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ARTICLE | Company News

Daiichi Sankyo, Eli Lilly cardiovascular news

March 9, 2009 7:00 AM UTC

Reps. Henry Waxman (D-Calif.) and Bart Stupak (D-Mich.) sent letters to Lilly and FDA requesting information about the removal of Dr. Sanjay Kaul from the February FDA panel meeting for Effient prasugrel from Lilly and Daiichi. In the letters, the Reps. said FDA disinvited Kaul from the panel due to an alleged "intellectual bias," after the pharma raised concerns about Kaul's research abstracts, which questioned the safety and efficacy of Effient. The lawmakers requested a briefing from FDA by March 12 to explain the agency's decision to disinvite the Cedars-Sinai Heart Institute cardiologist and voting member of FDA's Cardiovascular and Renal Drugs Advisory Committee. ...