Benlysta Approved: FDA's Silence is Deafening
This article was originally published in RPM Report
FDA’s approval of a new lupus therapy had all the elements of a big story to put the agency in a favorable light. But FDA took a decidedly low key approach to the decision, saying it didn’t want to “overhype” the product. That may be a missed opportunity for FDA’s image with key legislators—but it underscores the sense of ambivalence FDA had towards the product all along.
You may also be interested in...
FDA faced a tough challenge with Benlysta: how to label a lupus drug that failed to show a benefit in African Americans. Here is how FDA officials explained their decision to take a very hands-off approach.
FDA would be wise to prepare for a new round of active, emotive open public sessions after the impact of the public testimony at the Benlysta lupus drug review on November 16. It’s been a long-time since a public session has had such a direct impact on creating a pro-approval atmosphere at a committee meeting.
FDA plans to "lock up" reporters before major drug safety announcements in order to brief them more thoroughly and give them access to agency experts. FDA is working on a policy paper related to its external relations efforts.