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Shortly after the Senate passed its version of the FDA Revitalization Act (“FDARA”) last May, we sat down and read the whole thing – all 500 pages of it – looking for anything nefarious that might have been slipped into the legislation touching on preemption. We never blogged on the subject because we never found anything. Here’s a link to the Senate Bill itself, so you can check for yourselves if we missed anything. We don’t think we did.
That’s not to say that everything was copacetic. There’s a stain or two in the bill’s legislative history, but the bill itself came out clean. And our view of legislative history – especially in the absence of any affirmative language to support it – parallels that of Justice Scalia.
Anyway, happy reading.
Frankly, the Senate’s silence on preemption surprised us. Given the salience of preemption to what we do, and especially the attacks that plaintiffs have leveled on the FDA’s position on preemption-related issues, we were expecting something a lot worse than the vacuum we found – particularly since the FDA is part of a Republican administration and the Senate is controlled (albeit narrowly) by the Democrats.
We applaud the Senate for, on the whole, sticking to actual improvements in FDA procedures – rather than sticking it to our clients.
Now the other shoe has dropped. We aren’t lobbyists and have no direct knowledge at this time, but we saw a report today that the plaintiffs’ buddies in the House of Representatives are not contenting themselves with letting FDA-related preemption litigation take its course. According to the Medical Devices Today Blog (maintained by the Gray Sheet people), the early drafts of FDA legislation in the House contain a provision seeking to wipe out the express preemption the protects manufacturers of the most heavily regulated medical devices – those that are premarket (“PMA”) approved. Here’s the link. As far as we’re concerned, it’s hearsay, but in our experience the FDC folks almost always know what they’re talking about.
We’ve blogged on PMA preemption a number of times, here, here, and here, so this is something near and dear to our hearts.
It’s also a topic that doesn’t warrant another exegesis at this time. Right now, we just want to let our readers know ASAP that this threat has arisen so that they can organize themselves to combat it. When we have something more substantive to say, rest assured we’ll say it. For now:
To arms!