FDA deal allows Amarin to promote drug for off-label use

New York

IN a deal that could change the way some companies market their drugs, the Food and Drug Administration has agreed to allow a pharmaceutical company to promote a drug for a use that the agency has not approved, the company said on Tuesday.

The agreement settles a legal case between the agency and the company, Amarin, a small drugmaker that sued the FDA last year for the right to promote its only product, Vascepa, to a broader range of patients. In August, a federal district judge in Manhattan ruled that the FDA could not prohibit Amarin from using truthful information to promote its drug, even for unapproved uses, because doing so would violate the company's right to free speech.