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