Editor’s Notes:

The FDA, as expected, has issued a new labeling rule that tries to preempt state tort claims, at least in certain cases. If effective—and there is some question about whether state courts will recognize the agency’s authority—it could cancel out much of the frivolous litigation that now handicaps the pharmaceutical industry.

The agency yesterday declared the pre-emption policy in the preamble of a regulation that lays out a new format for drug labeling. The FDA's move drew quick complaints from plaintiff attorneys and state officials, who argued that the agency was overstepping its bounds. But drug makers said that they supported the FDA's decision and that the agency should determine how safety information is communicated.

In the rule, the FDA said that under the law, its approval of labeling "pre-empts conflicting or contrary state law," including statutes that deal with requirements to warn consumers about potential side effects. The rule gave specific cases in which such pre-emption would apply, but added that it was true in "at least" those situations. It also said pre-emption would apply to cases against health-care providers that deal with claims that they failed to tell patients about a risk "beyond what is included in the label."

The move is likely to spark a fight in Congress. Republicans won't be eager to move against the FDA, so it isn't clear if a bill would make much headway, because they are in the majority. Sen. Edward M. Kennedy (D., Mass.) called the pre-emption language an "abuse."

Actually, the only abuse we can see is that plaintiffs’ lawyers have portrayed vaccine and pharmaceutical companies as the next “Big Tobacco.” If there is any area where the federal government’s commerce power should trump state laws, this is it. Today, the industry is subject to endless litigation based on a patchwork of state laws. This allows plaintiffs’ attorneys to “forum shop” for friendly juries and judges, impedes pharmaceutical innovation, and drives up the cost of new medicines.

Jim Copland, director of the Manhattan Institute’s Center for Legal Policy, said in response to the FDA’s new labeling that “the FDA's decision that its labeling decisions preempt many state causes of action is a common-sense interpretation consistent with the constitutional principle that the federal government has primary authority over regulating interstate commerce. The FDA goes through an extensive review process to determine the precise labeling that is most appropriate to warn consumers, and states should not have the power to interfere with these decisions by allowing lay juries to second-guess the FDA.”