Kessler: FDA pre-emption is of no benefit to public

FDA pre-emption of “failure-to-warn” state lawsuits over drug risks does nothing to benefit the agency or the public and can prevent information that is helpful to the FDA, healthcare providers, and consumers from coming out, say commissioner David Kessler and Georgetown Law professor David Vladeck in the Georgetown Law Journal. 

While there has been a “steady stream” of such cases against drug companies brought by consumers injured by FDA-regulated drugs, the FDA has stayed on the sidelines, they report, and courts have decided them under the ordinary rules that govern state damages actions, with the question of preemption rarely, if ever, arising.

But Kessler and Vladeck say there are both legal and practical problems with the FDA’s new position. They say the FDA’s pro-pre-emption arguments are based on a reading of the Federal Food, Drug, and Cosmetic Act that, in their view, understates the ability of manufacturers to change labeling unilaterally to respond to newly discovered risks or to seek labeling changes from the FDA.