Analysts with healthcare equity research firm Leerink Swann say they are seeing what may be a significant increase in the number of FDA refuse-to-file (RTF) letters for drug applications. Although FDA does not report RTF letters, the analysts say they were able to identify at least eight in the last eight months, with recipients including many top-tier drug companies.
“We believe this uptick in RTFs may not be coincidental, and could potentially be related to a new review initiative for FDA to make early decisions,” the report says. “We believe FDA’s decision to file an application, approximately 60 days after the submission, is no longer a non-event and there could be a non-trivial risk associated with many filing decisions. Conversely, FDA acceptance should be considered a more meaningful positive than previously.”
The fact that some of the leading drug companies are now receiving RTFs may signal a change at FDA, according to the analysts. One possible explanation is that the agency’s new 21st Century Review initiative has lowered the threshold for RTFs. This also can reflect commissioner Margaret Hamburg’s enforcement mentality, they say.