Congress To Hold Preemption Hearing Tomorrow
5 CommentsBy Ed Silverman // May 13th, 2008 // 7:00 am
A seemingly arcane legal concept is quickly gaining a great deal of attention - and for good reason. At issue is the notion that FDA approval supercedes state law claims challenging safety, efficacy, or labeling. Drugmakers and the FDA argue preemption exists by maintaining agency actions are the final word on safety and effectiveness.
This fall, the Supreme Court will hear a case - which involves a Wyeth drug (here’s the back story) - and the ruling will determine whether patients can sue a drugmaker through state law when a product has already been approved by the FDA. To get in front of the issue, the House Committee on Oversight and Government Reform will explore the debate.
The witness includes some marquee names - actor Dennis Quaid, who is suing Baxter; former FDA commish David Kessler, who opposes preemption and New England Journal of Medicine editor Greg Curfman, another preemption opponent. In fact, several of the eight witnesses appear not to be crazy about preemption. And there’s no one from pharma to schedule to appear, which would make for a lively discussion.
In any event, we hope to offer a live webcast when the hearing gets under way at 10 am EST, so do stop by and watch Henry Waxman in action. (He chairs the committee).
Nathan
Let me get this strait: Congress is holding a hearing on preemption but is not hearing from anyone in support of preemption? What kind of a hearing is that? It sounds like more like a witch-hunt than a hearing…
Marusa
It’s not a surprise that anyone from Pharma isn’t showing up. All you have to do is read the news including WSJ to see why preemption is a farce.
Justice in Michigan
Hi Nathan and Marusa - You’ve both jumped to an inaccurate conclusion. Here is the announcement from the Committee.
Panlists Maizel, Ruther, and Clark will almost certainly be pro-preemption. Curfman’s position is not without “nuance.” And frankly, I’m not sure where the Quaids fit (other than adding star power) into the issues at hand.
A witchhunt is planned for another occasion….Perhaps going after dentists who ask a lot of questions while your mouth is splinted up…..
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Should FDA Drug and Medical Device Regulation Bar State Liability Claims?
Committee on Oversight and Government Reform
Wednesday, May 14, 2008, 10:00 AM at 2154 Rayburn House Office Building
http://www.oversight.house.gov/
Witnesses: Actor Dennis Quaid and his wife Kimberly, parents of
newborn twins, Thomas Boone Quaid and Zoe Grace Quaid, who were
victims of a heparin overdose; William Maisel, director of the Medical
Device Safety Institute, Department of Medicine, Beth Israel Deaconess
Medical Center, Boston; Aaron Kesselheim of the Harvard Medical
School’s Division of Pharmacoepidemiology; David Kessler, professor of
pediatrics and epidemiology and biostatistics at the School of
Medicine, University of California, San Francisco; David Vladeck,
professor of law at the Georgetown University Law Center; Gregory
Curfman, editor of the New England Journal of Medicine; Christine
Ruther, president and chief engineer for C&R Engineering, Inc.; and
Utah State Representative David Clark (R) of the National Conference
of State Legislatures.
Justice in Michigan
Also this re: back story - the hearing concerns both drugs and devices, and the Supreme Court has _already_ ruled upholding preemption for devices (Riegel case). So it’s not only in anticipation of Levine, which folks from device industry are represented.
Nathan
Thanks for the clarification Justice.