Is device chief's exit a sign of tougher FDA?

The head of FDA's embattled devices division is stepping down. After a series of scandals that revealed a science-versus-industry culture at the Center for Devices and Radiological Health, Daniel Schultz said that his "stepping down at this time would be in the best interest of the center and the agency."

The independence of the device division has been debated for years, at least since Sen. Charles Grassley questioned the approval of a nerve-stimulation gadget to treat depression, the Wall Street Journal reports. But internal dissent hit the news in a big way last fall, when scientists complained that top brass had OK'd devices in spite of staff's safety and efficacy concerns--and that some scientists who balked faced retaliation.

Then a GAO investigation found [1] that less than one-tenth of the devices approved from 2003 to 2007 were subject to rigorous testing. And the scientists appealed [2] to the new president for change, saying that they'd complained to lawmakers before--and were slapped down by agency management.

Regardless of the truth of these claims, analysts said that Schultz's departure could be part of Commissioner Margaret Hamburg's push to toughen up FDA standards and enforcement. "[T]hey've been embarrassed," Morningstar analyst Debbie Wang told Reuters. "[W]hether there's truth behind it or not, there certainly is the perception that some things happened on his watch that were negative. ... You're going to have to reach a higher bar [now] in order to get approval."

- read the WSJ story [3]
- check out the coverage [4] from Reuters

Related Articles:
GAO: FDA's device review too slack [1]
FDA scientists plea for agency reform [2]
Sweep the FDA clean, Stupak says [5]
Kindler: Take politics out of the FDA [6]
GAO asked to probe FDA on discipline [7]