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Top management at FDA is being accused of corruption by scientists in a letter. It says that managers interfered with scientists responsibilities to ensure the safety and efficacy of medical devices. According to the letter, “misconduct reaches the highest levels of CDRH management including the Center Director and Director of the ODE.”

The accusations of coercion and intimidation have led Representatives John Dingell (D-MI) and Bart Stupak (D-MI) of the House Energy and Commerce Committee to begin a congressional investigation. They believe FDA experts were “ordered, intimidated, and coerced” to modify scientific reviews, conclusions, and recommendations on devices. The scientists claim they were forced to accept data that wasn’t scientifically valid.

Bloomberg News says that the scientists reported their concerns to von Eschenbach in May. While the agency’s assistant commissioner for integrity and accountability, William McConagha, found “convincing” evidence to support the allegations, no action has been taken, according to Dingell and Stupak.

Look for more on this developing story in the Washington Wrap-Up section of MD&DI’s January issue.

Story from devicelink.com.

FDA has selected Jonathan Sackner-Bernstein, MD, chief medical officer of contract research organization Clinilabs, as CDRH’s new associate director for postmarket operations. Since Sept. 2, he has been overseeing the center’s recently created matrix structure, which comprises 13 networks each responsible for a specific product category or activity.

“Each network brings together experts from various functional areas within the center, spanning premarket review to compliance and postmarket surveillance, forming cohesive groups focusing a wide variety of expertise on identifying, analyzing, and acting on specific postmarket issues,” an agency statement said.

“Dr. Sackner-Bernstein will supervise the work of the networks by providing clear direction and priorities, fostering the development of a common vision, and clarifying roles and responsibilities. As a member of the center’s senior leadership team, he will also act as a liaison between the networks and senior center management.”

Sackner-Bernstein previously served on CDER’s Cardiovascular and Renal Drugs Advisory Panel and CDRH’s Dispute Resolution Panel.

—James G. Dickinson