Monday, January 16, 2006

FDA - a "thinly-veiled" move is seen through!

The FDA wants to propose a rule on prescription drug labeling that would preempt state drug product liability laws, said the National Conference of State Legislatures Friday in a press release.

The FDA is resurrecting a proposal that was dormant for about five years and seeks to add language that would nullify state product liability laws, the NCSL said.

Previously, Congress and courts refused to grant these powers to the FDA. The FDA called the NCSL with its intentions to insert the preemptive language. The NCSL said the FDA did not give state legislators a copy of the language it wants added to its final 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 NCSL President and Illinois Senator Steve Rauschenberger in a letter to U.S. Department of Health and Human Services Secretary Mike Leavitt. “This amounts to an abuse of agency process and a complete disregard for our dual system of government.”

So that's a "no" then, is it Steve?

Insiders' view: Big Pharma would like this change as it could potentially weaken future US State product liability cases.

Insurance Journal

2 comments:

Anonymous said...

FDA?

Limit liability?

Isn't the FDA's role one of public safety?

How on earth could limiting the liability of big Pharma improve public safety?

FDA gone to the Dark Side they have.

Anonymous said...

Gone to the Dark Side? They went a long time ago. Reminds me of a quote from someone responding to an article titled "Is Academic Medicine for Sale?" The response was "No, its current owner is quite happy with it." (I'm pretty sure I read this in Dr. Jerry Avorns Powerful Medicines Same could be said for the FDA