But before February, when the FDA cut back the product's permitted uses, its indications also included "acute bacterial sinusitis and acute exacerbation of chronic bronchitis," says the FDA. The product is now labeled with a boxed warning (indicating seriousness) about use by patients with a particular health condition, and other strengthened warnings, along with a bolded warning about possible harm to the liver that was added in 2006.
But outside of the FDA's new stance toward the drug based on safety concerns, a separate drama is playing out. Congress has been asking questions about the FDA review of the product's safety before and after its approval, and some members have accused the FDA of stifling dissent from those who raised questions about the product's safety. The FDA's announcement of the labeling changes came just before a mid-February Congressional hearing into the agency's handling of the drug.
The controversies over Ketek, and other products such as Vioxx, which was withdrawn from the market altogether after safety issues arose, are helping fuel proposals to tighten FDA drug safety oversight. It remains to be seen what if any changes in the law Congress will make to address their concerns with the FDA's actions, but it's likely some changes will be made. They could include giving the FDA more powers over drug makers to monitor safety or an independent office to keep tabs on adverse drug effects.
By Eric Greenberg Attorney-at-Law www.ericfgreenbergpc.com
But outside of the FDA's new stance toward the drug based on safety concerns, a separate drama is playing out. Congress has been asking questions about the FDA review of the product's safety before and after its approval, and some members have accused the FDA of stifling dissent from those who raised questions about the product's safety. The FDA's announcement of the labeling changes came just before a mid-February Congressional hearing into the agency's handling of the drug.
The controversies over Ketek, and other products such as Vioxx, which was withdrawn from the market altogether after safety issues arose, are helping fuel proposals to tighten FDA drug safety oversight. It remains to be seen what if any changes in the law Congress will make to address their concerns with the FDA's actions, but it's likely some changes will be made. They could include giving the FDA more powers over drug makers to monitor safety or an independent office to keep tabs on adverse drug effects.
By Eric Greenberg Attorney-at-Law www.ericfgreenbergpc.com
