FDA-mandated studies on prescription drugs can miss serious safety issues before and after a drug's approval, according to five current and former members of the agency's Drug Safety and Risk Management Advisory Committee, the Washington Post reports. The group, which published a critique of the agency on Monday in the Archives of Internal Medicine, includes current panel members Curt Furberg, Robyn Shapiro and Arthur Levin, and former panel members Peter Gross and Brian Strom (Lee, Washington Post, 10/10). The group recommends that Congress take the following steps to improve the agency's monitoring of drug safety:
The group also recommends the creation of a new agency -- the Center for Drug Safety -- outside of FDA's Center for Drug Evaluation and Research. The group said that FDA does not currently have authority to unilaterally pull dangerous drugs from the market, force changes to drug label warnings or penalize companies that do not adequately monitor safety. The group also contends that FDA "lacks the money and structure to insulate itself from the influence of the pharmaceutical industry," the Post reports (Washington Post, 10/10).
- Provide FDA with more direct legal authority to pursue safety violations;
- Create a "conditional" drug approval policy for certain types of drugs;
- Provide FDA with additional funding to improve safety-monitoring operations and require that it do so (Jackson, Winston-Salem Journal, 10/10);
- Mandate a broader representation of safety experts with fewer potential conflicts of interest on advisory panels; and
- Ban consumer advertising of newly approved classes of drugs until they have been on the market long enough to detect safety issues.
An abstract of the study is available online.
Furberg, a professor of public health sciences at Wake Forest University, said that under current FDA procedures, "new drugs are introduced on the market with inadequate safety documentation." Furberg said, "Serious drug reactions are later reported from the marketplace, and a large number of patients are unnecessarily injured" (Preciphs, Bloomberg/Philadelphia Inquirer, 10/10). Furberg added, "The FDA has for the past decade been aware of these problems; they've done very little to fix them."
Steven Galson, director of CDER, said, "We could improve the way that we handle drug safety by putting more people on the assessments and improving the science behind those assessments. And that is not just on FDA's shoulders - it's on the whole drug development enterprise." Galson said the recommendation for conditional approval was "intriguing." He added that the creation of a new agency was unlikely to help drug safety problems because it "would create new walls, new structures that would make it more difficult for our staff to interact with one another." Pharmaceutical Research and Manufacturers of America spokesperson Alan Goldhammer said insurers might not cover drugs that have conditional approval, thereby reducing access to new treatments. Goldhammer said, "Drugs are approved on both the benefit and the risk, and if the agency becomes too risk-averse, it runs the risk of not approving important new drugs that could benefit patients." Senate Finance Committee Chair Chuck Grassley (R-Iowa) said, "Both Congress and the administration need to take action to refocus the FDA's drug safety work and to end the agency's too-cozy relationship with the drug companies" (Washington Post, 10/10).
NPR's "All Things Considered" on Monday reported on the recommendations. The segment includes comments from Sheila Burke, chair of an Institute of Medicine committee that last month recommended changes to FDA to ensure prescription drug safety; Grassley; and Strom, a professor of biostatistics and epidemiology at the University of Pennsylvania School of Medicine (Silberner, "All Things Considered," NPR, 10/9).
The complete segment is available online in RealPlayer.
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Publication Date: 2006-10-12 16:00