FDA’s Medical Device Director Calls an “All-Hands Meeting” to Discuss Approval Process

Remember when the U.S. Supreme Court decided to immunize medical device manufacturers from all liability?  Ever wonder if they knew then what they know now, they would have ruled the same way?

Just to give you a quick recap of recent events since the Court ruled…There was the letter-writing campaign led by FDA scientists (here, here), expressing concerns about “serious misconduct” surrounding the agency’s approval of dangerous medical devices.  This was followed by FDA Deputy Commissioner Frank Torti’s “shut up, or else” memo to his staff (here, here), forbidding any whistleblowing-like activities at the risk of “disciplinary sanctions and/or individual criminal liability.”  Senator Chuck Grassley (R-IA) then issued a sharp written rebuke of Torti’s actions—and Torti (perhaps coincidentally), left the agency soon after.

Now, today’s New York Times is reporting that Dr. Donna-Bea Tillman, director of the agency’s office of device evaluation, has called for an “all-hands meeting” to discuss the “strategic direction” of the device center.  According to the Times, it has been at least two years since any similar meeting has taken place.

The meeting comes on the heels of “numerous email messages” from agency scientists to principal deputy commissioner Dr. Joshua Sharfstein, as well as a memo to Sharfstein from the group, charging that the “’regulatory review process for medical devices has been severely distorted’ and that those who raised concerns about unsafe devices had been retaliated against by agency managers.”

Meanwhile, a Congressional investigation of the scientists’ concerns is underway, and the Government Accountability Office recently released a less-than-flattering report about the agency’s device center.  Congress is also considering legislation this week that would ask the Institute of Medicine to investigate the troubled division.

Of course, trouble with the FDA’s device approval process doesn’t exactly come as news to us and we’re happy to see that constructive steps seem to be underway to right the course of an agency that has been adrift for far too long.  Still, all of this underscores the important role that lawsuits play (and always have played) in supplementing the regulatory efforts of federal agencies—and more specifically, how critical it is that the Medical Device Act gets passed—soon!

Comments

[Scott Thomas]

Great article!