New Rules on Prescription Drug Preemption and State Law

State law requirements can undermine safe and effective drug use in other ways and over-warning, just like under-warning, can similarly have a negative effect on patient safety and public health.

State law actions can rely on and propagate interpretations of the act and FDA regulations that conflict with the agency’s own interpretations and frustrate the agency’s implementation of its statutory mandate. For example, courts have rejected preemption in State law failure-to-warn cases on the ground that a manufacturer has latitude under FDA regulations to revise labeling by adding or strengthening warning statements without first obtaining permission from FDA. … In fact, the determination whether Labeling revisions are necessary is, in the end, squarely and solely FDA’s under the act. A manufacturer may, under FDA regulations. strengthen a labeling warning, but in practice manufacturers typically consult with FDA before doing so to avoid implementing labeling changes with which the agency ultimately might disagree (and that therefore might subject the manufacturer to enforcement action).

Another misunderstanding of the act encouraged by State law actions is that FDA labeling requirements represent a minimum safety standard. According to many courts, State law serves as an appropriate source of supplementary safety regulation for drugs by encouraging or requiring manufacturers to disseminate risk information beyond that required by FDA under the act. In fact, FDA interprets the act to establish both a “floor” and a “ceiling,” such that additional disclosures of risk information can expose a manufacturer to liability under the act if the additional statement is unsubstantiated or otherwise false or misleading. Given the comprehensiveness of FDA regulation of drug safety, effectiveness, and labeling under the act, additional requirements for the disclosure of risk information are not necessarily more protective of patients. Instead, they can erode and disrupt the careful and truthful representation of benefits and risks that prescribers need to make appropriate judgments about drug use.

Tomorrow: State Law Actions and FDA’s Statutorily Prescribed Role