The Food and Drug Administration may have reached a first-of-its-kind settlement allowing Amarin to promote its prescription fish-oil pill for unapproved uses, but experts say other drug makers are unlikely to quickly engage in off-label marketing.
The settlement was reached after a federal judge last August ruled Amarin has the right to market its pill for off-label use so long as the information provided doctors is truthful and not misleading. Doctors can prescribe medicines for any purpose, which is called off-label use, but companies can only promote medicines for uses approved by the FDA.
“This is an interesting development, but I don’t think it changes how companies can market their drugs,” said Patti Zettler, a former FDA associate chief counsel who is now a Georgia State University College of Law professor. “It’s an agreement only between Amarin and the FDA. But it might give companies some ammunition to negotiate with FDA and say they should be allowed to do the same thing.”