The FDA has long sought to ban drug manufacturers from promoting off-label uses for approved drugs. The ban – which applies only to manufacturers and their agents – is intended to safeguard the public against misbranded medicines and prevent manufacturers from effectively avoiding the drug-approval process.
In May, Amarin, a small drug manufacturer, filed a lawsuit against the FDA, arguing that the agency’s ban violates the manufacturer’s First Amendment rights. At issue in the lawsuit is the FDA’s stance on Amarin’s only product, Vascepa. In 2012, the FDA approved the drug – a prescription omega-3 fatty acid – for use in patients with “extremely high” levels of triglycerides, a type of blood disorder associated with heart disease. Recently, Amarin sought permission from the FDA to include clinical data in its product labeling that showed the drug can also lower triglycerides in those with “persistently high” levels. The FDA denied the request. Amarin contends it has a constitutional right to distribute the information, even if such a communication would be considered “off-label.” Specifically, it argues that because the information is truthful and not misleading, it is constitutionally protected speech.
This is not the first challenge to FDA’s ban on off-label communications. In 2012, the Court of Appeals for the Second Circuit overturned the conviction of a pharmaceutical sales representative for discussing off-label information with physicians. Notably, the conviction was overturned on First Amendment grounds with the court ruling that disseminating off-label information is permissible, so long as the material is truthful and not misleading. The agency never appealed the decision, limiting the case’s binding precedence to only three states – New York, Vermont, and Connecticut. Occasionally, FDA-regulated manufacturers have, similarly to Amarin, have sought to challenge the FDA’s ban in court, but these actions have settled.
According to the American Medical Association, even with the FDA’s off-label restrictions in place, off-label drug use still accounts for approximately 20 percent of all prescriptions, most of which are in the areas of rare pediatric diseases and oncology.
In the wake of the Amarin lawsuit, the FDA has announced its intention to hold a public meeting to discuss off-label drug use, addressing concerns that manufacturers’ right to free speech is being violated. According to Karen Rile, a spokesperson for the agency, the FDA would like to take stock of the wide-ranging views on this issue, while taking into account the varying issues with public health.
Although no date has been set for the FDA’s public meeting and the Amarin lawsuit is in its earliest stages, drug manufacturers should remain vigilant about future developments. Any change to the FDA’s approach to off-label discussions could greatly affect not only the bottom line, but also a manufacturer’s approach to clinical research, labeling, marketing, and regulatory relations.