Flap over prasugrel advisory committee leads to 2 congressional inquiries

The controversy surrounding the FDA’s cardiorenal advisory committee meeting, and in particular the “disinvitation” of Sanjay Kaul from the meeting, has prompted two separate congressional investigations. (Click here to see CardioBrief’s chronology of events.)
As reported by Susan Heavey in Reuters, Rep. Bart Stupak, the chairman of the House Energy and Commerce Subcommittee on Oversight and Investigations is writing letters of inquiry to the FDA and to Lilly.
Separately, Rep. Maurice Hinchey, a member of the House Appropriations Subcommittee on Agriculture, Rural Development, FDA, and Related Agencies, which allocates the FDA’s budget, sent a letter to the FDA’s Janet Woodcock, in which he asks:

“How can we trust the FDA if a drug maker like Eli Lilly can get a potential agency advisor that it doesn’t like disqualified from submitting an opinion?”

Click here to view Rep. Hinchey’s press release and letter to Janet Woodcock.


  1. […] A similar event occurred two and a half years ago when Sanjay Kaul was removed without explanation from the prasugrel (Efient, Lilly) advisory panel (as recounted here, here, here, and here), provoking considerable controversy and two congressional investigations. […]

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