DAN TROY'S LAST PUFF

THE FALL OF THE HOUSE THAT TROY BUILT


As many here know, former FDA Chief Counsel Dan Troy earned his stripes in his successful efforts on the part of Brown & Williamson to block FDA regulation of tobacco during the Clinton years. That effort, and other deregulatory struggles against FDA especially regarding off-label promotion, made him the perfect candidate for FDA's top lawyer--and close to de facto Commissioner--during the first four years of Bush II. He is now Chief Counsel and #2 of Glaxo.

Given the FDA's successful bid to regulate tobacco, much to the house that Troy built has now been successfully dismantled. His arguments in favor of preemption were dismissed as essentially irrelevant by both sides in Wyeth v. Levine. With the regulation of tobacco, another piece of the Troy legacy goes into the dustbin.

Of course, one should never underestimate the persistence of those who fight for the agenda that Troy championed, and almost certainly still champions, from inside the walls of Glaxo. The Washington Legal Foundation and other hard-right "think tanks" have not given up their aims. They are only a bit more quiet about it at the moment.

The take-over that the hard-right engineered that culminated in the Bush years was a long time in the making. They are patient people. And they continue to sit on more money, as Philip Morris once put it, "than God."

OBAMA ON PREEMPTION

Memo on Overall Policy

In what I believe is the first general policy statement on federal agency preemption, the Obama administration directly rejects what had been the pattern of the past eight years. In particular, note is made of agency preambles which insert preemption language (or presumption) without basis in statutory law. The Troy-era FDA "preemption preamble" will be the most obvious example to people here.

The UPI story on the policy memo is here:

http://www.upi.com/Top_News/2009/05/20/Obama-issues-memo-on-pre-emption-regs/UPI-19211242855063/

In some respects, the Troy-era position was already dissolved. In Wyeth v. Levine, even the dissent paid essentially no attention to it. The majority blew it aside as irrelevant.

Editorial opinion: ding, dong the witch is dead.

WE WON!

David Vladeck to FTC

When Dan Troy left his role as FDA Chief Counsel in 2004, he had only a few comments to the press. One was his reflection, "We won," referring the the 2004 Bush reelection and perhaps more.

Troy continued to impact matters FDA and the superstructure of rule-making--the 2006 preamble, the CBE changes, etc.--all of which were to be part of the yellow brick road to preemption.

Of course, as it turned out, the road was a house of cards. It was whisked away as "meritless" in the Levine majority and essentially ignored in the dissent. It turned out that nothing was won after all, at least not on that front.

So, with relevant perspective, we can celebrate a bit here after learning of the appointment of David Vladeck to FTC. (Hat tip to Pharmalot in exile and various links along the line). Most here will know Vladeck through his writings against preemption that, it turns out, were cited at significant points in the majority opinion in Levine.

So there are still battles to fight: Device preemption as represented by the Riegel decision; Michigan's odious shield law which is on another legal planet even relative to the dissent in Levine. But there should always be a moment when we can kick back, check in on a link,

http://www.democraticmedia.org/jcblog/?p=791

open a brewsky, and say--with relevant satisfaction--"We won."

And they didn't.

PHARMA, TOBACCO, AND THE FDA

Smoking in Bed



As many will know, Congress passed a bill today that would enable the FDA to regulate tobacco for the first time. The New York Times has the story at:


http://www.nytimes.com/2009/04/03/us/politics/03tobacco.html?emc=tnt&tntemail0=y


What is of wider interest here are the political alliances between the tobacco and pharmaceutical industries in recent years, as profoundly different have been their contributions to the public good. Still, their champions--especially regarding limiting regulation and liability--have been many of the same people and organizations. Likewise, the two industries joined in funding the "think tanks" that fostered the ideologies of deregulation and preemption that have been so prominent a part of contemporary policy debates.



Dan Troy is, of course, the most famous. A year before he became FDA Chief Counsel, he successfully argued in the Supreme Court against FDA regulation of tobacco. That is the legacy which Congress is now working to reverse.



The Washington Legal Foundation, which took point in the deregulatory movement in the mid-90s, was also a shared creation of tobacco, pharma, and hard right family foundations. During the '90s, for example, when Republicans under Gingrich worked to disssolve the post-thalidomide FDA (Kefauver-Harris amendments), the WLF published a series of full-page ads in the Wall Street Journal and elsewhere, trumpeting what was described as the near genocidal impact of FDA regulation. More recently, the WLF is known for its fight against regulation of off-label promotion. Indeed, Wiley Rein--the same firm that represented Wyeth in the Levine preemption case--was centrally responsible for the "liberalizing" of off-label drug promotion in a 2000 case (http://www.wileyrein.com/news_release.cfm?press_release_id=2173) The links between the WLF and both pharma and tobacco (especially tobacco) are summarized at http://www.sourcewatch.org/index.php?title=Washington_Legal_Foundation


Many believe that the rage against FDA in the '90s, and against Commssioner David Kessler in particular, was fueled above all by Kessler's attempts then to regulate tobacco.


Today, many in pharma are shocked by the fact that public opinion polls rank the industry close to big tobacco in overall approval ratings. In my view, that shock is well-founded. But the connection has a specific political history of shared alliances and agenda. It does not emerge from nowhere.