Amarin Sues FDA over Discussion of Off-Label UsesMay 11, 2015
Amarin Pharma is suing the U.S. Food and Drug Administration (FDA) over the right to discuss off-label use of their products, claiming that they are protected by the First Amendment. Off-label use is using a drug or a medical device in a way that is not approved by the FDA. Doctors can prescribe drugs off-label, but the agency does not allow pharmaceutical companies to promote their products for unapproved uses.
Other companies have taken similar action over the issue of free-speech in the past, but Amarin's case is unusual because it has sued before being accused of any wrongdoing. The lawsuit was filed in the United States District Court in New York.
Amarin claims it should have the right to share information about off-label use with doctors so long as it is being truthful. But many are concerned that allowing this type of discussion will allow companies to endanger to patients for financial gain. It would circumvent the authority of the FDA, which is responsible for ensure a drug's safety and efficacy. Dr. Michael Carome, director of the health research group at Public Citizen, a patient safety advocacy group, said "The First Amendment right is not an absolute right. It has limits. And it's always been subject to a balancing test," according to NYT. "If this lawsuit were to succeed, it would be devastating for drug safety and undermine the drug approval process."
Amarin's actions stems from the FDA's position of the company's only product, a prescription omega-3 fatty acid drug called Vascepa. The drug was approved for patients with excessively high levels of triglycerides in 2012. The FDA denied the company's bid expand its use to wider population with severe levels. Amarin said it was denied because the drug had not been proven to lower the risk of heart disease, although a clinical trial showed a reduction in triglycerides.
The company says it only wants to share information about the clinical trial and make statements that "supportive but not conclusive research" showed that Vascepa could lower the risk of coronary heart disease. Manufacturers of fish-oil supplements already make this claim, but the FDA does not strongly regulate the supplement industry.