An expert panel charged with recommending improvements to the U.S. drug safety system began deliberations Wednesday, even as a separate government panel faced criticism from a key lawmaker.
Instituteof Medicine(IOM) experts began a year's worth of scheduled meetings aimed at quelling safety concerns brought about in part by recent problems with the Cox-2 class of arthritis drugs such as Vioxx and Bextra.
The panel is expected to issue recommendations in July 2006. But widely varying opinions from the regulators, the drug industry, and consumer groups on how broadly the panel should apply its recommendations suggest just how difficult its deliberations may be.
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From Vioxx and Beyond
The panel of 13 economists, physicians, and legal experts was commissioned by the FDA in the wake of safety problems that eventually lead drugmakers to pull Vioxx and Bextra from the market and caused concerns about approximately 20 other anti-inflammatory painkillers.
The episode raised lingering questions about how the FDA monitors the safety of drugs years after they're approved for sales. It also highlighted complaints from some agency scientists that warnings about the safety of Cox-2 drugs and other medications were ignored at the FDA.
Several lawmakers have pointed to the problems as evidence of a need to reform the FDA. Legislation has already been introduced on Capitol Hill aimed at creating an independent safety office charged solely with monitoring the safety of already-approved drugs.
On Wednesday, one lawmaker behind the legislation criticized the FDA for a separate safety review panel formed to address drug safety concerns at the agency. In a letter to acting FDA Commissioner Lester Crawford, Sen. Charles E. Grassley (R-Iowa) questioned why 11 of the panel's 15 voting members come from the FDA division responsible for approving new drugs.
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Entire Health Care System Needs Attention
Grassley and others have argued that the division exerts undue influence over regulators charged with evaluating the safety of drugs already on the market.
They also criticized the FDA for holding the panel's first meeting -- scheduled for later this month -- behind closed doors. "It is surprising to me that the FDA has chosen to make [the] deliberations private at a time when the agency should be making every effort to improve transparency and accountability," Grassley writes.
Agency officials Wednesday urged IOM experts to broaden their scope beyond the FDA and instead extend its recommendations to the entire U.S. health care system, not just the parts policed by the agency.
Steven Galson, acting director of FDA's Center for Drug Evaluation and Research, says the panel should also look at health care technology, pharmacies, electronic prescribing, and other areas.
"I don't think you're going to be successful in making recommendations on how to improve drug safety by only focusing on the FDA," he says.
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Drug Safety Fixes
Experts are likely to address several key issues, including whether direct-to-consumer advertising of prescription drugs encourages inappropriate use by consumers and whether Congress should change the law to reform the FDA.
Bill Vaughan, senior policy analyst for Consumers Union, says the panel should act quickly to recommend reforms that Congress could make by the end of the summer. The group supports changes to the law that would give the FDA the power to order companies to strengthen warnings on safety labels instead of the current practice of negotiating those changes with companies.
The group wants IOM experts to issue an interim report detailing pressing recommendations. "We urge you to inject a sense of urgency into this process," Vaughan says.
Sheila P. Burke, the committee's co-chairwoman, says that the panel has no plans to issue early recommendations.
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Industry Recommends Narrow Approach
Meanwhile, a representative of the drug industry urged the panel to take a narrow approach and avoid recommending any strengthening of the FDA's power to regulate medications. "The FDA's current legal authorities over drug safety are robust and need not be altered," says Alan Goldhammer, associate vice president for regulatory affairs at the Pharmaceutical Research and Manufacturers of America.
John A. Gans, executive vice president of the American Pharmacists Association, told IOM experts that no single authority currently that has the power to adequately control the U.S. safety system for drugs once they are sent to pharmacy shelves.
"Your charge is comprehensive, and it is daunting. The challenge, however, is that such a system does not exist," he says.
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By Todd Zwillich, reviewed by Michael W. Smith, MD
SOURCES: Sen. Charles E. Grassley (R-Iowa). Steven Galson, acting director, center for drug evaluation and research, FDA. Bill Vaughan, senior policy analyst, Consumers Union. Alan Goldhammer, association vice president, regulatory affairs, Pharmaceutical Research and Manufacturers of America. John A. Gans, executive vice president, American Pharmacists Association.
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