The FDA has long prohibited companies from promoting their drugs for uses that the FDA has not approved, known as “off-label uses.” Last year, Amarin Corp. sued the FDA after the agency blocked its efforts to promote its fish oil pills for off-label uses, arguing that the firm’s claims were protected by the First Amendment. This week STAT News reported on a first-of-its-kind settlement between the FDA and Amarin, which expressly allows Amarin to promote its fish oil drug for off-label uses so long as the promotion is not false or misleading. In the article, Professor Patti Zettler explained that this agreement does not change the rules for how other companies may market their drugs, but it “might give companies some ammunition to negotiate with FDA and say they should be allowed to do the same thing.”
Patricia J. Zettler is an associate professor at Georgia State University College of Law and a member of the Center for Law, Health & Society. She was a former attorney with the Food and Drug Administration. Zettler’s research focuses on the regulation of medicine, biotechnology, and biomedical research, as well as food and drug policy.