Wyeth To Supremes: Waxman Carries ‘No Weight’
5 CommentsBy Ed Silverman // October 31st, 2008 // 12:37 pm
The drugmaker this morning hand-delivered a letter to the Supreme Court responding to the report released two days ago by the House Committee on Oversight and Government Reform, which is chaired by California Democrat Henry Waxman (back story). And Wyeth, essentially, tells the court that the report should be dismissed, citing these reasons…
First, the report is entitled to no ‘persuasive weight,’ because it was written only by the majority committee staff and was not adopted by any full committee. Next, the report actually supports Wyeth’s position about the meaning of the ‘change being effected,’ or CBE labeling regulation, which restricts the ability of drugmakers to disclose new safety risks without prior FDA approval. And finally, Wyeth asserts the report selectively quotes at least one e-mail from John Jenkins, who heads the Office of New Drugs at the FDA’s Center for Drug Evaluation and Research. (You can read it here).
Hat tip to Drug & Device Law blog
Facts
Of course Wyeth thinks he has no weight. They don’t want the Supreme Court to pay any attention at all to him. It could affect their chances of coming out on top. Although the case under review is a very tough one by itself, there are others that are not.
Jim
It’s funny because the other day when I first read the Waxman report on this Blog I was going to ask the question as to how much weight that this report was likely to hold with the Court.
It appears that Wyeth has answered my question; apparently they felt that the report may influence the decision of the Court. However after reading Scalia’s opinion in Riegel v Medtronics where he pretty much telegraphs his decision for Wyeth I doubt very much that the Waxman Report will carry any weight at all with Justice Scalia or any other member of the Conservative Pro-Business Majority.
Wyeth could have saved themselves the cost of a messenger.
Justice in Mi
I agree with Jim - it suggests how scared the preemptors are that they think this would have the impact they fear. The real impact would not be from this or that single report, but the much greater number of industry and FDA folks who will be talking much more about how approval/compliance really works. We’ve heard from some of them here.
Someone
If the US wants to see themselves in another civil state of war, then they should find in favor of Wyeth. No, I think it is time that the people of the united States win one for the Union of the United States.
The only way for there to be any semblance of balance is to vote with the people on this matter, Wyeth must lose.
Justice must prevail, final!
Anne PME
Why do career FDA employees have to sneak around and risk their jobs to ensure that their professional judgement/viewpoint is noted on the record? Isn’t it their job to provide their professional viewpoint - isn’t that what my tax dollars are paying them to do?
The Supremes need and should have the right to access and question medical professionals who have current clinical experience and FDA career personnel, especially given that they are the ones who will ultimately be forced to deal day to day with the long term implications of this ruling.
Perhaps Wyeth should put a disclaimer on all of their inserts that reads: Warning to all of the patients who pay our salary (i.e. customers: if you complain or if you, your doctor or your pharmacist file a Medwatch report about a Wyeth drug or have the audacity to take a drug that we do not own the rights to, we will turn your life upside down; make you spend years of your life dealing with trial lawyers and litigation; and drag you, your doctor, pharmacist and family through the mud until you beg us for mercy (or another dose of a billable Wyeth drug).