FDA Focus: Suing the FDA

As many of you will already be aware, the Irish pharmaceutical company Amarin Corp (Nasdaq: AMRN) is suing the US Food and Drug Administration, writes Dr Nicola Davies in her exclusive series for The Pharma Letter.

This action is being taken over regulations prohibiting the promotion of off-label uses for its prescription omega-3 fatty acid drug, Vascepa (icosapent ethyl). Amarin is invoking the First and Fifth Amendments of the US Constitution, namely the rights to free speech and clear legislation. At first glance, this might seem like a long shot, but Amarin is presenting a strong case.

One of the biggest questions raised by this case is: Is the FDA violating the constitutional rights of pharmaceutical companies? This requires a consideration of freedom of speech and legislation.