Amarin Takes FDA to Court Fishing for Right to Promote Off-Label Use of Vascepa | Pharmaguy's Insights Into Drug Industry News | Scoop.it
A small drug maker called Amarin has filed a lawsuit against the FDA to argue that its right to distribute information about unapproved uses of a medicine is protected by the First Amendment.


Amarin wants to be able to provide doctors with clinical trial data that does not directly pertain to the approved uses of its Vascepa prescription fish-oil pill, the lawsuit states. The FDA endorsed drug to treat people with very high levels of triglycerides, a type of fat in the blood that can lead to heart disease.


Specifically, Amarin seeks to provide doctors with data about the effectiveness of its drug to treat people with slightly lower triglyceride levels. But last month, the FDA rejected an Amarin bid to market its pill to that patient population and denied its plan to add the data to the Vascepa product labeling.


Yet the drug maker believes it has a constitutional right to distribute the information, even though such a move would be considered to be off-label promotion by the FDA. And so, Amarin is asking a federal court in New York to “declare [that] it may engage in its proposed speech about Vascepa.”


Even though doctors are free to prescribe medicines for any use, the FDA has long argued that off-label promotion may be evidence that a drug maker intended or attempted to sell misbranded medicines. The agency also maintains that off-label promotion effectively skirts the drug approval process.


One consumer advocate agrees. “If companies can go directly to physicians with studies they believe support other uses, they would be no motivation to seek FDA approval for those purposes,” says Michael Carome, the director of Public Citizen Health Research Group.


In its lawsuit, Amarin counters that FDA regulations are not only onerous, but prevent doctors from obtaining information from the “most knowledgeable sources – the drug manufacturers.” The lawsuit was joined by four physicians who, the suit says, prescribe Vascepa off-label to people with varying levels of triglycerides.