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Could Free Speech Ruling Put Patients at Risk?

As San Diego injury attorneys, we are concerned that a recent free speech ruling could put patients at risk. The Second Circuit Court of Appeals recently overturned the criminal conviction of a pharmaceutical sales representative after finding that his First Amendment rights protected statements he made about off-label drug uses.

As we have previously discussed on this blog, prescription drugs marketed in the U.S. must have a written label or report that details its approved uses and doses, which are based on the results of clinical studies that the drug maker submitted to the FDA. The agency prohibits drug makers from marketing the drugs for unapproved uses.

However, the majority of the Second Circuit recently concluded that “the government cannot prosecute pharmaceutical manufacturers and their representatives” under the Food, Drug and Cosmetic Act for speech promoting off-label drug uses. Judge Debra Ann Livingston, the only member of the panel who dissented, said the ruling “calls into question the very foundations of our century-old system of drug regulation.”

As the Los Angeles Times reports, drug safety experts agree, arguing that the decision undermines the FDA’s authority to regulate prescription drugs. “This is a complete disgrace,” said Steven Miles, a professor of medicine and bioethics at the University of Minnesota. “What this basically does is destroy drug regulation in the United States.”

Thankfully, the Second Circuit is unlikely to get the final word. In fact, given the significance of the legal issues involved, the case could be appealed all the way to the U.S. Supreme Court.