Glaxo Hires Former FDA Chief Counsel Dan Troy
17 CommentsBy Ed Silverman // July 22nd, 2008 // 4:19 pm
The preemption prince is joining the big drugmaker as senior vice president and general counsel on September 2. This is a coup for Glaxo, because Troy is widely known - some might say notorious - for being supportive of the pharmaceutical industry (see here).
During his tenure as FDA chief counsel, Troy instructed agency staff to issue fewer warning letters in the belief that the missives were being ignored, which critics say led to less effective enforcement of advertising violations. He also laid the groundwork for the current legal battle over preemption, which says FDA approval supercedes state law claims challenging safety, efficacy, or labeling. Drugmakers and the FDA argue preemption exists by maintaining agency actions are the final word on safety and effectiveness.
A case goes before the US Supreme Court this fall and the ruling could determine whether patients can sue a drugmaker through state law when a product has already been approved by the FDA. Coincidentally, a US District Court Judge in Indiana last week reversed his prior opinion in which he had dismissed a Paxil suicide case based on preemption.
This also comes as a Justice Department investigation of Glaxo’s handling of its Paxil antidepressant is widening. You may recall the drugmaker last month confirmed that a previously disclosed Justice Department investigation of marketing practices, which was based in Colorado, now includes the US Attorney’s office in Boston and is being coordinated by the agency in Washington.
This followed a demand by Chuck Grassley, the ranking Republican on the Senate Finance Committee, for an FDA investigation. More recently, the same committee began probing Martin Keller, a Brown University psychiatrist, for his role in studying Glaxo’s Paxil antidepressant. The committee, according to sources familiar with the investigation, sent a letter last month.
Currently, Troy is a partner at the Sidley Austin law firm in Washington, DC, where he represents drugmakers and trade groups on issues concerning the FDA and government regulations.
“Dan shares our vision that it is critical in today’s healthcare environment that we deliver differentiated products of real value to patients and payors. His wealth of experience in the regulatory legislative area will be of enormous benefit to us, and ultimately to patients,” says Glaxo ceo Andrew Witty, in a statement.
Dan
The revolving door syndrome continues.
Justice in MI
Holy cow …
DT (who is personally a nice guy) is, indeed, is to preemption what James Brown is to soul.
Ed writes: “He also laid the groundwork for the current legal battle over preemption, which says FDA approval supercedes state law claims challenging safety, efficacy, or labeling. Drugmakers and the FDA argue preemption exists by maintaining agency actions are the final word on safety and effectiveness.”
Just in case it isn’t clear: Those of us who oppose preemption do not in the least challenge FDA’s authority over all regulatory matters, including the label.
As NEJM and many others have noted - including FDA until the recent era - the civil justice system and FDA have been complementary, not contesting, in most instances. And FDA approval/compliance has always played a key role in a company’s defense, as well it should.
The only question has been whether FDA approval/compliance is the _only_ relevant criterion when considering potential liability. There one needs to think about what approval/compliance really mean in practice, and what can be done by determined actors behind that door.
Examples of what can be done were detailed in a recent thread.
Justinian Lane
Wouldn’t it be nice if there was some sort of a one or two year window before former FDA employees can join pharma? It would go a long way to preventing the appearance of a quid pro quo…
Justice in MI
Agree with you in principle, Justinian. DT left FDA in November, 2004 (for private law practice) so he personally would be in well out of the window.
Insider
A good and faithful servant.
Laurie
Wow..GSK takes on the one person who has been the poster boy for all that’s bad with pharma and the FDA…way to help your public relations. No surprise here….DT has been pharma’s golden child, especially when Chief Counsel for the FDA. His “interests” were always pharma’s interests.
big bad wolf
Dont think for one moment that Roche in Basal wasnt thinking cost reduction and pipeline injection. People will be laid off. No way they are keeping all these people. Unfortantly DNA was hiring the top people for the last 10 years. DNA people for the most part will be safe. However HR will have to get rid of some to make it look all neat and pretty. Higher the pay the quicker your on the chopping block. George E. even knows his day is coming. A different world we live in today compared to 10 years ago. But wait, this merger will not be the last. I expect amgen will do something soon. They dont have much in the pipeline. They are expecting DMAb to be all that, However generics, competition and managed care will tame all their expectations. Also, patent issues coming right around the corner. How about this dream. Novartis bids for amgen, novartis has large stake in Roche. Then Novartis, amgen, roche, and genetech all become one company. Talk about domination!!! New company name…. ONE BIG BAD ASS! or NOVMART. you take your pick
Phed-Up
“Dan shares our vision…”
That about sums it up (and not in a positive way). GSK is sinking into an amoral pit.
truthman30
” GSK is sinking into an amoral pit” …
Correction..
GSK has been slithering at the bottom of an amoral pit for quite some time…
Thom
It could only get better if GSK would hire Scott Gottlieb and VP of Communications. Then they would surely become the lowest of the low.
BOB FIDDAMAN
I think it’s a case of ‘You scratch our back and we will scratch yours’
Read into that what you will!
Fid
harpy
Even if there were some sort of delay window, there would be a way around it. One need only look at the example of Billy Tauzin and PhRMA.
Justice in MI
The door from Congress to industry is pretty much straight through - not even time to revolve. Zillions of examples at all levels, as you know.
The door from industry to government is slightly more narrow. DT had to wait roughly a year between his work for pharma and big tobacco clients and his job as their “regulator.”
LILLI
J. Lane
You are correct, the same should be with a retireded Congressman. In fact depending upon the connections, maybe never.
Farmed Out
This just proves you can’t keep a bad man down. There are a couple of other FDA “stars” who could join Glaxo - where they would probably do less damage.
Henri
Let’s not forget Dan’s brother Tevi. He’s now Deputy Secretary of HHS in charge of the Centers for Medicare and Medicaid Services (CMS).
They’re the ones who help pay for all those expensive new drugs as well as the treatments for the side effects they cause (like the cardiac problems due to Vioxx) and the brain damaged kids whose mothers take Lamictal (another Glaxo wonder drug) during pregnancy and the kids who get Stevens Johnson’s Syndrome from it.
Also remember all the recent congressional hearings on how we Medicaid is going to break the federal budget eventually.
By the way has anyone else noticed that the ex-Glaxo VP for pediatric marketing strategy who was hired while Lamictal was under review was then hired to head up FDA’s new Pediatric Division and the ex-Glaxo VP responsible for automating their data analysis (think coding problems) also has been involved in setting up the data analysis systems at FDA.
If you think I’m joking take a look at Rep. Rosa DeLauro’s letter to Von Eschenbach from last November.
truthman30
Do the FDA and Pharma nor get very dizzy with all those revolving doors?