When an FDA panel voted unanimously to back Eli Lilly's potential blockbuster prasugrel, questions were immediately raised on the absence of the noted cardiologist Sanjay Kaul. After first asking Kaul to come for the review, FDA staffers later called him and told him not to make the trip after Lilly objected to having him on the panel. Lilly's concerns centered on Kaul's work criticizing the drug, saying it represented intellectual bias.
Now the FDA reports that Kaul shouldn't have been excluded from the meeting and that lower-level staffers had never told upper level officials about the move to keep him off the panel. But the FDA stands by the review, saying the panel discussion was robust and Kaul's absence did not invalidate the vote.
"At every step of the way there were errors by multiple parties," said Janet Woodcock, head of the FDA's drug division, in a Wall Street Journal report.
"In my own personal opinion I didn't see anything in [Kaul's] writings ... that would preclude him from serving on the committee," said John Jenkins, the director of the FDA's Office of New Drugs. "I think he would have been a very valuable member."
- read the report from the Wall Street Journal