Monday, January 12, 2009
More on the FDA
Public Citizen has published a short note on the letter sent by nine scientists at the Food and Drug Administration's Center for Devices and Radiological Health (CDRH) to President-elect Barack Obama and his transition team, alleging gross mismanagement at the agency. According to the letter, the FDA has "placed the American public at risk." According to the note on Public Citizen's blog, "among the charges are that scientists have been threatened and told, on occasion, to ignore FDA regulations, that FDA managers have ignored serious safety and effectiveness concerns, and that FDA experts have been excluded from product meetings because manufacturers felt that they were "biased."" You can find more on this story on CNN.com and AP. On a related story, TortsProf blog is reporting today on a New York Times article titled "F.D.A. Is Lax on Oversight During Trials, Inquiry Finds" that states that the FDA "does almost nothing to police the financial conflicts of doctors who conduct clinical trials of drugs and medical devices in human subjects, government investigators are reporting."