The FDA has finalized the new CBE rule. (That’s the so-called “Change Being Effected” rule at 21 C.F.R. Sec. 314.70(c)(6) for drugs.)
Here was our post on that subject when the FDA proposed the rule in January. (We explain there why this change is a big deal.)
A confession: There wasn’t supposed to be a Part II to this post.
When we posted our earlier users guide to the Levine defense amicus briefs, we thought we had included everything – we really did.
Shows what we know.
It seems our “good ol’ boys” approach to collecting the defense amicus briefs had a
We posted Wyeth’s principal brief in Wyeth v. Levine as soon as we got it to ensure our readers’ “first on the web” priority (much like we did with today’s Vioxx decisions). That was a “sight unseen” post, something we don’t generally like doing. We’d much rather give you our take on things – we
We’ve had an unusual number of plaintiffs’ side blogs link to our Riegel posts over the past several days. While we’re flattered that the other side thinks we’re worth noticing, the traffic from these links has produced quite a few comments trashing either the Supreme Court (especially Justice Scalia), the FDA, or both. We’ve returned
We told you when we posted about it last week (here and here) that the FDA’s new proposed CBE regulation would create a firestorm.
The organization formerly known as ATLA was the first to react, but the Democrats in Congress were not far behind.
Today’s Star-Ledger reported on a letter several leading Democrats
The Wyeth v. Levine case is such a big deal that you can bet we’ll be discussing it a lot. For one thing, it has the potential to obliterate entire mass tort litigations at a stroke. Since we’re mass tort kind of guys, we’re keeping a mental hit list of where we’d strike first after
The other day we got a tip that the FDA had just posted something on its website that we’d want to read. Even though we were both swamped (Herrmann was preparing for yet another trial, and Bexis had two appellate briefs to finish, including one about “the largest class certified in history” – the court’s
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
Implied preemption in prescription drug cases basically comes down to how a judge feels about whether a manufacturer can unilaterally change its label to “strengthen” warnings under 21 C.F.R. §314.70(c) – the so-called “Changes Being Effected” (CBE) regulation. Our side claims that the CBE regulation doesn’t change anything fundamentally, because the FDA still has to
When you argue implied preemption as much as we do in prescription drug product liability litigation cases, you get to know the plaintiffs’ come back arguments in your sleep. Chief among them is that because the FDA’s so-called “changes being effected” (“CBE”) regulation, 21 C.F.R. §314.70(c), allows drug manufacturers to strengthen safety language without prior