FDA, Medical Communications, and Intended Use—A New Challenge to First and Fifth
Amendment Constraints on Government Power

Coleen Klasmeier


This Article aims to fill a gap in the scholarly literature relating to the federal government’s regulation of drug and medical device manufacturers’ speech regarding uses of their products that have not been approved by the U.S. Food and Drug Administration (FDA). Academics have noted the conflict between enforcement of the Federal Food, Drug, and Cosmetic Act (FDCA) against individuals and companies engaged in truthful, non-misleading communications about off-label uses, and First and Fifth Amendment prohibitions on ambiguous regulatory standards that govern speech. But there has been no comprehensive analysis of the complex web of policies that FDA has established over decades, purporting to grant “safe harbor” status to certain forms of manufacturer communications about off-label uses of medical products. Such an assessment is necessary because FDA has completed a rulemaking proceeding to amend the regulation defining intended use, a foundational concept that determines both whether a product is subject to regulation as a drug or device and the scope of a manufacturer’s FDCA liability for off-label promotion. Under the regulatory amendments, FDA asserts, even accurate scientific speech about off-label uses can be used as evidence of intended use, and therefore can be the basis for enforcement under the FDCA. This Article provides a detailed account of FDA’s creation and repeated modification of policies allowing off-label communications. The purpose of this account is to provide a resource that is not otherwise available in legal publications. It is also intended to call attention to the impact of the new definition of intended use on the safe harbors for manufacturers’ medical communications and the associated constitutional issues.