FDA Plants Oversight Flag On Amarin Trade Claim Against Omega-3 Ingredients
This article was originally published in The Rose Sheet
FDA Chief Counsel Rebecca Wood says Amarin's request for an ITC investigation necessarily turns on questions of drug and supplements policy, where it is the expert and authorized agency. If successful, Amarin's move could encourage others to similarly seek alternative forums for action.
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As Amarin did in complaint to ITC for a fair trade investigation and appeal to Federal Circuit. it framed its petition for a writ of certiorari to Supreme Court as a compliant pharma firm that invested in research for approval of a drug asking federal agencies to enforce laws to stem competition from products it claims are labeled as supplements but should be deemed unapproved drugs.
In an amicus opposing Amarin's petition in federal court for an order that the US ITC investigate its fair trade complaint targeting certain omega-3 oil ingredients, DoJ says the drug firm is attempting private enforcement of the FDC Act. The act "commits enforcement exclusively to the federal government to ensure that complex enforcement decisions are made with the benefit of FDA's scientific and regulatory expertise," DoJ argues.
Amarin's petition to the Federal Circuit Court to direct ITC to investigate its complaint that some omega-3 ingredients are unapproved drugs leans on Supreme Court decisions that compliance with FDA regulations in cosmetic and food labeling does not preclude litigation alleging the information rendered a product an unapproved drug or represented false advertising.