Judge Delays Amarin’s Lawsuit Against FDA Again
For the third time in four months, a federal judge has delayed drugmaker Amarin’s lawsuit against the FDA as the two sides try to negotiate a settlement.
In a court filing earlier this month, U.S. District Judge Paul Engelmayer signed off on a joint request from the two parties to delay proceedings until Feb. 17.
In a letter, attorneys for Amarin asked the judge for another extension as they try to negotiate a settlement with the FDA to end the company’s lawsuit, which accuses the agency of abridging its First Amendment rights. Specifically, the company alleges that federal promotional regulations prevent it from marketing its cholesterol drug Vascepa off-label.
The case is notable for an injunction imposed by the judge in August giving Amarin limited discretion to market Vascepa off-label until the suit is concluded.
News of this development came two days after the FDA settled another high-profile promotional speech case involving Pacira Pharmaceuticals.