FDA’s Role in Prescription Drug Labeling Unclear to Jurors

According to a recent industry newsletter, jurors often misconceive the role of the Food and Drug Administration (FDA) in approving new drugs and how pharmaceutical manufacturers create their prescription drug labels. Jurors often believe that the FDA is responsible for pharmaceutical research. In fact it is just the opposite: private drug companies produce their own studies for FDA approval. Additionally, many jurors believe that the pharmaceutical companies have sole control of warning label contents. Though the FDA has some oversight of label contents, a recent article shows that drug companies can hide information from the FDA to prevent certain risks and side effects from appearing on warning labels. Questions and misconceptions about the FDA’s role will continue with increased litigation on the FDA liability shield issue currently pending before the Supreme Court.

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