FOREPLAY

Andrew Von E Joins Regulatory Consulting Firm

Wow, it just keeps on coming. Thanks to our loyal and intrepid participant Nancy Fruge, we learn that former FDA Commish AVE is already making his services available to a regulatory consulting firm. The link is essentially a puff piece, but it does convey the news.

http://www.centredaily.com/business/technology/story/1138527.html

This quick a move from FDA to industry consulting should probably lay to rest the notion of a "revolving door." Doors don't revolve that fast. Instead, perhaps we should just consider senior FDA positions a kind of lube job.

Lilly the FDA and Intellectual Bias

Here's an interesting article in the blog - Hooked: Ethics, Medicine, and Pharma 

called - Lilly Says Jump, FDA Says How High--More on "Intellectual Bias" 

by Dr. Howard Brody

The article is very much in line with what some of our regular friends on PharmaLittle have been telling us of the inner workings of the FDA. In this case they got caught. 

PFIZER V. GRASSLEY

Disclosing Gifts to Docs

The WSJ Health blog has an interesting commentary on the difference between some of the plans for disclosure of gifts to docs put forward by companies and the plan advocated by Chuck Grassley.

http://blogs.wsj.com/health/2009/02/10/how-pfizers-doctor-payment-disclosure-compares-to-grassley-plan/

Some of the commenters point out that none of this would impact patients; they would not change docs or question a particular prescription.

I wonder if that is true. I'm not talking about the small sums, but if you knew your doc was receiving very significant moolah from this or that company, would it impact the way you viewed that practice and impact your experience and even choices as a patient?

Will Chief Justice Roberts Recuse in Wyeth v. Levine?

Is Roberts Recusal Possible?

Anne PME, one of our crack field reporters, raises the above question, linked to a post that can be found at:

http://legaltimes.typepad.com/blt/2009/02/should-cj-roberts-recuse-in-landmark-wyeth-case.html

(But if you don't want to link, the whole post is in our "drop box" thread. Just don't tell anybody.)

The logic would be that, now that Pfizer and Wyeth are to be wed (or at least become domestic partners), would Roberts' holding of stock in Pfizer lead to his deciding to recuse in the Levine case. Some of you will recall he did so in Warner-Lambert v. Kent (Warner-Lambert, of course, now being part of Pfizer) leading to a 4-4 non-decision. Most folks believe that, had Roberts voted, it would have been on the side of WL, and thus have given the company a 5-4 victory. The Kent case concerned our own (not beloved by all) Michigan law which, on paper, has a "fraud exception" for preemption. WL claimed, however, that that exception was itself preempted, since--based on the Buckman precedent--only the FDA can find fraud against itself. (Even though it essentially never does in such contexts.) And, argued the FDA/DOJ in Kent, even if FDA _did_ find fraud, that should not open the door to private lawsuits.

Confused? The short lesson here is that, according to the FDA/DOJ, there are NO conditions--including FDA's finding that a company committed felony fraud in the pre- or post-approval processl--that would allow lawsuits against that or any other company. None. Nada. Zilch. That's broad preemption, folks. And that's why DDL and others are clear about their goal of prescription drug litigation "vanishing from the face of the earth" (DDL, 11/6/08). And next time you hear preemptors tell us differently--and preemptors try to tell us differently almost every day--don't believe them.

In any event, I think it extremely unlikely Justice Roberts will recuse. As the article points out, a simple strategy would be simply to sell his Pfizer stock. Given the importance of Levine, that would seem his most likely course of action. It might also be argued that the new company--Pfyzeth--would not be the same as Pfizer. And/or that it will not exist until after a decision in Levine anyway.

Whatever. I say he sells the stock.