Wound Products, Antimicrobial Resistance, and Commercial Speech: FDA’s Solution in Search of a Problem

To borrow (at least in part) from Shakespeare, “FDA doth protest too much, methinks” when it comes to its proposed rule that would impose more stringent regulatory controls of wound products. These protestations begin with FDA maintaining that wound products with antimicrobials may contribute to global concerns about antimicrobial resistance (AMR), continue on with discussions of whether, despite decades of use, there is adequate evidence of clinical utility, and, for the finale, conclude with FDA’s attempt to strip manufacturers of the ability to use certain words or phrases to describe their products-language that, for many products, has been used for decades.
In the end, the proposed rule seems to be a solution in search of a problem—a solution raising, at minimum, violations of the Administrative Procedure Act (APA) as well as the commercial speech protections provided by the First Amendment of the United States Constitution.