Citing the First Amendment, a district judge has barred the U.S. Food and Drug Administration (FDA) from stopping Amarin, an Irish pharmaceutical company, from performing off-label promotion of its fish-oil drug.
The drug in question, “Vascepa,” has-FDA approval to be marketed for treating people with high levels of triglycerides—a form of blood fat with high levels linked to heart disease. In an attempt to expand its market, Amarin later sought approval to market Vascepa to people with lower (but still high) triglyceride levels. The FDA denied permission.
Although the FDA does not permit companies to market drugs for off-label purposes, doctors are free to prescribe them for off-label use. Amarin wanted to share the results of a 2011 study with doctors since it gave “supportive but not conclusive” research that Vascepa was effective in treating coronary heart disease in low-to-high triglyceride patients. Following a series of talks with the FDA, Amarin launched the constitutional challenge.
The lawsuit is still ongoing, but the judge’s granting of preliminary relief allows Amarin to engage in “truthful and non-misleading speech promoting the off-label use” of their drug immediately. Amarin would, however, have to tell doctors that Vascepa has not been approved to treat coronary heart disease and that its risk of death has not been assessed. Although the lawsuit and the judge’s preliminary ruling are narrowly focused, it is being closely watched for any ramifications the outcome may have concerning the FDA’s power to restrict off-label promotions for other drugs in the future.
The FDA, for its part, has warned that Amarins “frontal assault” on the drug approval framework risks bringing the country to a pre-1962 era of regulation when companies had no requirement to prove drugs to be safe or effective for the advertised use. Amarin’s own view is that the lawsuit is based on the idea that well-informed doctors can make enhanced treatment decisions.
The ruling is still preliminary and the FDA has 60 days to make an appeal.
Sources for Today’s Article:
Coyle, D., “Irish Drug Company Amarin Defeats FDA in US Lawsuit,” The Irish Times web site, August 7, 2015; http://www.irishtimes.com/business/health-pharma/irish-drug-company-amarin-defeats-fda-in-us-lawsuit-1.2310282.
Johnson, C., “FDA Barred from Restricting Company’s Promotion of Fish-oil Drug,” Washington Post web site, August 7, 2015; http://www.washingtonpost.com/news/wonkblog/wp/2015/08/07/fda-barred-from-restricting-companys-promotion-of-fish-oil-drug/.