In regulatory news:

Amarin Pharma (Amarin) has preemptively filed suit against the FDA for what it claims are unfair practices stemming from the agency’s policies about drug-makers directly discussing “off label” uses with prescribers. Amarin’s only product, Vascepa, which is used for patients with extremely high triglycerides, is the issue at hand, as the FDA previously refused to expand its approved applicable population to those with “persistently high” triglycerides. Although courts have sometimes favored big pharma in these cases, the FDA takes a staunch position on its authority to set limits on information sharing, including the expansion of indications resulting from “off label” use.

Read more from JD Supra via Workers’ Compensation Institute 360 here.

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