PROPOSED FDA LABELING RULE COULD BE CHALLENGED BY EXECUTIVE ORDER

State lawmakers are considering a legal challenge to a proposed FDA rule, which they argue improperly limits state authority to require more stringent labeling requirements.

The National Conference of State Legislatures (NCSL) argues that the agency's alleged plan to preempt state authority over drug labeling is in direct violation of Executive Order (E.O.) 13132 on Federalism. The group may use the order to sue the FDA to force another round of public comments before the agency could issue its final rule, said NCSL staffer Joy Wilson.

The states group contends the FDA's proposed labeling rule would essentially limit industry liability under state product liability laws by allowing a federal labeling standard to take precedence. States would be unable to bring "failure to warn" claims under state common law if the federal rule preempts state standards, said NCSL staffer Susan Frederick. The NCSL believes that federal rules are meant to be the very minimum of protectiveness and that state law is supposed to represent the most protective standard.

E.O. 13132 requires that the federal government first consult with state and local governments before finalizing rules that present a potential conflict between state and federal law. But the agency supposedly will soon issue a final labeling rule that will preempt state laws without providing state and local governments the ability to comment, noted Frederick and Wilson.

According to a recent NCSL letter to HHS Secretary Mike Leavitt, the agency's decision to issue the final rule represents "a thinly-veiled attempt on the part of FDA to confer upon itself authority it does not have by statute and does not have by way of judicial rulings." The Food, Drug & Cosmetics Act does not give the agency authority to preempt state law in the area of prescription drugs, the letter states.

The group added that the agency's decision not to go through another round of public comments "amounts to an abuse of agency process and a complete disregard for our dual system of government."

FDA officials could not be reached for comment. PhRMA declined to comment until the final rule is issued, an association spokeswoman said.