Source:
ReutersA senior Food and Drug Administration scientist has told congressional investigators that the FDA removed him or her from work on GlaxoSmithKline Plc's drug Avandia after voicing concerns about the safety of the diabetes pill, two senators said on Tuesday.
The unnamed FDA medical officer at one time was the primary reviewer for Avandia, according to a letter sent to the FDA by Senate Finance Committee Chairman Max Baucus, a Democrat, and Sen. Charles Grassley, the panel's top Republican.
The scientist has believed since 2005 that there was enough evidence for a strong "black box" warning on Avandia about a risk of congestive heart failure, the senators said.
In a statement titled "Senators reveal effort by the FDA to suppress scientific dissent and downplay safety concerns" released with their letter, they said the reviewer was "sidelined after voicing safety concerns" about Avandia.
Read more:
http://www.reuters.com/article/governmentFilingsNews/idUSN2421846020070725