Barely a month after a big victory in a federal court over the FDA, Amarin Pharma has started off-label promotion of Vascepa, its much-disputed prescription fish-oil product, Medical Marketing & Media reports.
Vascepa was first approved by the FDA in 2012 as as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe hypertriglyceridemia (TG > 500mg/dL), a rare condition. Since then Amarin has struggled with the FDA without success to gain a much broader indication to include the 20% of the US population who have elevated triglycerides (>200 mg/dl) and existing CV disease or who are at high risk for CV disease. But the FDA has insisted that any broader indication requires the completion of REDUCE-IT, the company’s ongoing cardiovascular outcomes trial in this population.
Frustrated by the FDA’s intransigence Amarin sued the FDA and scored a sweeping victory last month. The federal judge ruled that the FDA can’t restrict Amarin’s first amendment right to disseminate off-label information about Vascepa providing that information is neither false nor misleading.
Now Amarin has started to take advantage of this ruling. On the Vascepa homepage a link “For Healthcare Professionals” leads to a PDF of a brochure containing information from the Anchor study, which Amarin claims supports the use of Vascepa in the expanded population. The first page of the brochure contains the statement that “Amarin may now disclose additional truthful, non-misleading information not included in the VASCEPA® (icosapent ethyl) Prescribing Information to healthcare professionals.”
Previous Coverage of Amarin and Vascepa:
- The Amarin Decision: Free Speech Or Truthiness?
- Secret Letter To Doctors Shows That The Amarin Lawsuit Is About Marketing, Not Free Speech
- Amarin Says It Will Complete Cardiovascular Outcomes Trial For Its Fish Oil Pill
- FDA Throws More Cold Water On Amarin’s Hopes For Vascepa
- Why The FDA Probably Won’t Approve An Expanded Indication For Amarin’s Vascepa
- FDA Advisory Panel: No Expanded Indication For Vascepa Without Outcomes Trial
- FDA Approves Vascepa, A New Fish Oil Pill From Amarin