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FDA settles with drugmaker in fish-oil drug marketing case

WASHINGTON – The maker of a prescription fish-oil drug says it has reached a legal settlement that will allow it to promote unapproved uses of its drug for lowering fat levels.

The closely watched case between Amarin and the Food and Drug Administration could strengthen the drug industry’s hand in the ongoing debate over promoting drugs for uses that have not been declared safe and effective by regulators.

But the FDA said Tuesday the settlement is “specific to this particular case and situation,” and did not mark a new legal precedent.

“The FDA is responsible for protecting the American public by helping to ensure medical products meet the rigorous legal standards for safety and effectiveness for their intended uses,” the agency said in a statement.

Still, pharmaceutical experts said companies would likely pursue more aggressive legal action against FDA, in light of the settlement.

“We would expect companies throughout the country to ask courts to provide the same legal reasoning,” said attorney John Fleder, who was not involved in the case.

In August, Amarin won a surprise victory over the FDA when a U.S. District Court judge ruled that the company had a First Amendment right to distribute journal articles about unapproved indications for Vascepa.

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