As most of our regular readers no doubt already know, not quite two weeks ago, we had to flip one of the cases in our Drug Preemption Scorecard. Specifically, the pro-preemption decision Tucker v. SmithKline Beecham Corp., 2007 WL 2726259 (S.D. Ind. Sept. 19, 2007) (“Tucker I”), became the anti-preemption decision,
The other day the FDA proposed a rule to revise those aspects of drug labeling dealing with pregnancy and childbirth. The FDA Law Blog has a good description of the proposed changes. The FDA proposal itself is at 73 Fed. Reg. 30831 (FDA May 29, 2008). We were, however, most interested in whether the proposed
Late last week, the FDA filed a short post-argument submission with the Third Circuit in Colacicco, which the parties recently received. Here’s a copy. It’s only a couple of pages. The submission has three purposes: (1) It provides the court with a copy of the brief that the agency recently filed with the
The FDA posted on its website today a regulatory initiative that will affect many prescription drug/implied preemption arguments. It’s an agency’s proposal to change amend its “Changes Being Effected” regulations for drugs, devices and biologics rule to restrict the ability of manufacturers to make label changes that add/strengthen warnings prior to FDA approval.
We’re both
The Solicitor General has finally filed its long-awaited brief recommending whether the Supreme Court should grant certiorari in Wyeth v. Levine, which we previously described as the most important of the preemption trilogy that the Court may hear this Term.
We have just three things to say:
Ho, ho, and ho!
Unfortunately, we can’t yet
We must have been a little asleep at the switch, because, several weeks ago, now, the Solicitor General, on behalf of the FDA, filed the government’s merits amicus brief in the Riegel v. Medtronic PMA express preemption case. We didn’t find out about it (and none of you told us – hey, we can whine
The Solicitor General, on behalf of the FDA, has recently filed amicus briefs in both the Riegel v. Medtronic and Warner-Lambert v. Kent (formerly Desiano) Supreme Court preemption cases. We’re doing a separate post on Riegel, but we did this one first because it’s more in the nature of “breaking news” – it
Here’s the SG’s amicus brief in Riegel v. Medtronic, as it appears on the SG’s website. We’ll give you more analysis tomorrow, but take our word for it, if you like preemption like we do, it’s gooooooood.
The SG recently filed a pro-preemption amicus brief in Riegel v. Medtronic. We’ve read it, and it’s very nice – and useful in the drug field as well. However, our copy is missing a couple of pages at the front and back, so we’re still looking for a complete copy to post.
Also, the
More preemption inside baseball this post. If you’re not a preemption wonk like us, try again tomorrow. If you are, you’ll get a present today. We got exercised and went out and did some original research.
We started this post out thinking mostly about Executive Order 13132. Why an eight year old executive order,