FDA Official Overrode Objections on Device, Senate Panel Says
Daniel Schultz, director of FDA's Center for Devices and Radiological Health, overruled unanimous recommendations of FDA scientists and administrators in approving a surgically implantable nerve stimulator for the treatment of severe depression, according to a Senate Finance Committee report released Thursday, the New York Times reports. FDA approved the device to treat severe depression last year.
The device, which is manufactured by Cyberonics, has been approved since 1997 for the treatment of epilepsy in some patients. The company began studying the device for the treatment of depression after some epilepsy patients with the device reported improved moods.
However, the device "had not proved effective against depression in its only clinical trial for the treatment of that illness," the Times reports. Cyberonics then altered the trial and submitted additional data, which some FDA staffers thought to be insufficient.
According to the committee report, scientists and lower-level administrators at FDA recommended that the agency reject Cyberonics' application seeking approval of the device for treatment of depression. An FDA advisory panel had recommended approval in a "divided" vote, but the committee report found that Schultz's order to approve the device was the only instance in the center's history in which the director "approved a device in the face of unanimous opposition from staff scientists and administrators beneath him," according to the Times.
Internal e-mail messages among FDA reviewers show that some staff members did not agree with Schultz's recommendations, the report says. In one e-mail, a reviewer wrote, "In my opinion, they do not have adequate data, and I don't understand how this can move forward." Another e-mail states, "As an M.D. interested in science, it seems to me that such an approval would be akin to approving an experimental product."
FDA spokesperson Susan Bro said the device was approved because many people with severe depression "are otherwise on their way to institutionalization because of the seriousness of their illness." Bro added that FDA officials "occasionally overrule staff recommendations after assessing all data, expert opinion and medical need."
Robert Cummins, chair and CEO of Cyberonics, said in a statement that the device is "the only safe and effective treatment option ever specifically developed, studied, FDA-approved and fully informatively labeled for the treatment of chronic or recurrent treatment-resistant depression." Cummins said FDA investigators did not interview many experts with knowledge of serious depression.
A spokesperson for Finance Committee Chair Chuck Grassley (R-Iowa), said, "The report speaks for itself," adding that Grassley had no comment. The committee for the past two years has been investigating decision-making processes at FDA, the Times notes (New York Times, 2/17).