States Claim FDA Drug Labels Would Undermine State Product Liability Laws

January 15, 2006

The National Conference of State Legislatures has accused the federal Food and Drug Administration of attempting to preempt state prescription drug product liability laws despite Congress and the courts’ refusal to grant them such power.

The state group says the agency is trying to expand its own authority by sneaking language into a revised prescription drug labeling rule.

“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 Illinois Sen. Steve Rauschenberger, who is NCSL president, in a letter to U.S. Department of Health and Human Services Secretary Mike Leavitt.

Rauschenberger said the FDA is resurrecting a five-year old proposed rule on prescription drug labeling. When the rule was first proposed back in Dec. 2000, both FDA and NCSL agreed the changes would have no impact on state product liability laws, accordingto the state lawmakers.

But now NCSL says the FDA has plans to insert language that would negate state product liability laws regarding prescription drugs. He said the FDA has refused to provide state legislators with a copy of its language. Additionally, NCSL says the FDA is refusing to republish the new language so that it 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.”

Currently, there are several high-profile product liability cases that would be affected should the rule go into effect, according to NCSL.

NCSL is a bipartisan organization that serves the legislators and staffs of the states.

Source: National Conference of State Legislatures

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