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www.fdanews.com/articles/61354-enzi-closes-investigation-into-fda-approval-process-for-silicone-breast-implants

ENZI CLOSES INVESTIGATION INTO FDA APPROVAL PROCESS FOR SILICONE BREAST IMPLANTS

August 1, 2006

Sen. Mike Enzi (R-Wyo.), chairman of the Health, Education, Labor and Pensions Committee, announced July 28 he has closed a yearlong investigation into the FDA's advisory committee review of silicone breast implants.

The investigation was prompted by dozens of groups and individuals alleging impropriety in the agency's approval process. Five advocacy groups, including the National Organization for Women, the National Women's Health Network and the National Research Center for Women & Families, sent a letter Dec. 13, 2005, to the committee urging an investigation into the FDA's plan to lift silicon implant restrictions.

The investigation identified some concerns but "found no irregularities in the process that require a reversal of FDA action following the recommendations of the 2005 panel," Enzi said in a recently released committee report.

"We will build on the findings of this investigation by including provisions to address the problem of potential conflicts of interest among advisory committee members in the drug safety bill Sen. Edward Kennedy (D-Mass.) and I are preparing for introduction," Enzi said.