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David Mittleman
David Mittleman
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FDA Takes Action On Untested Drugs, But Is It Enough?

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Recently I have been commenting on the U.S. Food and Drug Administration (FDA) and its responsibility to protect consumers from unsafe health care products, including drugs. Last week, the FDA announced that it will remove approximately 500 untested prescription drugs from the market in an effort to enhance patient safety. The drugs are primarily for cold and flu symptoms, and involve a combination of decongestants and other medications. The 500 targeted drugs had essentially been “grandfathered” into approval, and have not been reviewed for safety or efficacy by the FDA.

Although this is a step forward for consumer protection, the actual impact of the FDA’s action will likely be minimal. The vast majority of cold and cough medications are sold over the counter (OTC) and require no prescription. These OTC drugs are safer and and more readily available than their prescription counterparts. While the FDA should be commended for taking action, we should hope to see more wide-ranging protections in the future.