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.

US FDA’s workshop to discuss new ideas to assess the impact of the opioid REMS comes after the industry collaboration behind the REMS has deemed the task essentially impossible.

Whether CME for pain management has the intended impact on prescribing is likely focus of new ‘suite of studies’ intended to assess the opioid REMS program. The challenges for FDA include teasing out the impact of the risk management program amid all the other public health efforts on opioids.