FDA refusing more new drug applications

Share this article:
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.
Share this article:
You must be a registered member of MMM to post a comment.
close

Next Article in Features

Email Newsletters

More in Features

Journal Ad Review: Reality Bites

Journal Ad Review: Reality Bites

Print's numbers may be taking some small steps in the right direction, but data is what the industry really wants to sink its teeth into. Larry Dobrow reports on what ...

Headliner: Proteus CEO takes an original path

Headliner: Proteus CEO takes an original path

Andrew Thompson, CEO, Proteus Digital Health

Leadership Exchange: How Do We Get Beyond the Pill?

Leadership Exchange: How Do We Get Beyond the ...

As its focus moves from manufacturing to service, pharma needs to partner with healthcare neophytes as well as established players. James Chase asks six experts to assess the risks and ...