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

In November 2023, FDA published a proposed rule regarding wound products containing antimicrobials. From a legal perspective, the reason for the proposed rule is that these wound products are some of the few remaining medical devices that have not yet been classified by FDA. As a result, they have been coming to market through the 510(k) process as Class II medical devices since passage of the Medical Device Amendments, nearly 50 years ago. While it is well within FDA’s right to formally classify the products, the position it is taking in the proposed rule is not based in science or evidence, and raises serious commercial speech concerns.

Without providing a single piece of evidence, the premise of the proposed rule is that these wound products with antimicrobials are contributing to the spread of antimicrobial resistance (AMR). FDA’s position is that finalizing this rule will lead to a reduction in morbidity and mortality. However, FDA fails to provide any evidence of deaths or serious injuries associated with the long-standing use of these products. Despite the lack of support for its position that these products pose significant risk, FDA is proposing to upclassify certain wound products with antimicrobials to Class III, and for those remaining in Class II, to impose stringent special controls, ranging from an AMR risk assessment to prohibitions on truthful, scientifically accurate speech.

The Washington Legal Foundation graciously published my article analyzing the rule and discussing the implications to industry if finalized. While the comment period has closed, we will be tracking FDA efforts to finalize the rule. If you have questions about how this might impact you, or would like talk about how you can influence FDA before the rule is finalized, please reach out.