Public Citizen: Amarin Ruling May Undermine FDA Regulatory Scheme

Public Citizen worries that a federal district court judge's ruling last week allowing Amarin Pharma Inc. to promote its triglyceride-lowering drug Vascepa off-label will undermine FDA's regulatory authority to ensure the safety and efficacy of prescription drugs. Michael Carome, director of Public Citizen's Health Research Group, said should the ruling stand it could take the United States back to the days when “snake-oil salesmen” hawked treatments that were never proven to be safe or effective. But an industry attorney, who...