FDA reaches settlement with company over off-label promotion
The Washington Post (3/8, Dennis) reports that the Food and Drug Administration “has decided not to appeal a federal judge’s ruling that drug maker Amarin has a First Amendment right to promote its fish-oil pill for unapproved uses, as long as the information it provides doctors is truthful and not misleading.” Amarin announced “it had settled the case with the agency,” allowing it to “continue to communicate with physicians about off-label uses for its drug, Vascepa [icosapent ethyl].”
        The AP (3/8, Perrone) reports the “closely watched case...could strengthen the drug industry’s hand in the ongoing debate over promoting drugs for uses that have not been declared safe and effective by regulators.” Although the FDA said in a statement that the settlement is “specific to this particular case and situation,” pharmaceutical experts “said companies would likely pursue more aggressive legal action against FDA, in light of the settlement.”
        The New York Times (3/8, Thomas, Subscription Publication) reports that under the terms of the settlement, “Amarin would have to submit proposed marketing materials to the agency, which could then object if it felt the information was untrue or misleading.” If Amarin and the FDA could not resolve a disagreement, “a federal judge would sort it out.”