Monday, November 10, 2008
The Washington Post has an AP story that the incoming administration intends to reverse by executive order dozens of Bush administration actions, ranging from stem cell research to climate change-related actions. Not mentioned are the many regulatory agency efforts to increase the preemptive effect of regulatory actions by the FDA and other federal agencies; the administration might, I suppose, be waiting the outcome of Levine. The NYT has a similar story, again not mentioning products stuff specifically. Update: I wrote this too quickly, and only referenced executive order actions. The coverage more generally (including the NYT piece) is not limited to executive order actions, and I didn't intend to focus exclusively on executive orders. The issue is more about early action by the administrative, whether through executive order, regulatory action, or legislation. Thanks to Mark Herrmann for pointing out my vagueness.
As an aside, given the likely legislative response if the Supreme Court does find for Wyeth: I did a piece in the now-gone Minnesota Intellectual Property Review when I first came on the market that suggested that FDA determinations be given roughly the same deference as the PTO -- i.e., that a jury be directed to presume that the decision is correct and that to find counter to the decision would require clear and convincing evidence. (This is, if memory serves, similar to a state-created structure in...Texas? I don't remember where offhand, and my reprints are in my office while I'm at home.)
Perhaps something along those lines could be a semi-middle-ground, giving some protection but not outright preemption?