The fight between Amarin and the FDA over what the drugmaker can say about its fish-oil pill Vascepa appears to be about free speech, but legal experts say the suit highlights a bigger issue that shows pharma’s frustration with the regulator.
"The point here is that the agency wants to be able to review communications at their discretion, on their time frame and not give any firm assurances to the companies, so what this does is creates a chilling effect," James Copland, director of the Center for Legal Policy at the Manhattan Institute, told MM&M.
The FDA approved Vascepa for patients with very high triglyceride levels in 2012. The drugmaker has further invested in clinical trials to show the drug can be effective in patients with high triglyceride levels. But in April the FDA rejected expanding the indication to include patients with high triglyceride levels because it said the company failed to show a benefit among those patients.
Amarin has said it wants to be able to speak to doctors about the drug’s benefits, including whether it can be effective in patients with high triglyceride levels. It said in its complaint that its goal is to discuss information from its clinical trials with physicians and it will not convey this off-label information to patients. Current medical practice allows physicians to prescribe drugs for purposes other than those outlined on the label; Amarin said in its complaint this is common, as did Copland and Michael Walsh, a partner at the Dallas office of Strasburger & Price.
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