Help
Worried About Preemption? There’s A Petition
129 Comments
By Ed Silverman // August 26th, 2008 // 8:30 am
Preemption may still not be the sort of discussion you hear by the pool, at the golf course or while walking the supermarket aisles, but the issue is, nonetheless, gaining traction as a Nov. 3 review by the US Supreme Court grows ever closer. (Back story with loads of links for summer reading).
What is preemption? The legal notion that FDA approval of a drug supercedes state law claims challenging safety, efficacy, or labeling. Drugmakers and the FDA argue that preemption exists by maintaining the agency’s actions are the final word on safety and effectiveness. The court’s decision, therefore, is being closely watched because its ruling will determine whether patients can sue a drugmaker through state law when a product has already been approved by the FDA.
And so, now, an ad-hoc group of individuals -who, we are told, coalesced while discussing the topic here at Pharmalot - have posted an Internet petition in hopes of generating enough public awareness to stir a societal debate and, possibly, influence the decision-making this fall. The effort, by the way, was organized by Hank Greenspan, who helped lead a group called Justice In Michigan, which has fought against a state law that bars citizens from filing product-liability lawsuits against drugmakers.
Petition: http://www.ipetitions.com/petition/fdap ... edicine/?e
