In re FDA Product Jurisdiction Rule

On July 16, 2018, WLF filed formal comments with the Food and Drug Administration (FDA), urging the agency to revise its proposed regulations governing how it classifies a medical product (e.g., a drug, a medical device, or a biological product) for which a manufacturer seeks FDA marketing approval. WLF argued that the proposed regulations are inconsistent with FDA’s statutory mandate and improperly skew decision-making in favor of a drug classification. It can often be difficult to differentiate a “drug” from a “medical device”; federal law defines those two categories of medical products quite similarly. The principal distinction focuses on whether the product “achieve[s] its primary intended purposes through chemical action.” If so, the product is a drug; if not, the product usually is classified as a device. WLF’s comments argue that FDA, in its proposed regulations and in prior filings, has been interpreting “primary intended purposes” in an overly expansive manner.