New Drug-labeling Rule Bears The Load Of Bush Appointees’ Ideology

According to a January 14, 2006 article in The Wall Street Journal (WSJ), the FDA "is preparing to declare that federally approved medication labels pre-empt state law".  Essentially, these legal claim preemption provisions would serve to protect pharmaceutical companies from personal injury and wrongful death lawsuits involving their prescription drugs.  As pointed out by WSJ staff reporter Anna Wilde Mathews, this new policy barring state liability claims "would mesh with the White House’s focus on tort reform."

It seems this new FDA policy will be included in the preamble of an important new drug-labeling rule, the primary purpose of which is not tort reform but, rather, to improve the format of the so-called "package insert", or label, for prescription drugs.  Ms. Mathew’s WSJ article states that FDA career officials are upset with the Bush Administration appointees at the agency who are responsible for inclusion of the preemption provisions in the drug-labeling rule because those provisions "may draw controversy to an important regulatory improvement [i.e., better drug labels] that isn’t itself politically divisive".  Apparently the degree of disagreement between these factions at the FDA has delayed the release of this important new rule.

This type of tort reform is not unprecedented for the Bush Administration FDA.  In recent years the FDA has filed numerous legal briefs in drug injury lawsuits asserting that such cases against drug companies should not be allowed because the federal agency’s guidelines should preempt state law.

Significantly, some federal court judges have rejected that line of reasoning.  For example, in rejecting an FDA-supported request by the drug company Pfizer to bar a lawsuit concerning its antidepressant Zoloft, a federal judge wrote that "federal labeling laws are minimum standards; they do not necessarily shield manufacturers from state law liability…. state-law protections reinforce and enhance" federal efforts to protect the public.

Moreover, the inclusion of these federal preemption provisions in an FDA regulation that is suppose to be about drug-labeling reform — not tort reform — draws attention to the issue of, in Ms. Mathews’ words, "the growing clash over the proper bounds of state and federal regulatory authority".  On this aspect, from her WSJ article:

"Yesterday, the National Conference of State Legislatures protested the move in a letter to Health and Human Services Secretary Michael Leavitt, calling it a ‘thinly-veiled attempt on the part of FDA to confer upon itself authority it does not have by statute’ and an ‘abuse of agency process’."

Hopefully, with more attention directed to this blatant political action by the Bush Administration FDA, the federal preemption provisions will be removed from the much needed drug-labeling reform regulation.

(Posted by: Tom Lamb)