A few weeks back I blogged here about pharmaceutical manufacturer Amarin’s lawsuit aiming to allow it to market a fish-oil based drug for a use not approved by the FDA. The FDA denied approval because it concluded the drug had no demonstrated therapeutic benefits for that use, but Amarin claims a First Amendment right to market it for the use anyway.
Today Amarin, and by extension big Pharma, won an important early battle in that case when the U.S. District Court for the Southern District of New York, in a 70+-page opinion by Judge Paul Engelmayer, ruled that Amarin was entitled to a preliminary injunction allowing it to promote the drug for the unapproved use.
I won’t attempt to explain everything in the opinion in a short blog post, but the nub of it is this: Judge Engelmayer held that Amarin was likely to prevail in its argument that when a drug manufacturer has obtained approval to market a drug for one use, the First Amendment entitles it to market the drug for unapproved uses as well unless the FDA can prove that its marketing is false or misleading (or, perhaps, would promote an unsafe use of the drug). The ruling thus effectively reverses the Food, Drug & Cosmetic Act principle that the burden is on a manufacturer to prove a drug safe and effective for a particular use before it may market the drug for that use.
Judge Engelmayer’s opinion rests in large part on his view that prohibiting off-label marketing penalizes speech and nothing more, or, as he puts it, that the only “actus reus” (i.e., criminal act) in such a case is the promotional speech. Judge Engelmayer concludes that United States v. Caronia, a recent opinion of the U.S. Court of Appeals for the Second Circuit (which controls cases in New York federal courts), requires him to find that Amarin can market the drug for an unapproved use because Caronia held that a person can’t be prosecuted based only on speech promoting an off-label use of a drug.
I think the judge has overlooked that, unlike the defendant in Caronia—an individual who was indeed being prosecuted for no more than speaking—a drug manufacturer does engage in a non-speech “actus reus”: It is manufacturing and selling a drug (or in the words of the statute, introducing it into commerce) for a particular purpose. Its speech is used as the basis of an inference of the purpose for which it is selling the drug, and prohibiting selling a drug for a particular purpose is not the same thing as prohibiting speech by itself.
The judge apparently didn’t get an answer that satisfied him when he asked point-blank at argument what non-speech “actus reus” was implicated in marketing a drug for an unapproved use. And in fairness to the judge, the pharmaceutical industry and its lawyers (and some neutral observers as well) have successfully fostered the impression that Caronia gives broad protection to off-label marketing. As a general matter, of course, district judges follow the prevailing direction of the wind in their circuits. It may take the Second Circuit to undo the damage that broad readings of its opinion in Caronia have done.
Meanwhile, lawsuits like this one are, as the FDA rightly told the court, “a frontal assault … on the framework for new drug approval that Congress created in 1962.” The court’s answer is none too reassuring: “The short answer is that the FDCA’s drug-approval framework predates modern First Amendment law respecting commercial speech.” In other words, times have changed, and the FDCA, like other attempts to rein in corporate excess, has to bow to the new paradigm.
Kinda makes you wonder about “modern First Amendment law respecting commercial speech.”