Who's Waving Red Flags at FDA?

FDA’s top drug reviewer John Jenkins wants to put to rest what he says is a commonly held misperception among sponsors: You can’t always blame the Office of Surveillance & Epidemiology for putting the brakes on an application due to safety concerns.

Sometimes, Jenkins says, it’s drug reviewers in his Office of New Drugs that flag a risky product that was otherwise cleared by OSE.

Given that OSE’s primary focus in reviewing a new drug application is the product’s safety profile, it’s understandable that the office would get most of the blame for holding up a product over concerns about risk. But Jenkins says that’s too simplistic a view of the review process.

“There’s the perception in the outside world that OND is always overruling OSE in a way that may be viewed as less focused on safety,” Jenkins says. “But there are cases where the OND perspective is more conservative on the safety issue than the feedback we’re getting from our OSE colleagues.”

“I hear occasionally of situations where my staff tell me that they’re taking a more safety-focused or conservative” course “than what they think they’re getting back in the recommendation from their OSE colleagues,” Jenkins says. “It’s not...unilateral in its direction of differences of opinion….It goes both ways.”

Jenkins talked about drug safety during a wide-ranging roundtable discussion with The RPM Report. For a complete transcript of the interview—which also included OSE director Gerald Dal Pan and Office of Medical Policy director Bob Temple—click here. (If you are not already a subscriber, you can sign up for a free trial to read the story.)

Jenkins’ comments were made in the context of a new memorandum of agreement that gives FDA’s drug safety office an “equal voice” in making decisions about significant safety issues. We blogged about that here, and we’ve put together a more extensive analysis of what it all means for drug sponsors in the latest issue of The RPM Report.

FDA officials think all the attention on the perceived differences on drug safety between OND and OSE is largely overblown. Still the very public disagreements on how to handle the cardiovascular signal seen with GlaxoSmithKline’s Avandia certainly haven't dispelled the notion. “The highly publicized differences of opinion are the exception, they’re not the rule,” Jenkins says.

Perhaps not. But one thing is clear: Based on Jenkins' assessment of the drug review process, if you think that convincing drug safety officials that your products is safe is enough, you probably need to think again.