January 13, 2006
Proposed FDA Rule Preempts State Product Liability Laws
Back-door approach seeks powers denied by Congress and the courts
WASHINGTON, D.C. - The Food and Drug Administration is attempting a back-door approach to preempt state prescription drug product liability laws despite Congress and the courts' refusal to grant them such power, says the National Conference of State Legislatures.
"This attempt to insert preemption language is 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 ruling," said NCSL President and Illinois Senator Steve Rauschenberger in a letter to U.S. Department of Health and Human Services Secretary Mike Leavitt.
FDA is resurrecting a proposed rule on prescription drug labeling that has laid dormant for nearly five years and plans on inserting language that would negate state product liability laws regarding prescription drugs. Currently, there are several high-profile product liability cases that would be affected should the rule go into effect.
The notice of proposed rulemaking (NPRM) on Content and Format of Labeling for Human Prescription Drugs and Biologics; Requirements for Prescription Drug Product Labels (Docket Number 00N-1269) was first issued December 22, 2000. At the time, FDA asserted and NCSL concurred that the proposed rule did not contain any language that would preempt state or local laws.
FDA notified NCSL by phone of their intentions to insert the preemptive language and, to date, has failed to provide state legislators with a copy of the offending language. Additionally, FDA is refusing to republish the new language which would be subject to an additional comment period.
"FDA seeks to insert this currently unavailable language into its final rule without going through the requisite comment period that should be accorded to such an important shift in agency position," said Rauschenberger. "This amounts to an abuse of agency process and a complete disregard for our dual system of government."
NCSL is the bipartisan organization that serves the legislators and staffs of the states, commonwealths and territories. It provides research, technical assistance and opportunities for policymakers to exchange ideas on the most pressing state issues and is an effective and respected advocate for the interests of the states in the American federal system.
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