Congress Holds FDA Preemption Hearings

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ePT--the Electronic Newsletter of Pharmaceutical Technology

The Committee on Oversight and Government Reform held a hearing on whether the US Food and Drug Administration's drug and medical device regulation bar state liability claims.

Washington, DC (May 14)-The Committee on Oversight and Government Reform held a hearing on whether the US Food and Drug Administration’s drug and medical device regulation bar state liability claims.

In his opening statement, Chairman Henry Waxman (R-CA) pointed out that FDA approval of drugs and high-risk medical devices before they are marketed does not necessarily guarantee safety. Any patient harmed by these products can seek compensation under state law for damages such as medical expenses and lost wages. The hearing, therefore, examined the implications of FDA’s preemption of state liability laws. He called preemption a “radical legal doctrine being advocated by the pharmaceutical and device industries” and said the threat of liability itself is an incentive for safety.

The Supremacy Clause of the US Constitution (Article VI, clause 2) establishes the legal basis for federal preemption of state law, including “express preemption” in which federal laws are explicitly precluding state and local regulations in a particular area as well as various types of “implied preemption.”

The committee heard from parents of children who had suffered as a result of medical errors due to poor labeling, physicians and medical professionals, members of academia, as well as current and former FDA officials.

Former FDA Commissioner David Kessler told the committee that although he did not oppose federal preemption in certain cases, “there should be specific criteria governing when it is deemed appropriate,” and allowing unchecked federal preemption of state drug and device liability laws “will harm drug safety.” Kessler stated there should be three elements that should be met if FDA regulation is going to preempt state law in a given case: the agency took substantive and definitive action, there is a direct conflict between state action and agency action that would thwart the ability of the agency to achieve its statutory guide, and there is a public health reason to favor preemption.


In contrast to this testimony, Randall Lutter, deputy commissioner for policy at FDA, said that the agency is “concerned that state public product liability lawsuits that challenge FDA’s careful determination of safety, efficacy, and appropriate labeling can have detrimental effects to public health, including limiting patient and doctor choices, decreased patient access to beneficial products, and increased confusion over warnings or statements that can deter the use of beneficial medical products.”

Lutter did not argue that against plaintiff claims against products that failed to meet FDA approval, in which case manufacturers will not be protected under such claims.

“To protect public health and as a matter of law, state law claims are preempted if they challenge a design or labeling that FDA approved, after being informed of the relevant health risk, based on its expert weighing of the risks and benefits of requiring additional or different warnings,” said Lutter. “The important decisions it makes about the safety, efficacy, and labeling of medical products should not be second-guessed by the state courts.”

Preemption discussions are certain to take the stage again this fall, when the Supreme Court is scheduled to hear the drug-related case Wyeth v. Levine, in which the drug company is appealing the decision of a Vermont jury that awarded $6.7 million to a patient who had lost her arm after receiving an anti-nausea drug via an off-label injection method.