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FDA’s new rules make it easier for drug companies to promote unapproved use of their drugs, possibly placing patients in danger

Officials from the Food and Drug Administration have finalized guidelines that make it easier for pharmaceutical companies to use medical-journal articles to promote drugs for unapproved uses. This has lead to opposition by several lawmakers, who call the rules too lenient for allowing the drug companies to distribute articles about their products to doctors, even when the articles involve uses of the drugs that haven’t been federally approved. It is illegal for pharmaceutical companies to advertise their products for uses that have not been proven to the FDA to be safe and effective. Previously, the distribution of articles promoting such use would have would have violated the Food, Drug, & Cosmetic Act (FDCA), subjecting the offending companies to FDA action or products liability lawsuits. The new rules could lead to an increase in off-label (or un-approved) prescriptions. Because it has not been proven that the drugs are not dangerous for the unapproved uses for which they will be prescribed, the patients who receive these prescriptions have an increased risk of experiencing adverse drug effects, which can cause severe injuries or death.

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