The U.S. Food and Drug Administration, responding to a lawsuit filed by Amarin Corp over information the company wants to disseminate for its fish oil drug, said it had no objection to Amarin sharing the data with healthcare providers.
The FDA’s letter to Amarin, dated June 8 and filed with a U.S. District Court judge in New York, appears to undercut the lawsuit, saying the small drugmaker should have come to the agency with its concerns “as other pharmaceutical companies sometimes do” before filing a complaint against it in court.
Amarin sells the fish oil drug Vascepa for lowering high levels of the blood fat triglycerides, which has been linked to heart disease. The company has not been allowed to claim it can reduce heart attacks and other serious heart problems when taken with cholesterol-lowering statins without proof from a large heart safety study.
However, the FDA said it had no problem with Amarin discussing information published on the drug in medical journals or data from a series of clinical trials it has already undertaken.
“FDA does not have concerns with much of the information you proposed to communicate,” said the letter to Amarin signed by Janet Woodcock, director of the agency’s Center for Drug Evaluation and Research.
“FDA would not consider the dissemination of most of that information to be false or misleading, and we do not intend to rely on it as evidence that Vascepa is intended for a use that would render Vascepa an unapproved new drug or misbranded,” the FDA letter to Amarin continued.
Under U.S. law, drug companies may only promote medicines for uses approved by the FDA, even though doctors may prescribe them in any way they see fit.
The Amarin lawsuit, which claims free speech violations, has been watched by the industry for its potential to alter rules for promoting so-called off-label uses for medicines.
Woodcock, in the letter, reminded Amarin that the FDA is planning to issue new guidelines regarding the dissemination of off-label information on medicines.
Woodcock also said Amarin would be free to make claims about the drug that the agency might view as an unapproved use if the company “were to repackage and re-label it as a dietary supplement” rather than as a prescription medicine.