I recently posted my new article “When Truth Cannot Be Presumed: The Regulation of Drug Promotion Under an Expanding First Amendment“. The article is forthcoming next year in Boston U. Law Review, but I have plenty of time to make revisions. So I would love to get the feedback from BillofHealth readers.
One of the preliminary themes of the article is that the Food, Drug, and Cosmetic Act is predicated on the drugmaker’s own intent that a substance be used to treat a disease. The exact same chemical compound can be sold for other purposes without any FDA oversight. But once the drugmaker intends that the substance be used as a drug, it becomes a drug as a matter of law, and then each intended use must be proven as safe and effective to the FDA. For example, turpentine has had this dual-life as a paint-thinner and as “Hamlin’s Wizard Oil,” for which “there is no sore it will not heal, no pain it will not subdue.”
This intent-based system of regulation sets up a confrontation with the First Amendment, since the drugmaker’s own speech is often the best evidence of its intent. It is a pretty big confrontation too, since the intent concept is the very predicate for the entire FDA regulatory regime. On the other hand, it is hard to conceive of an alternative threshold for what counts as a drug. There was a time (e.g., the 1993 Mitchell case) when a ConLaw scholar could confidently say that such evidentiary use of speech presents no First Amendment problems at all, but the current Supreme Court has been eager to dispense with such formalisms (c.f., the 2012 Alvarez case).
In my research on this point, I found a few other intent-based regulations that metaphysically transform things into the objects of a regulatory regime. For example, the distinction between whether the Federal Aviation Administration regulates your family station wagon depends on whether the carmaker intends it to fly. (See note 20 of the paper.) Perhaps a broader analysis is in order. If the First Amendment undermines this mechanism of regulation, what other similar regulatory regimes may be threatened?