WASHINGTON — Amarin Corporation has won an early victory in federal court against the Food and Drug Administration over the right to promote unapproved uses of its prescription fish-oil pill.
The preliminary ruling by a U.S. District Court judge could strengthen drugmakers' ability to distribute medical journal articles about drug uses that have not been cleared by the FDA. That issue has been contested for years by the FDA and the companies it regulates.
According to Friday's decision, Amarin has the First Amendment right to give doctors truthful information about non-approved indications of its drug Vascepa, which is used to lower a certain kind of fat.
The FDA has 60 days to appeal the ruling. A spokeswoman for the agency declined to comment on the ruling Friday morning.
Matthew Perrone, The Associated Press