White House Backs Wyeth On Preemption
8 CommentsBy Ed Silverman // June 6th, 2008 // 10:29 am
Not sure how many people are surprised by this move. In any event, the US Solicitor General has filed a brief with the US Supreme Court, arguing there is good reason to support preemption, which says 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. However, in a case heard by the Vermont Supreme Court, Diana Levine successfully argued that, even though labeling for Wyeth’s Phenergan complied with FDA requirements, the adequacy of the warning still wasn’t established. She lost an arm and was awarded $6 million.
Levine’s attorneys contend Wyeth wasn’t prevented from adding or strengthening the warning on the label, even though the FDA rejected a proposed change. The Supreme Court ruling could, therefore, determine whether patients can sue a drugmaker through state law when a product has already been approved by the FDA.
In its brief, the government argues that “labeling requirements are not a mere minimum safety standard, but rather strike a balance between risks and benefits, and FDA’s regulations permit changes in labeling without prior approval only in narrow circumstances.”
Hat tip to Drug and Device Law blog
BP MD
This is so ridulous! Frequently, the FDA doesn’t know the whole story as drug companies try to hide or dismiss many safety issues. Sure, let them do whatever they want. If patients are harmed, it’s not their fault. W ewouldn’t want any of these poor, picked-on corporations to be held responsible for their actions! That’s expecting too much!
Dave Hamil
What’s the point of the FDA if not to set standards for safety and labelling?
Rose Golden
All too often products are approved by the FDA only to be taken off the market after too many injuries and deaths occur. It seems to me that the FDA is more concerned with the drug companies than any harm to consumers.However, allow any product to surface that is natural and effective and hear them howl. Could it be that natural products can not be prescribed and drug companies can not make obscene profits? By the way, fish oil which can be purchased in any health food store, can now be prescribed. It costs more because it is a prescription. Go figure! Colusion?
ol cranky
You guys need to review the case. This isn’t one where preemption is even relevant. This is actually a valid medical malpractice case since, like the Quaid case, the injury was caused by HCP errors.
Dr. Sal Giorgianni
I am cheering for the FDA position to prevail on this one. To essentially de-regulate Federal regulation of prescription drug labeling would insert cahos into the market. Those who advocate for this should remember that the pendulum of state, or municipality, mandated changes in information to consumers not only could chill access in some areas (tnink of the implications on prescriber liability in areas that have strong trial-lawyer lobbies) but also could could work in the opposite direction, more “liberal” labeling.
What happened to this woman is a tragedy but the proposed unraveling of a federally consistant and binding standard is not the solution.
Justice in Michigan
For Dr. Sal especially - No time to go over all the reasons here, but the “chaos” theory has never had any basis in fact. As you do know, until the Bush administration, FDA (though both Reps and Dems) itself asserted that the state tort system generally strengthened and complemented its own regulations.
The Wyeth case is not a strong one for the anti-preemption argument, which is partly why it was pushed by the Admin (via the Solicitor General) toward the Court to take on. But they are not just deciding on Wyeth, but on the issue of preemption.
One last bit - For Dr. Sal and others - please read the uncompromising editorials in NEJM against preemption. NEJM not part of the trial lawyer conspiracy. They describe preemption as policy that would have cataclysmic consequences for public health, patient rights, and industry accountability.
Last bit. There is no deregulation. No tort suit can determine what’s on a label; only FDA can. And companies are both free, and obliged, to change their label to note signficant new safety data without waiting for FDA approval.
So what would actually be deregulated by preemption would be the industry. There are many who have wanted that since the FDA first became into being. The preemptors are direct descendants (including financial base) of those who wanted to roll back Kefauver Harris that created the modern FDA after thalidomide.
That is really what supporting preemption means. First you gut the FDA. Then you canonize it. Result: No reg.
tm
lol are we supprised that the bush admimistration would stick there noses into this preemption case after all money to money,
hasen’t he done enought damage since hes been in office now this.
no recorce for the people whos lives have been devastated by the drug companys neglegence.all you preemptions supporters be careful it might come back to haunt you someday.
tm
im not supprised that the doctors support preempention after all i heard they get a big kickback for using there drugs.
its not about the victims they could care less its about the almight buck