In an unusual move, Amarin is taking the US Food and Drug Administration to court claiming that current regulations governing off-label promotion of medicines impede on its right to free speech.
The lawsuit, filed in the US District Court for the Southern District of New York, is seeking judicial declaration that FDA regulations limiting off-label promotion of truthful and non-misleading information “are unconstitutional under the First Amendment (freedom of speech) or Fifth Amendment (restriction against vague laws)”.
The case, brought by Amarin and four physicians, is centred on its fish oil heart drug Vascepa (icosapent ethyl). This was approved in 2012 to help reduce triglycerides levels in adult patients with severe hypertriglyceridemia, but was subsequently turned down by the FDA for reducing high levels of triglycerides in patients with heart disease who are taking statins.
The company is not seeking to actively market the drug to a wider population, but wants to be able to share with physicians data relevant information that might be considered off-label promotion, including from a clinical trial (ANCHOR) showing that Vascepa reduced triglycerides in patients with persistently high levels despite statin therapy.
The doctors involved regularly treat patients at risk of cardiovascular disease with Vascepa and, as the complaint argues, have First Amendment rights to receive truthful and non-misleading information from the drugmaker. This, they argue, would ensure that “better informed physicians make better treatment decisions for their patients”.