-(Dow Jones)- U.S. federal regulators on Monday acknowledged it was
a mistake to “dis-invite” a leading cardiologist to a panel that was deciding
whether to recommend approval for a controversial anti-clotting drug made by
Eli
Lilly & Co.
(LLY).
Dr. Sanjay Kaul, a cardiologist at Cedars-Sinai Heart Institute in
, was scheduled to participate in a
Feb. 3
Prasugrel, an anti-clotting drug that has been linked
to dangerous internal bleeding.
Panel members at the meeting voted 9 to 0 to recommend approval of the drug.
Several days before the meeting, FDA managers received a call from
saying it had questions about Kaul’s inclusion in the meeting because he had
authored several papers that were critical of Prasugrel, FDA officials said.
representatives weren’t immediately available to comment. This news was
first reported by the blog HeartWire.
Under federal regulation, the FDA can exclude members from participating in a
meeting if they have a financial conflict of interest, such as having received
consulting fees from a company, or for “intellectual bias.” Determining
intellectual bias, or whether someone has already made their mind up about
whether a drug should be on the market, is difficult, and FDA officials say a
series of errors lead to Kaul’s exclusion from the meeting.
FDA managers that screen panel members only asked Kaul about his financial
conflicts of interest, of which he had none, not about any intellectual bias,
said Dr.
, director of the FDA’s drug division.
for the
meeting.
“At every step of the way there were errors by multiple parties,” Woodcock
said.
The FDA hasn’t done a formal review to determine whether Kaul was actually
intellectually biased, but one FDA official said he would have welcomed the
cardiologist’s input at the meeting.
“In my own personal opinion I didn’t see anything in [Kaul's] writings…that
would preclude him from serving on the committee,” said
, FDA’s
director of the Office of New Drugs. “I think he would have been a very valuable
member.”
To be sure, FDA officials described the discussion at the meeting as robust
and don’t think the kerfuffle invalidates the results of the panel.
Prasugrel isn’t on the market yet, and it’s unclear when the FDA will make a
decision about whether to approve it. The drug, co-marketed by
Daiichi Sankyo Co.
(4568.TO), is expected to bring in ample sales for
the companies.
-By Jared A. Favole, Dow Jones Newswires; 202-862-9207; jared.favole@
dowjones.com
(END) Dow Jones Newswires
02-23-09 1807ET
Copyright (c) 2009 Dow Jones & Company, Inc.