A decision by the U.S. Court of Appeals for the Second Circuit from last December brings to the forefront the ongoing battle between the off-label promotion and misbranding of drugs by pharmaceutical companies and the government’s efforts to curtail such marketing to protect consumers from exposure to drugs not formally evaluated by the U.S. Food and Drug Administration for a particular use.
Every new prescription drug sold to consumers in the United States carries an FDA-approved label that provides detailed instructions about the drug’s approved uses and doses. To secure FDA approval, pharmaceutical manufacturers submit data, including clinical studies, to prove the efficacy of the drug. The FDA is responsible for determining the safety and efficacy of the new drug for its intended use based on the data submitted by the pharmaceutical manufacturers. The federal Food, Drug and Cosmetic Act, which governs the interstate distribution of medical products, requires that the FDA must approve new drugs for specific uses before they are released on the market.
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