The Food and Drug Administration disapproved 96% ofapplications for generic drug approval in 2006, according to a reportrecently released from the Health and Human Services Office of the InspectorGeneral.
Only 1% of generics were approved and 3% were tentativelyapproved that year, says the report. The remaining 96% were found to have chemistry deficiencies upon review. Furthermore, according to the report, the rate of newapplications far outstripped the ability of the agency to process them. The FDAis required by law to review applications within 180 days, but some areas ofreview took significantly longer.
The OIG suggests that the FDA offer more guidance to drugmakers to prevent disapprovals, change their prioritization practices to reducereview times and increase the amount of applications reviewed within the 180day-deadline. Generic drugs are dispensed 88% of the time when genericsubstitutes are available under Medicare Part D, according to a 2007 OIGreport.