A small pharmaceutical company called Amarin — based out of Dublin, Ireland –recently filed a Complaint for declaratory relief against the FDA in the United States District Court for the Southern District of New York. Amarin along with four physicians that prescribe its drug, Vascepa (omega-3 fatty acid derived from fish), allege constitutional violations of the First (freedom of speech) and Fifth (restriction against vague laws) Amendments of the United States Constitution. An Answer has not yet been filed.
The promotion of off-label drugs is the heart of this case. Amarin would like to share with potential prescribers the results of its 2011 clinical study that Vascepa lowers triglycerides, a kind of fat in the blood associated with heart disease, in patients with “persistently high” levels. However, the FDA currently only approves the drug for use in patients with extremely high levels of triglycerides.
Amarin seeks to provide the off-label information to prescribers and not the general public. Physicians, who are permitted to prescribe off-label, are already prescribing the drug in line with the clinical study and Amarin takes the position that these physicians are currently inadequately informed. Further, Amarin seeks to disclose information that is truthful and not misleading.
Opponents have said that Amarin seeks to sidestep the FDA. If drug companies were permitted to share the results of clinical studies with physicians, there would be no motivation to obtain FDA approval. The FDA has declined to comment other than to state that more comprehensive guidance is on the way. The resolution of the lawsuit as well as the FDAs anticipating guidance may have far-reaching implications for off-label promotion of drugs.