Dublin-based Amarin Pharma has sued the Food and Drug Administration (FDA for the right to talk to doctors about unapproved uses for their products, as long as they are being truthful.
Drug companies have been fined billions of dollars for talking to doctors about “off-label” uses of their medications, but they argue that they have a constitutional right to share information about a drug if they are not misleading. FDA regulations do not permit drug makers to do this. Lawyers for Amarin say this is the first time a manufacturer has pre-emptively sued the agency over free speech, before being accused of any wrongdoing, the New York Times reports.
Floyd Abrams, a First Amendment lawyer who is representing Amarin said, “If you tell the truth — if you’re not misleading — then the First Amendment protects you when you provide this sort of information.” But Dr. Michael Carome, director of health research at the advocacy group Public Citizen said, “If this lawsuit were to succeed, it would be devastating for drug safety and undermine the drug approval process.” The First Amendment has limits, Carome said, and has “always been subject to a balancing test,” according to the Times.
The lawsuit involves Amarin’s product, Vascepa, a prescription omega-3 fatty acid derived from fish. In 2012, Vascepa received FDA approval for use in patients with extremely high levels of triglycerides, a fat in the blood that has been linked to heart disease. The FDA refused to approve expanded approval, according to the Times. The company said its request was denied because, although the drug reduced triglycerides, it had not been proved to reduce the risk of heart disease. Attorneys for the company say Amarin does not intend to market Vascepa to a wider population, but merely to share with doctors the results of a 2011 company-sponsored clinical trial that showed the drug lowered triglycerides in patients with “persistently high” levels. The company also wants to make statements matching what manufacturers of fish-oil supplements are permitted to say: that “supportive but not conclusive research” shows Vascepa may reduce the risk of coronary heart disease.
While doctors are legally permitted to prescribe a drug for any use they deem appropriate, manufacturers may not promote or market a drug for anything other than an approved use. Amarin is not the first drug company to challenge the rules on free-speech grounds. In 2012, a federal appeals court threw out the conviction of a drug company sales representative who had promoted a drug for unapproved uses, saying the government had violated his freedom of speech. The three-judge panel ruled that the information shared had to be truthful and could not be misleading, according to the Times.
FDA spokeswoman Andrea Fischer said the agency is planning to issue more comprehensive guidance on what types of information can be shared, and will hold a public meeting on the topic. The agency is considering two “guidances” to industry that could permit companies to share a broader array of information about their products, such as results from clinical trials or peer-reviewed articles in medical journals, the Times reports.