US drugmaker Amarin has reached a settlement with the FDA allowing it to promote off-label use of its Vascepa (icosapent ethyl).
The drug was approved by the FDA in 2012 for treating high triglyceride levels in adults with severe hypertriglyceridaemia, but Amarin wanted to share additional efficacy data from trials not related to this indication with healthcare professionals. Amarin filed a lawsuit against the FDA in May 2015 alleging that the regulator’s restrictions limiting such off-label promotion violated the US constitution’s rights protecting free speech.
The FDA and the US government have agreed to be bound by the court's conclusion that Amarin may engage in “truthful and non-misleading speech promoting the off-label use of Vascepa”.
John Thero, president and chief executive officer of Amarin, added: “This settlement serves the public interest by supporting informed medical decisions for tens of millions of patients with persistent high triglycerides.”
Notably, the FDA has also agreed to provide Amarin with feedback for other proposed off-label promotions about the drug should it request them.
Heidi Gertner, a partner at US law firm Hogan Lovells who formerly worked for the FDA, commented: “These developments may provide additional confidence to companies considering similar communications while we await FDA’s clarification of its policy regarding communications about unapproved uses.”