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Senior Citizen Politics
Hearings on Prescription Drug Safety Could Highlight
'Dissention' Among FDA Officials
Lawmakers have noted rift between the approval and
safety offices
May 31, 2007 - 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 Comments
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).
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