FDA and pharma company Amarin settle lawsuit on “off-label” promotion

The Food and Drug Administration and Amarin, the manufacturer of a prescription fish-oil drug, have settled Amarin's lawsuit challenging the FDA's authority to restrict the company from touting its product for an unapproved use.

The Washington Post reports that the FDA said the settlement is “specific to this particular case and situation,” and did not mark a new legal precedent." But the settlement leaves in place a district court decision that is skeptical of the FDA's authority to protect patients when drug companies want to promote drugs for uses that have not been approved as safe and effective.

The settlement is here. New York Times coverage of the settlement is here.

Our previous posts about Amarin's first amendment theory and the implications for public health are here, here, and here.

Leave a Reply

Your email address will not be published. Required fields are marked *