Is off-label use of medication a matter of First Amendment rights?
Kinda, as an Incidental Economist blog points out.
It centers around Vascepa, a prescription-only “fishy” oil prescribed for lowering triglycerides that’s irritating the FDA. On Friday, a federal judge told the FDA that it couldn’t prevent Amarin Pharma – maker of the “fishy” oil from discussing the research it’s conducting on off-label use of this drug. Freedom of speech.
Clinical trials have shown that Vascepa lowers triglycerides in folks with very high levels of the lipid – and is now being used broadly to reduce heart disease. The FDA is taking exception to this, however, because while the drug may reduce triglyceride levels, there isn’t proof that lowering these levels actually prevents heart disease. As the blog points out:
FDA doesn’t see it that way. It’s not naïve. It knows that Amarin isn’t sharing information about fishy oil out of the goodness of its heart. Amarin wants doctors to prescribe it for off-label uses. And the agency thinks that promoting off-label uses undermines the integrity of its review process. If manufacturers were free to tout off-label uses, they wouldn’t have much incentive to seek FDA approval of those uses. Since rigorous testing sometimes shows that off-label uses are ineffective or harmful, rampant evasion of FDA approval could end up hurting patients.
Indeed, manufacturers wouldn’t have any reason to get approval from the FDA if they had free reign to broadcast off-label medication use. Pharma being able to evade FDA approval could lead to a lot of patient harm – because further clinical testing can actually show that off-label use can be ineffective.
At core, though, this is also a real conflict between the government and free speech – and it’s happened before. A case called United States v. Caronia found that drugmakers have the First Amendment right to non-misleading and truthful information about its drug. Here’s the concern, however, from that precedent:
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
From the drug companies’ perspective, however, the fishy oil case shows why Caronia is almost as good as a Supreme Court decision. Anytime FDA threatens to penalize a drug company for sharing information about off-label uses, the company can run to a federal court in the Second Circuit to get an injunction. Even if the company is headquartered elsewhere, all it has to do is find a doctor in New York to serve as a co-plaintiff. Caronia may technically apply only in the Second Circuit, but the decision has national effects.
