FDA Drug Chief Janet Woodcock Is A Change Agent?
8 CommentsBy Ed Silverman // March 18th, 2008 // 12:55 pm
In a rare out-of-character moment, the usually unflappable FDA commish Andy von Eschenbach bristled at a question during an appearance last week at the American Enterprise Institute. Apparently, he took umbrage at the suggestion that naming deputy commish Janet Woodcock to run the Center for Drug Evaluation and Research was simply an attempt to return the agency to its old ways, since she’s held that job before. After all, he did claim to conduct a national search.
“I do not see her going back to CDER as business as usual,” von Eschenbach shot back at a reporter, The In Vivo Blog writes. She “is going back as a very, very strong change agent, and we have mapped and discussed many of those changes that she is embarking upon.’ Just because she has a long tenure in FDA management and can be termed an ‘insider,” Andy sputtered, “does not in any way, shape or form mean that she is not a change agent.”
And then, Andy insisted “the CDER that Dr. Woodcock will create for tomorrow is nothing like the CDER that she left.” Why so sensitive all of the sudden? Could it be that FDA staff doesn’t understand why Andy didn’t bring in fresh blood after all the talk of doing things differently? Could it be that Andy is worried his moves are misunderstood by outsiders who see an unimaginative lame duck? Perhaps, In Vivo speculates, he is frustrated that others fail to see a chess game in which he opens up the deputy commish slot for a lasting choice that will secure his legacy. Oh, to be misunderstood.
Laurie
“Insanity: doing the same thing over and over again and expecting different results.”
Albert Einstein
Dr. Sal Giorgianni
This is a very interesting move. As we all know, the agenda for what can or can not be done at FDA is very much in the hands of the Commissioner and his agenda and temperament. If The Commish allows change and open minded dialog and change it will happen if it is status quo or hunker-down that is what happens. Dr. Woodcock is a very capable person who understands the dual mission of FDA and the political landscape very well and has proven herself over the long run. I think that with her experience and a mandate to be an agent of change from The Commish she is a splendid choice, particularly since she will be there after January 2009 and this agency will need a good deal of stability to continue on with its important work while the political meat grinder does its thing. The process needed to appoint a new FDA Commissioner is much more difficult and high-profile than it once was and as such a much prolonged process.
Just A Thought
Could it be that the consumers of Dilantin, now that Pfizer has quietly changed that drugs formula, are realizing health and financial devastation after the FDA allowed the drug company to distribute this changed medication and claim it is the same thing?
That there was a CRADA agreement between Pfizer and the FDA concerning this medication specifically?
That the patients were left to inform their doctors of this change, followed by Pfizer’s reps implying that the blame should be on the consumer by stating they should be having no trouble?
That John Theriault of Pfizer had the balls to address the House Committee of Energy and Commerce about counterfeit drugs just prior to them changing their own medication to something different, ineffective, and dangerous for many people?
That the FDA has completely ignored the adverse reaction reports of Pfizer’s Dilantin victims?
I don’t know. Just a thought.
Matt
Words… Show me the change and I’ll believe it…
RTW
Juat a Thought Well - Thats what happens when a company like Park-Davis is destroyed by the likes of big blue Pfizer. Guess the guys that took over the Dilantin plant couldn’t figure out how to formulate it anymore using the trade secrets from PD/Warner Lambert. Did the idiots loose the recipe?
Justice in Michigan
When Warner-Lambert handled it, there were more busts for manufacturing defects than in any drug’s history. Some were deliberately concealed from FDA, and WL got nailed on felony fraud criminal prosecution - extremely rare, as we know. Even Sid Wolfe (!) said he had never seen such a pattern of corrupt practice.
RTW
Yes - The plants in PR were a mess. Had a friend that went down to start doing audits after that mess. The managers there where out to lunch in lala land from what I understand. It was a culture of miss management and deceit at the facility. Mostly due to inept record keeping. Its more correct to say they where concealed from WL/PD upper management more than the FDA. After that QA moved back under the R&D organization again. Additionally you might note that there have been a lot of violations at just about any Pharma plant in PR, over a similar time period. Many Pharma have tried to divest themselves of those facilities.
Overall it probably cost WL a billion dolars, and the ability to develop a couple of very promising drugs due to lost resources. The projects where simply dropped due to a lack of money. Came back to them nearly 10 years later but by then it was too late.
Dr. Sal Giorgianni
OK this is all very interesting but…what does any of this have to do with the topic at issue…Dr. Woodcock and Leadership?