Dissent Among FDA Officials Likely at Rx Safety Hearing
A House hearing on June 6 to examine FDA's regulation of prescription drugs in the wake of recent safety concerns "may highlight the growing internal dissension between officials who approve drugs and those who track the safety" of approved drugs, the New York Times reports.
The Times notes that tension between the drug approval office and drug safety office "has long been common, but in recent months it has erupted into sniping," particularly during an advisory committee hearing last month on Merck's arthritis drug Arcoxia.
Meanwhile, "[b]ehind the scenes, agency officials were battling over Avandia," which has been shown to significantly increase the risk of heart attack, the Times reports.
Safety groups several months ago recommended that Avandia, manufactured by GlaxoSmithKline, receive a black-box label warning, but officials in FDA's drug review division opposed the label changes.
Sen. Chuck Grassley (R-Iowa) and other lawmakers have noted the rift between the approval office and safety office and have recommended that the offices split and that the safety office hold greater sway. Grassley this month introduced an amendment that would implement such a split, but it failed by one vote. However, House staff members have said that the Avandia case "breathed new life into Mr. Grassley's proposal because the House will soon debate changing the drug agency," the Times reports.
FDA Commissioner Andrew von Eschenbach in a briefing on Wednesday said the agency must work more closely with drug manufacturers, adding, "The point is that we need to look at the role of the FDA in being a bridge to the future, not a barrier to the future." Von Eschenbach said the agency also is working with others, including government agencies and independent scientists.
In addition, he defended the agency's decision on Avandia, saying that FDA intended to warn people of the risks associated with drugs when such information becomes available but that the agency must ensure people do not overreact to uncertain safety concerns (Harris, New York Times, 5/31).