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Amarin sues FDA over off-label policy

Claims block on discussing off-label uses conflicts freedom of speech

amarin logoIrish pharma company Amarin Corp is suing the FDA, claiming that a block on discussing off-label uses for drugs contravenes the US laws on freedom of speech.

The lawsuit relates to the company's Vascepa (icosapent ethyl), an omega-3 fatty acid product that is used to reduce elevated levels of triglycerides in the blood. Vascepa has a narrow indication as it is only indicated by the FDA for use in patients with severely raised triglycerides, above 500mg/dl.

Along with four physicians, Amarin is trying to convince the FDA to allow it to discuss unapproved uses for Vascepa with doctors, and specifically to talk about the benefits of reducing triglycerides in terms of reducing the risk of cardiovascular diseases such as heart attack and stroke.

Under US law, doctors are free to prescribe medicines as they see fit, but companies are prohibited from promoting any use beyond the FDA-approved label for a drug and can be liable to hefty fines if they are deemed to have done so. 

While the FDA has been challenged legally over its off-label policy in the past, this is thought to be the first time that a company has tried to assert its First Amendment rights without first having been reprimanded by the agency for overstepping the mark.

Amarin's legal representative in the case - Floyd Abrams of Cahill Gordon & Reindel - argues that Amarin should be able to talk to doctors about the evidence that reducing triglycerides may reduce the risk of heart disease, even though Vascepa itself has not yet been shown to achieve that objective in trials.

Vascepa is Amarin's only approved drug and was cleared by the FDA in 2012, although efforts by the company to expand its use in patients with lower triglyceride levels proved unsuccessful. In 2013, the FDA asked for more data to support its benefits in that setting. 

Amarin is in the process of carrying out a cardiovascular outcomes study called REDUCE-IT to try to support its position, with results due in 2017. In the meantime Vascepa is bringing in modest sales, with first-quarter turnover of around $15m, albeit up from $11m a year ago.

"We filed a lawsuit in federal court … to permit Amarin to share truthful and non-misleading information with healthcare professionals in the US that would be considered off-label by the FDA," said the company's chief executive John Thero late last week.

"It's important to highlight that a lawsuit does not seek to offend FDA's regulatory structure and the judgment requested would not," he added.

Amarin wants to be able to communicate the results of another study called ANCHOR to doctors, which it believes would allow it make a "qualified health claim" for the drug - in other words alluding to the benefits of triglyceride reduction but stating that the effect of Vascepa on cardiovascular risk has not been determined and that FDA has not approved it for cardiovascular risk reduction.

Critics of the move include advocacy organisation Public Citizen, which warned that the case sidesteps the normal drug approval process and undermines the FDA and makes it less likely that companies will generate hard data to support other uses. 

Article by
Phil Taylor

11th May 2015

From: Regulatory



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