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.