The U.S. Food and Drug Administration (FDA) received another blow to its ability to regulate pharmaceutical product marketing that was dealt via a court order stating it is not in the agency’s purview to control promotional statements about certain medications’ unintended uses.
In the federal case of Amarin Pharma Inc. et al. v. Food and Drug Administration, it was ruled that officials must abide by the conclusion “that Amarin may engage in truthful and nonmisleading speech promoting the off-label use of Vascepa, i.e., to treat patients with persistently high triglycerides.”
Vascepa is basically prescription fish oil for reducing high triglycerides in adults. While the FDA cleared the drug for patients with triglyceride issues, Amarin has been touting it as the go-to pill for patients with “persistently high triglycerides,” a population for which Vascepa is not cleared.
At issue: the First Amendment. Seven months prior to the current ruling, a federal judge’s decision that Amarin has the constitutional right to make statements – given they are truthful – about Vascepa dealt the initial blow to the FDA.
According to Law360, the judge stated, “There is no basis to fear that promoting Vascepa for this off-label purpose would endanger the public health.”
Amarin had to concede somewhat in the current ruling as the company now is required to keep abreast on the engineering and science of its pill and update its promotional statements to reflect any changes. In addition, the company agreed to a process and timetable by which the FDA can question any promotional statements it deems untruthful and resolve the issue.
A clinical trial to prove Vascepa offers cardiovascular benefits, clearing it for patients with “persistently high triglycerides,” should be completed in 2018.
The lawsuit has been closely watched by the industry and is view as a seminal case when it comes to the oversight of claims by big pharma and also a landmark one involving freedom of speech.