The Agency that Cries Wolf
This article was originally published in RPM Report
Executive Summary
FDA is being more proactive about issuing safety warnings. But, as GSK's experience with Advair shows, what looks like bad news to Wall Street may not matter as much to physicians. FDA is well aware of the limitations of its risk communication techniques, but for now the agency is commited to transparency.
You may also be interested in...
Do Black Boxes Work? US FDA Survey Would Test Impact On Prescribers
Depending on who you ask, black box warnings can fail to curb inappropriate prescribing or scare off patients who would benefit from an effective therapy. FDA is proposing a provider survey to find out what perceptions really are.
Do Black Boxes Work? US FDA Survey Would Test Impact On Prescribers
Depending on who you ask, black box warnings can fail to curb inappropriate prescribing or scare off patients who would benefit from an effective therapy. FDA is proposing a provider survey to find out what perceptions really are.
Reopening The LABA Class: FDA Shepherds Breo Through Committee For Asthma
A “safety focused” advisory committee is never something a sponsor looks forward to. But in the case of FDA’s review of GSK’s new Breo Ellipta asthma inhaler, the outcome was generally positive. In this case, FDA seems more concerned that too much emphasis on safety is steering development aware from an area of significant medical need.