The FDA’s accelerated approvals program is on shaky ground after a series of surprise rejections, poor communication and COVID-19-focused staff.
This is according to analysis by an anonymous FDA consultant out of regulatory firm Prevision Policy, speaking to analysts at Cowen, who see the recent spate of surprising complete response letters for BioMarin, Intercept, Gilead/Galapagos and Tricida as mounting evidence that the regulator may be backing off accelerated approvals, at least outside of cancer, where speedy reviews are still the norm, and question whether complete response letters are becoming more likely.
