Politics influenced FDA's approval of a device that assists in knee-replacement surgeries, reports the New York Times. Scientific reviewers at FDA concluded that the Menafelx device, made by ReGen Biologic, was unsafe and often failed. Managers overruled that decision after pressure from New Jersey (where the device is manufactured) politicians, Senators Robert Menendez and Frank Lautenberg and Representatives Frank Pallone Jr. and Steven Rothman, all Democrats, the Times says. "The message here is that there were problems with the integrity of F.D.A.'s decision-making process that have solutions," says Joshua Sharfstein, the deputy commissioner.
Politics and Science at FDA
Sep 28, 2009