FDA settles with drugmaker in fish-oil drug marketing case

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.

"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.

[...] companies' ability to distribute independent materials about their drugs — such as medical journal articles — has been subject to years of legal debate centering around the limits of "commercial speech."

Fish oil is thought to lower heart disease risk, though no definitive studies have yet established that benefit.