Can Speech by FDA-Regulated Firms Ever be Noncommercial?

Abstract:     
This Article considers whether speech by pharmaceutical, medical device, and other FDA-regulated companies can ever be noncommercial and thus subject to heightened protection under the First Amendment. Since the U.S. Supreme Court first recognized a right to commercial speech in 1976, there have been 24 published federal judicial opinions in which an FDA-regulated firm has argued that its speech was protected. Courts have categorized the speech as commercial in all but two cases, neither of which involved FDA rules or enforcement.

I examine the tests and factors courts claim they use when making this threshold distinction, then identify the various factors and indicia of commercial speech that they actually use. I find that courts often use the speaker's commercial identity as a proxy for commercial intent, which otherwise is the most salient factor. The Article then considers various forms of speech by FDA-regulated companies that blur the distinction between commercial and noncommercial speech, including publicity, statements via new media, speech through experts and intermediaries, and scientific speech, including speech about off-label uses for their products.

The Article concludes that each of the various factors courts use to distinguish commercial from noncommercial speech would have to align perfectly for courts to give it heightened First Amendment protection.

Number of Pages in PDF File: 34

Keywords: free speech, first amendment, FDA, pharmaceutical, drug, device, regulation, commercial speech, IMS, sorrell

Accepted Paper Series