In May, Amarin Pharma Inc. filed a lawsuit over its First Amendment right to distribute information about unapproved uses of its fish oil prescription, Vascepa. On June 8, in response to Amarin’s free speech challenge, the U.S. Food and Drug Administration (FDA) appears to be trying to derail that suit by releasing a letter to Amarin saying that it will allow the company to make a number of off-label comments about the fish oil prescription medication Vascepa.
In that letter, the FDA concluded that existing FDA guidance permitted Amarin to (1) communicate about clinical trials related to unapproved uses of Vascepa and to (2) respond to unsolicited requests for off-label information; but determined that existing guidance did not permit the company to claim that the active ingredient in Vascepa reduces the risk of coronary heart disease based on the findings of supportive, but non-conclusive research alone. The FDA clarified that that this type of claim could be made only if Vascepa was repackaged as an over-the-counter dietary supplement, instead of a prescription medication. The letter also reminded Amarin (and the court) that the FDA is planning to issue new guidelines regarding the dissemination of off-label information on medicines.
The FDA does not regulate commercial speech for over-the-counter supplements to the same extent that it regulates commercial speech for prescription medications. In 1999, the DC Circuit ruled in Pearson v. Shalala that government agencies like the FDA must satisfy a higher First Amendment standard in order to suppress commercial speech for dietary supplements. The court in Pearson reasoned that public policy favors a “preference for disclosure over outright suppression” with respect to commercial speech for over-the-counter supplements.
The FDA’s letter is likely an attempt to dodge Amarin’s closely watched constitutional challenge by agreeing that most of Amarin’s proposed speech is permissible under existing FDA guidelines. Because the FDA’s letter is replete with qualifications and rejects part of Amarin’s request, the letter provides no evidence that the FDA has changed its position on the subject. It does appear, however, that in this instance, the FDA is not eager to test the First Amendment waters.
*Admitted only in Texas. Practice supervised by principals of the firm admitted in the District of Columbia.