FBI investigates Summit-Visx excimer laser scandal
This article was originally published in Clinica
Executive Summary
The scandal involving US laser producers Summit Technology and Visx could prove as damaging to the FDA's reputation as the generic drug scandal of 1989. The House Commerce oversight and investigations subcommittee has held hearings on the allegation that information on Visx' system was leaked from the agency to Summit. The Federal Bureau of Investigation (FBI) is now the lead agency in the affair and if it determines that a Center for Devices & Radiological Health employee did in fact send Summit confidential Visx data, the individual concerned could face three years' imprisonment.