Allegations of Corruption Could Leave FDA in Turmoil

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.

November 19, 2008

1 Min Read
MDDI logo in a gray background | MDDI

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

Sign up for the QMED & MD+DI Daily newsletter.

You May Also Like