
Securities and Exchange Commission (SEC) to determine if Mentor violated federal securities laws by making a public statement that was in conflict with information provided by the FDA.
Mentor still says it is unaware of a criminal investigation, and that its March 23 statement was correct. ``We absolutely, firmly believe the statements we've made are accurate,'' Mentor general counsel Douglas Altschuler told Reuters Health.
Altschuler said Mentor would soon meet with the FDA, but that the company would not issue a statement on the outcome. ''There is no need,'' Altschuler said, adding, ``it's a private matter between Mentor and the FDA. That's how the FDA wanted this to play out, that's how we wanted it to play out.''