A few folks have asked me about the recent Second Circuit decision in United States v. Caronia, in which the court found that criminalizing the promotion of “off-label” pharmaceutical uses by a drug company sales representative violated the First Amendment. I cover a lot of commercial speech issues in the legislative context, so let me try to explain why I think the decision is probably right (“probably” being the operative term), and significant.
First, it’s important to understand how prescription drug approval works, and what “off-label” means. When a company develops a new drug, it holds clinical trials to determine if the drug is safe and when it is effective. It then applies to the Food and Drug Administration, for approval to market the drug. The FDA looks at the results of the clinical trials and says, yep, Drug X is “safe and effective” when used in certain “indications.” The company and the FDA decide on appropriate labels and directions for the drug, and it’s off to pharmacy shelves.
Now, the FDA generally does not have the power to tell doctors how to prescribe these drugs. Physicians, in their professional judgment, are absolutely allowed to prescribe drugs for ailments for which the drug was never approved by the FDA. This is “off-label” use, and this is where it gets a little complicated.
As a matter of federal law, the label on a drug package may only contain directions for indicated uses. Further, it’s illegal (criminal, actually) to sell “misbranded” drugs, which are defined as drugs that do not have directions “under which the lay[person] can use a drug safely and for the purposes for which it is intended.” The FDA’s fundamental argument is that promoting a drug for off-label use is effectively the same thing as criminal misbranding because the individual making the promotional statement is trying to sell a drug without adequate labeling. Confused? Me too.
In this case, the government contended that in several conversations with a physician (who was wearing a wire!) Caronia had promoted a drug called Xyrem for off-label uses, which violated the misbranding law.
The court then applied a recent, and somewhat controversial, Supreme Court case dealing with commercial speech: Sorrell v. IMS Health Inc. IMS Health involved a state law making it illegal to sell physician prescription records solely for marketing purposes (meaning it remained legal to sell them for any other purpose). The case is notable because the court found that the regulation was a “content- and speaker-based” restriction on speech. Under the First Amendment, government disfavor of only some speech or certain speakers is much worse than generally applicable laws that incidentally restrict speech, such as a rule making it illegal to destroy money, even in political protest.
Perhaps more importantly, however, the court found that the prosecution of Caronia couldn’t stand even if it was to find it didn’t single out a particular message or speaker. Assuming the speech restriction doesn’t discriminate, a court must ask four questions to determine if the law can stand under the First Amendment. First, is the speech false or misleading and/or does it market an illegal good or service? If so, under a case called Central Hudson v. Public Service Commission, it’s unlikely to receive any First Amendment protection. If the good or service is legal and the speech truthful, courts then move on to the other three questions: (1) does the government have a really good reason for the restriction, (2) does it directly advance that interest, and (3) does the restriction reach more speech than necessary?
The court really fixated on two things. First, and fundamentally, the speech in the case was truthful, and information on off-label uses is important for doctors to make informed decisions about such use. Second, the government’s stated interest in the case was to preserve the integrity of the FDA-approval process, and to protect consumers from unsafe and ineffective drugs. Off-label use isn’t necessarily unsafe or ineffective. So long as pharmaceutical reps do not mislead doctors or promote unsafe uses, the court found it difficult to grasp how prosecutions for simple promotion further the government’s proffered interest.
Finally, the court also was not persuaded that prosecution was the “least restrictive” way to protect consumers. Most obviously, the government actually has the power to prohibit off-label use if it wants (human growth hormone is an example). That, the court said, is the more direct and tailored way to address any problem with off-label prescriptions. I think the court does a decent job of getting at why it’s difficult to make simple distinctions between commercial and non-commercial expression when you’re talking about free speech.
For most people, advertising is a bad word. But sometimes commercial speech can help inform the “marketplace of ideas” as well as just the marketplace. This case highlights how, again assuming the speech is not misleading, pharmaceutical sales can actually help inform physicians’ medical decisions. By hampering the free flow of ideas, even profit-seeking ones, the government’s theory in Caronia could directly impair the values the First Amendment exists to further.
Two things do continue to bother me, however. First, does the government have an interest in preventing pharmaceutical company representatives from making statements about off-label uses when physicians have not separately determined that such uses might be therapeutic? The dissent is very concerned that the majority decision opens the door to precisely that. This is a completely different question than the one presented by the government in Caronia, and may very well change the analysis.
Second, does the analysis also change when you’re talking about actual advertising campaigns for an off-label use, rather than in-person informational meetings with physicians? Hopefully these questions will be addressed in future litigation, or by others following the case.
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