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

MM&M EBOOK: PATIENT ACCESS

Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.

More in Features

Headliner: Ipsen head leads continental charge

Headliner: Ipsen head leads continental charge

"When I look at the business, I actually see patients in my mind. I don't see numbers."

Read the complete October 2014 Digital Edition

Read the complete October 2014 Digital Edition

Click the above link to access the complete Digital Edition of the October 2014 issue of MM&M, with all text, charts and pictures.

Predicting your pink slip

Predicting your pink slip

Any time a firm needs to save money, high-salaried executives are targets