Paul Seligman, the associate director for safety policy and communication in the FDA's Center for Drug Evaluation and Research, doesn't seem to think so. But he was careful this afternoon when explaining how the agency approached a tricky problem it was presented on May 29 - what to do with a pair of long-term studies raising questions abouta potential heart risk with two widely used AstraZeneca ulcer meds - Nexium and Prilosec. In fact, the drugmaker continued providing data through July 12, and again on July 25.
So far, the agency believes the drugs remain safe, and that doctors and patients shouldn't do anything different. The FDA actually today issued a public notice with that message, the first time the agency has attempted to communicate evolving safety issues in such an open manner. However, this is only a preliminary finding; the FDA won't complete its analysis for three months.
So in the wake of the safety controversy, most recently epitomized by Avandia, why not schedule a full-blown advisory committee meeting, and not just issue a public notice that suggests nothing has changed but could still set off a panic? Seligman acknowledged the outcome is unclear. FDA officials, however, are obviously mindful that it wouldn't look good to sit on confounding data for a year - which is what happened with Avandia (as Matthew Herper at Forbes notes).
"It's hard to know how this process will play out," Seligman told journalists on a teleconference call. "This is something of a moving target. But we were discussing at what point we should say something, and what we should say. There was a lot going on, internally, during June and July about how we should communicate...We always try to make our communications as factual and balanced as possible, and neutral in tone, to reflect what we know...Our hope is that our words speak for themselves."
By the way, the FDA's primary focus is Nexium and Prilosec, the agency is interested in data extending to the entire class of proton pump inhibitors, which would include Wyeth's Protonix and TAP's Prevacid. To read AstraZeneca's statement in response to this episode, please click here.