Wednesday, May 11, 2005

FDA goes straight to press  USA Today opinion column by Scott Gottlieb, a fellow at the American Enterprise Institute who was director of medical policy development at the Food and Drug Administration in 2003-04 - "...The FDA made a splash, through a press release, about new labeling to warn patients about an unapproved use of these atypical antipsychotic drugs in the treatment of symptoms of dementia. The approach echoed the one the FDA took with a recent "public health advisory" about a category of popular painkillers. That warning, which covered drugs such as Aleve and Advil, sent a wave of worry across the country as patients who didn't know better wondered whether they faced an increased risk of heart attacks. The problem with both warnings is the agency's message went to the media before reaching practicing physicians. My patient's misguided fears are not unique. It is what happens when medical regulation is enforced through the press."