Drug & Device News

Manufacturer Goes to Court to Challenge FDA's Restrictions on Off-Label Drug Use Promotion

In a May 7 filing with the U.S. Securities and Exchange Commission (SEC), the pharmaceuticals manufacturer Amarin Pharma, Inc., a wholly-owned subsidiary of Amarin Corporation Plc, announced that it had filed suit in the U.S. District Court for the Southern District of New York seeking a declaration permitting it to share truthful and non-misleading information about its drugs with U.S. health care professionals, even if the Food and Drug Administration (FDA) considers those declarations non-permissible promotion of off-label drug use. The lawsuit claims that regulation of truthful and non-misleading information is unconstitutional under the First Amendment ' because it curtails freedom of speech ' and under the Fifth Amendment ' because the FDA's regulation is vague as applied to the company's proposed promotion of its drug, Vascepa, a prescription omega-3 fatty acid.

The FDA has approved Vascepa's promotion for treating patients with high levels of triglycerides, which can lead to heart disease. The agency turned down Amarin Pharma's proposal to market Vascepa to patients with less severe triglyceride problems, however. According to the SEC filing, Amarin Pharma contends “that broader communication of truthful information about Vascepa will improve patient care by making physicians better informed with current scientific data before deciding how to treat patients consistent with multiple national and international medical treatment guidelines. Currently, FDA regulations restricting off-label promotion limit this type of truthful and non-misleading communication, preventing most physicians from making fully-informed treatment decisions.”