he Food and Drug Administration may have reached a first-of-its-kind settlement allowing Amarin to promote its prescription fish-oil pill for unapproved uses, but experts say other drug makers are unlikely to quickly engage in off-label marketing.
The settlement was reached after a federal judge last August ruled Amarin has the right to market its pill for off-label use so long as the information provided doctors is truthful and not misleading. Doctors can prescribe medicines for any purpose, which is called off-label use, but companies can only promote medicines for uses approved by the FDA.
“This is an interesting development, but I don’t think it changes how companies can market their drugs,” said Patti Zettler, a former FDA associate chief counsel who is now a Georgia State University College of Law professor. “It’s an agreement only between Amarin and the FDA. But it might give companies some ammunition to negotiate with FDA and say they should be allowed to do the same thing.”
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The case had been closely watched for its potential to determine whether the FDA can prohibit drug makers from distributing off-label information. The issue has been widely debated after a federal appeals court in 2012 overturned a criminal conviction of a sales rep for promoting off-label uses. The court ruled his speech was protected, since the information was truthful and not misleading.
In this instance, Amarin sought to provide doctors with clinical trial data that does not directly pertain to the approved uses of its Vascepa fish-oil pill. The FDA endorsed the drug four years ago to treat people with very high levels of triglycerides, a type of fat in the blood that can lead to heart disease.
But Amarin hoped to provide doctors with data about the effectiveness of its drug to treat people with slightly lower triglyceride levels. Last year, the FDA rejected an Amarin bid to market its pill to that patient population and denied its plan to add the data to the Vascepa product labeling. In response, Amarin filed a lawsuit, arguing any attempt to thwart its marketing would violate its free speech rights.
In its lawsuit, Amarin argued that FDA regulations are not only onerous, but prevent physicians from obtaining information from the “most knowledgeable sources — the drug manufacturers.” Four doctors joined the lawsuit, which noted they had been prescribing Vascepa off-label to people with varying levels of triglycerides.
“With more truthful and nonmisleading information readily available to healthcare professionals about the potential of Vascepa to improve cardiovascular health, this settlement serves the public interest by supporting informed medical decisions for tens of millions of patients with persistent high triglycerides,” John Thero, the Amarin chief executive, said in a statement.
Nonetheless, the settlement is unlikely to signal a rush of off-label promotion. Another expert noted that the agreement only pertains to Amarin, which had clinical trial results to support its claims about its pill. This suggests that other drug makers would likely need the same caliber of information should they consider off-label promotion.
“Amarin has an abundance of evidence concerning cardiovascular effects,” said David Rosen, a public policy lawyer at Foley & Lardner. “That may not be the case with other drugs and information a company wishes to distribute about off-label use. I think companies will be pretty conservative and make sure they have sound scientific support for any statements they make.”
Emboldened drug makers may pursue negotiations with the FDA, although some may throw caution to the wind and hope they obtain a similar court ruling if the agency objects to their marketing. On the other hand, the settlement may provide momentum for a recent proposal to create a new independent entity to review off-label claims and recommend which information drug companies should be allowed to share with doctors.
Because the FDA is worried that public health can be compromised if marketing claims aren’t backed up by solid evidence, a Duke University think tank last month suggested that a neutral third party could provide arbitration. The notion would also relieve the FDA of relying on its own strapped resources.
For its part, the FDA has repeatedly said it would hold a meeting to review the issue and, later this year, release a new guidance for companies. Specific dates, however, have not been disclosed.