Results of the second annual review of the backlog of industry post-marketing studies, a requirement under a 2007 act, show the US Food and Drug Administration (FDA) has made progress in tackling the backlog.
Of the 591 PMRs and PMCs that changed status during the second review 46 per cent were updated to fulfilled. This reflects “a significant effort from the review divisions to complete reviews of the large number of submitted final reports identified during the first backlog review”.
Furthermore, seven per cent of PMRs and PMCs that were on-schedule after the first annual review were delayed during the second. The review, performed under contract by Booz Allen Hamilton, views this as a positive performance.
Of the open PMRs and PMCs, covering new drug applications (NDA), abbreviated NDA (ANDA) and biologics license applications (BLA), between 75 and 92 per cent are on-schedule.
Most pending studies, both on- and off-schedule are in response to the Pediatric Research and Equity Act (PREA). This requires sponsors, when appropriate, to study new drugs for paediatric populations. These are generally deferred until safety information from other studies is submitted.
The review lists a number of recommended changes the FDA could implement to improve performance. For instance, to tackle off-schedule PMRs and PMCs the FDA should ensure internal processes are consistent across divisions and record milestone dates in databases.
Also, when handling final reports the FDA should only consider prioritising review efforts on documents submitted for more than 12 months after it has dealt with those with the highest impact on safety profile.
Finally, when there is no final report date and no sponsor report for more than two years Dunner letters should be issued to evaluate progress towards completion. If there is no response to the Dunner letter the FDA should make contact by phone or email.