Bioethics Blogs

Did the Supreme Court Explode Drug Regulation While No One Was Looking? Don’t Panic!

Roland Nadler

Back in 2012, CLB Fellow Matt Lamkin blogged about a case that still haunts our nightmares. In United States v. Caronia, the U.S. Court of Appeals for the Second Circuit held that FDA regulations prohibiting off-label marketing of drugs violate the First Amendment … or, at least, hinted at that conclusion. The majority didn’t quite come out and squarely declare drug advertising regulation unconstitutional, much to our relief.

The regulatory state as we know it dodged a bullet in Caronia; ever since, Matt and I have been hoping and praying that the Supreme Court would never take up the case. We scanned the dockets for anything Caronia and, mercifully, it never appeared.

… or did it? What if the Supreme Court snuck Caronia’s holding into a different case, right beneath our noses? What if its holding was even broader than Caronia, threatening not just drug regulation but practically all advertising regulation and professional oversight? What if that case was decided 9-0? What if a leading expert said of the decision that its logic “would roll consumer protection back to the 19th century” … ?

Have you woken up in a cold sweat yet? This isn’t a bad dream. The case is real, and its name is Reed v. Town of Gilbert. But it’s also not quite the boogeyman it sounds like. My view is that the decision certainly goes “bump” in the night, but, much like the monster you once could have sworn lived under your bed, its threat is more imagined than real.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.