The FDA, like any agency, can make mistakes. These mistakes can cost a company millions or bankrupt it. When a mistake is made, the FDA can defend itself by saying that it had the public good in mind. Be that as it may, there should be some liability and redress if a mistake has been made as in the case of Amarin. I submit the the FDA erred. They obviously had SECOND thoughts about approving meds on biomarkers alone and without outcome studies, This is obviously within the right of the FDA. What is wrong is how they went about it with Amarin. They dictated that Amarin must start an outcomes study before the Anchor sNDA could be approved. As in the Marine indication, it was understood that biomarkers, as they been for other studies for years, were to be used in the approval process and Amarin would be doing the event study as a service. Then months afterwards they looked at studies of unrelated drugs, with no similarity in mechanisms of action to Vascepa and with serious side effects. They saw that these studies failed to show benefits( or were halted due to side effects). Then the FDA made the decision that these studies should serve as the basis for making a NEW demand on Amarin that an outcome study be completed before Anchor approval(Marine had already been approved on biomarkers alone). This is even though Vascepa has a placebo like safety like profile and both parties agreed to an SPA signed AFTER the failed or halted outcome studies of the unrelated meds were known to the FDA. I submit that this abrogation of the SPA agreement and new demand on Vascepa was not done to protect the public but to make the FDA look good. In the process, it has cast the pall of bankruptcy on Amarin. There must be some redress for the mistake the FDA has made.
