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Despite law, drug safety still a concern at FDA
By Susan Heavey
Last Updated: 2010-03-10 16:37:01 -0400 (Reuters Health)
WASHINGTON (Reuters) - Recent new powers have helped the U.S. Food and Drug Administration combat contaminated medications, counterfeit pills and other safety woes, but more work is needed to address lingering concerns about drug risks, FDA officials said on Wednesday.
FDA Commissioner Margaret Hamburg told lawmakers at a U.S. House of Representatives budget panel she was "moving forward with some strategies to enhance how we address drug safety."
Hamburg declined to give details. But after the hearing, she told Reuters the changes, which the agency is "still shaping," would involve the FDA's internal work and operations and would be announced "very soon."
At a separate hearing, FDA Deputy Commissioner Dr. Joshua Sharfstein told other lawmakers the agency has made progress in overseeing an increasingly global pharmaceutical marketplace but that "there's much more to be done" to modernize the FDA.
The hearings come roughly three years after a new law broadened the FDA's authority and allowed it to require drugmakers to conduct additional clinical studies or change medication labels, among other new powers.
Drug safety has long been an issue since the FDA's inception decades ago. But the issue has risen again in recent years following high-profile scares involving Merck & Co's recalled painkiller Vioxx, Bayer's contaminated blood-thinner heparin and, most recently, concerns over GlaxoSmithKline's diabetes drug Avandia.
Democrat Henry Waxman, chair of the overall Energy & Commerce Committee, told Sharfstein drugmakers need to do more. "We need to place a greater onus on all manufacturers to oversee the safety of their own products."
Sharfstein said some companies "already do a terrific job" when it comes to monitoring the safety of their ingredients.
The 2007 law also allowed the FDA to require companies to create programs known as risk evaluation and mitigation strategies (REMS) to monitor possible side effects after approval.
While the plans aim to give the agency the authority to make sure drugmakers follow up on promises even after their drug receives approval for the U.S. market, the agency has heard from some doctors and patients who argue the plans have limited access to medications.
"It's very clearly a work in progress," Sharfstein told a House Energy and Commerce panel, adding that the FDA will hold a public meeting about the risk programs.
Republicans at the hearing also expressed concern that some of the agency's stronger powers have kept some qualified outside experts from serving on the agency's closely watched advisory panels.
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