Pharmaceutical companies have long been pressuring the FDA to relax their rules regarding the promotion of approved drugs for non-approved or “off-label” uses. Currently, the FDA allows companies to give doctors data about the off-label use of a drug only if they are reported in well-controlled clinical trials published in peer-reviewed journals and reference texts. Companies are arguing that other information about their products—such as data from industry-sponsored trials or economic analyses—constitutes speech protected by the First Amendment. They argue that such information is helpful to patients and should be shared with doctors, as long as it is accurate and not misleading. In a rare legal move, Amarin Pharma has sued the FDA preemptively for the constitutional right to disseminate such information about their drug, Vascepa. Vascepa was approved by the FDA for use in patients with extremely high levels of triglycerides. Amarin would like to be allowed to promote the off-label use of Vascepa for patients with “persistently high” triglyceride levels and to present doctors with “supportive but not conclusive research” showing it may reduce the risk of coronary heart disease. Their argument may be bolstered by a 2012 case in which a federal appeals court overturned the previous conviction of a pharmaceutical salesperson for promoting off-label use of a drug. Opponents of the free speech argument do not believe that such marketing speech falls under protected speech and worry that it gives the pharmaceutical industry an inordinate ability to influence doctors’ judgments. They worry, too, that a positive ruling for the industry would undermine the FDA’s authority to protect consumers from drugs that are harmful or ineffective. While the FDA has declined to comment on the pending court case, it has scheduled a public meeting on this topic to take place this summer. The public meeting will give all parties the chance to weigh in on this controversial issue.
What do you think? Should speech that promotes off-label use of a drug be protected under the First Amendment? Or does it fall outside the definition of protected speech?