Most OTC Drug Warnings Subject to Preemption: Attorney

Attorney James Beck (Reed Smith) says that his review of court cases and other sources indicates that preemption should apply to almost all warnings related to over-the-counter products for which there is at least a tentative monograph. “The same combination of a ‘sameness’ requirement and absence of any changes being effected exception for ‘new’ information exists for OTC products, as it does for generics,” he writes in an online blog post.

He says that even though monographs may be labeled tentative, they contain threats of administrative action should they be deviated from during the period before they are finalized. They also use mandatory language, such as the words “must” and “required.”

While FDA reserves the right to change monograph requirements, Beck writes, in most cases the design and language of warnings in them cannot be unilaterally changed by regulated persons, and deviations from them are subject to agency enforcement action. “Plaintiffs may not like this system,” he says, “but it is what it is. State law cannot ignore the basis on which these products have been sold for decades without putting manufacturers in an ‘impossible’ position of being punished with liability for doing what FDA requires them to do.” Beck also raises the possibility that state common law could say that the tentative monograph system is a bad system that doesn’t result in safe products and thus manufacturers cannot avoid liability, whether a particular requirement is mandatory. “That would amount to telling FDA-regulated manufacturers that they cannot sell their products in accordance with the regulatory regime that FDA has created,” he concludes. “Such ‘stop selling’ claims are themselves impliedly preempted.”