FDA’s monitoring of postmarketing studies probed

Abstract

Pharmaceutical firms often neglect to submit required annual reports or complete information to FDA about the status of postmarketing drug safety and efficacy studies. But regulators lack the authority to punish those companies, federal investigators reported. In addition, the Department of Health and Human Services Office of Inspector General (OIG) said in a report issued on July 7, a lack of manpower and resources at FDA makes monitoring postmarketing study commitments a low priority for regulators. According to OIG, 35% of the 336 annual status reports that were or should have been submitted by drug makers in fiscal year 2004 were missing entirely or contained no information on postmarketing study commitments. About 40% of the status reports were missing one or more items of required information, investigators added. FDA reported in the March 3 Federal Register that 47% of drug companies in fiscal year 2005 had missed the deadline for submitting their annual status reports. The agency also reported that 65% of open postmarketing studies had not been started as of September 2005.