Richard A. Samp retired on December 31, 2019 after a three-decade career as Washington Legal Foundation’s Chief Counsel.

The Food and Drug Administration announced in December its launch of CURE ID, an Internet repository for information about off-label uses of FDA-approved medical products. FDA asserts that “crowdsourcing” off-label information will assist healthcare providers by offering guidance on treating difficult-to-treat diseases. But FDA’s active promotion of off-label speech fatally undermines what was left of its already shaky claim that it is entitled to suppress truthful speech by drug manufacturers.

The Supreme Court has long recognized that the First Amendment, subject only to narrow and well-understood exceptions, bars the government from imposing content-based controls on speech. FDA has nonetheless asserted authority to severely restrict what drug manufacturers can say about their products, even speech that is neither false nor misleading. In general, FDA limits manufacturer speech to information contained on a product’s FDA-approved labeling. Courts have been highly skeptical of FDA’s various rationales for its restrictions on truthful manufacturer speech. Those rationales have been rendered unintelligible by FDA’s decision to facilitate the very same off-label speech by others.