State lawmakers decry FDA's proposed new drug-rules language

February 7, 2006

Washington -- Amid a number of high-profile state and federal pharmaceutical liability cases, federal regulators are proposing to insert language in a prescription-drug rule that some state officials say would help drug companies defend themselves against lawsuits.

Washington -- Amid a number of high-profile state and federal pharmaceutical liability cases, federal regulators are proposing to insert language in a prescription-drug rule that some state officials say would help drug companies defend themselves against lawsuits.

The National Conference of State Legislatures revealed the proposal in a January press release and in a letter sent by its president to Health and Human Services Secretary Mike Leavitt.

The new language reportedly appears in the preamble to a rule that governs prescription-drug labeling first proposed by the Food and Drug Administration more than five years ago. The inserted language claims that the revamped and federally approved labels on prescription drugs would pre-empt state law.

In his letter to Leavitt, NCSL President Steve Rauschenberger wrote, "This attempt to insert pre-emption 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." The group reportedly wants the language to be withdrawn or the FDA to reopen the public-comment period for the proposed rule, which was first announced in December 2000.