More than once we’ve said that we read law review articles so you don’t have to. We separate the wheat from the chaff. The wheat is scarce. That is because law review articles usually drown the little bits of objective description of what the cases DO say with enormous chunks of pie-in-the-sky suggestions of what the cases SHOULD say. Such suggestions almost always go nowhere. When they do go somewhere, as in the famous long-ago Fordham Law Review article that advocated market-share liability, they go someplace very bad. Have we mentioned that law review articles, whether written by professors or students, tend to be pro-plaintiff?
But the law review article at issue today, Conners, “Illuminating the Off-label Fable: How Off-label Promotion May Actually Help Patients,” 13 Journal of Law, Economics & Policy 91 (Winter 2017), is one you might actually want to read yourself. It is a sane, clear-eyed appraisal of why off-label use of drugs or devices can be necessary, why truthful communication about benefits of off-label use can be necessary, and why current FDA regulation of off-label communications is incoherent and harmful to patients.
The first paragraph of the law review article sets the agenda nicely:
“The current framework of the off-label use of pharmaceuticals is as follows: physicians are free to prescribe off-label as they see fit; the Food and Drug Administration (“FDA”) acknowledges the value of off-label use (going so far as to say physicians could have an obligation to prescribe off-label in certain circumstances); but, per FDA policy, drug manufacturers are restricted from sharing truthful and non-misleading information about off-label uses. The scheme, on its face, is inconsistent and, as could be expected, raises significant concerns regarding free speech, consumer protection, and public safety.”
The article sets forth –
* the importance of off-label prescriptions (one out of every five)
* the FDA’s position that “when a manufacturer promotes a drug for a use that has not been approved, the manufacturer is guilty of misbranding and as having an intent to defraud or mislead”
* the evolving protection of commercial speech promoting pharmaceuticals, from Virginia Board of Pharmacy to Thompson to Sorrell to Caronia to Amarin to Pacira. Courts keep relying on the First Amendment to shut down the FDA’s efforts to shut down truthful off-label communications, and the FDA keeps pretending that the court rulings are case-specific and do not affect the FDA’s overall policy against off-label promotion.
The article makes the FDA seem either clueless or defiant.
Last week, we discussed a Ninth Circuit case about the intersection of the First Amendment and regulation of alcohol advertising. We wondered whether the court’s ruling had any implications for regulation of drug marketing. We also wondered whether the recent SCOTUS decision in Matal, which struck down the anti-disparagement provision in copyright law, had any implications for regulation of off-label communications. We are still wondering. The Conners article does not spend as much time wondering about the future path of first amendment jurisprudence. Instead, it makes the point that the FDA’s truculence and incoherence on the issue are bad for patient welfare. Here are the main points:
* barriers to truthful off-label communications ensure that poorer patients will get less access to life-saving medications.
* regulatory compliance has been reduced to guesswork
* uncertainty about the scope of regulation reduces investment in new drug research
The article reminded us of something we learned in our Elements of the Law class taught by Edward Levi at the University of Chicago Law School back in 1982. Levi introduced us to the writings of Jeremy Bentham, the utilitarian philosopher. Bentham favored freedom of expression, abolition of slavery, equal rights for women, and decriminalizing homosexual acts. On the other side of the ledger, he wrote an article mocking the Declaration of Independence, and he called the concept of natural rights “nonsense upon stilts.” We studied Bentham in our Elements class because Bentham eloquently made the point that the law needed clear ex ante rules to guide future conduct. Otherwise, all we have is “dog law.” When you come home from work and find that Fido has piddled on the kitchen floor, there is a temptation to whack Fido’s behind with a rolled up Times, Inquirer, or Picayune. Bad dog! But poor Fido does not put the punishment and offense together. FDA punishment of off-label communications is sort of like that. It is not predictable.
Or maybe we’ve got the analogy wrong. Maybe it is the FDA that is piddling on the First Amendment.