Analysis: FDA Drug-Safety Measure Nixed
Posted on: Wednesday, 24 May 2006, 12:00 CDT
By TODD ZWILLICH
Republicans stripped a measure on the House floor Tuesday that would have given the Food and Drug Administration more power in ordering drug companies to perform safety trials.
The measure would have given the agency authority to force pharmaceutical manufacturers to conduct safety trials of drugs already on the U.S. market. A Government Accountability Office report concluded in March that the FDA lacks the authority to compel such trials.
Both Republican and Democratic critics of the agency have called for the additional authority as a way to guarantee closer safety tracking of drugs after they've hit the market and are being prescribed to patients.
The provision was included in a bill funding agriculture programs and the FDA by members of the House Appropriations Committee last week. But it was removed when GOP lawmakers complained that altering FDA policy was not in the committee's jurisdiction.
We just don't think that appropriators ought to be legislating in our area, Rep. Nathan Deal, R-Ga., who chairs the Energy and Commerce Subcommittee overseeing the FDA, said in an interview.
Safety trials of drugs already on the market are now done after often lengthy negotiations between drug makers and the FDA. Critics have pointed to the agency's lack of legal authority as a key factor in a rash of recent safety problems with a variety of marketed drugs, including the painkiller Vioxx and the anti-depressant Paxil.
At least one Senate bill seeks to grant the additional power to the FDA. Agency officials have said that the added authority would be helpful. Drug manufacturers have told an Institute of Medicine panel investigating FDA safety practices that no more legal authority should be granted the agency.
The measure would have given the agency the power to pull a drug from the market if its manufacturer refused to conduct a post-market trial on its safety.
Rep. Rosa DeLauro, D-Conn., who authored the provision, pointed to recent studies showing that Merck's Vioxx increased the risk of heart attacks after just four months of use -- 14 months earlier than the company had previously thought.
This alone is evidence of why postmarket studies are needed -- this authority is a critical part of the drug safety process. This authority should have become law, DeLauro said in a statement.
Deal said that his subcommittee would soon convene hearings into the FDA's safety practices. But he said he was not sure whether post-market authority would be the focus of any of the proceedings.
I feel like the issue will come up in some of those hearings, he said.
Source: United Press International
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