"During a recent interview with Finance Committee staff, a senior medical officer in the Office of New Drugs (OND), who at one point was the primary reviewer for Avandia, told staff investigators that s/he was told to stop participation in the review of potential cardiovascular safety problems associated with Avandia. Since 2005, the senior medical officer believed that there was enough evidence to support a black box warning regarding the risk of CHF.
Interestingly, the senior medical officer's removal from the review happened at the same time that Division of Drug Risk Evaluation (DDRE) was recommending stricter labeling for Avandia, in particular a black box warning for CHF. What makes this allegation even more troubling is that numerous FDA employees told our investigators that this senior medical officer had the most experience with the drug class that includes Avandia.
In fact, the senior medical officer had been looking at this particular drug class for about 6 years. It is our understanding that s/he was replaced by someone without experience in this drug class. The senior medical officer told our investigators, "It was the first time that this had happened to me, getting pulled off [a drug]." Another employee told our investigators, "OND does not like a black box."
For those who haven't followed AvandiaGate...
...the senators note "the recent departure of Dr. Rosemary Johann-Liang from her position in OSE was in part due to frustration with her job at the FDA. Johann-Liang had been verbally reprimanded for signing off on a recommendation that a black box label be placed on Avandia for congestive heart failure. "The agency doesn't want to hear that there are problems," she told USA Today. "I think in general, there is a culture of 'the drug is always innocent.'"
The senators add that "this new allegation is especially significant and raises our level of concern about FDA interference in safety decisions regarding Avandia and the joint Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee meeting scheduled for July 30 to discuss the safety of Avandia. We understand that OND has the lead responsibility for the upcoming advisory committee meeting instead of OSE and do not understand the logic behind this decision.
The Government Accountability Office (GAO) reported that OSE's role in advisory committee meetings was unclear and that OND generally set the agenda and determined who would present to the advisory committee and what issues would be discussed at meetings...It also has been reported to us that a majority of the advisory committee members are coming from OND consultant pools rather than OSE consultant pools. We have been advised that the FDA personnel who will be sitting at the table with the advisory committee members and participating at the meeting break down as follows: two members of OSE to represent the post-marketing perspective and four members of OND to represent the pre-approval perspectives. Given that the focus of this meeting is the safety of Avandia in the post-marketing environment, we find this troubling."