FDA Commissioner Ordered To Appear For Deposition

US Food and Drug Administration Commissioner David Kessler has been ordered to appear for a deposition scheduled in connection with the Washington Legal Foundation's First Amendment litigation against the agency. After a three-month fight among lawyers (Marketletter April 22), a US District Judge stated that the WLF "has made an adequate showing of exceptional circumstances to warrant taking the Commissioner's deposition." Dr Kessler was ordered to "appear for a deposition of up to two hours as soon as practicable."

The WLF seeks to depose Dr Kessler in connection with its suit challenging the FDA's crackdown on the dissemination of truthful information regarding off-label uses of FDA-approved drugs and medical devices. In the pending suit, the WLF argues that the FDA's restrictions violate the First Amendment rights of both providers and recipients of such information.

Kessler "Not Passive Overseer" WLF attorneys feel Dr Kessler was not just a passive overseer of the agency's crackdown but rather that at the time he became Commissioner he repeatedly said one of his top priorities was to stop manufacturers from discussing off-label uses of their products. Both before and after his confirmation, Dr Kessler has written numerous law review articles and given many speeches on his perceived need to restrict the dissemination of information about off-label uses, they note.