GAO Says FDA Oversight of Off-Label Drug Promotion Is Not Systematic

摘要

The FDA takes an average of seven months from the time it begins drafting to issue regulatory letters asking drugmakers to cease violative off-label drug promotions - and companies cited for serious violations take an average of four months to act, according to a new government study. Although the agency issued 42 regulatory letters in calendar years 2003-2007 for violations of its rules for off-label promotions, it referred none to the Justice Department, which settled 11 civil and criminal actions involving such violations during that time, the Government Accountability Office (GAO) finds in its report, "FDA's Oversight of the Promotion of Drugs for Off-Label Uses." The settlements were for actions brought to Justice's attention by sources other than the FDA, the GAO says.