Life After Andy: Searching For FDA Leadership
15 CommentsBy Ed Silverman // November 6th, 2008 // 7:59 am
Who might succeed Andy von Eschenbach at the agency? This is fast becoming a favorite game now that the election is over. Last week, former FDA commish Mark McClellan demurred when asked whether Cleveland Clinic cardiologist and Barack Obama adviser Steve Nissen should be a likely choice (many pundits say he is, but our reader poll suggests otherwise; please see below).
Whoever is chosen has a tremendous task to accomplish, given repeated crises involving the food supply and drug safety, and the lack of consistent and assertive leadership. “What’s important is that the agency has credibility…that’s important not just for consumers but also for industry,” Joshua Sharfstein, who oversees the Baltimore Health Department and has been mentioned as a possible contender for the FDA’s top job, tells Reuters.
“The evolution of the agency and its role in society demands a more public, visible and transparent commissioner than we’ve had in a long time - not just in the Bush administration,” regulatory consultant Steven Grossman tells the news service.
The process may well take many months, but here are some of the potential candidates, in no particular order, according to The In Vivo Report. Besides Nissen, there’s Bruce Psaty, the University of Washington academic who has a made name for himself as a drug-safety expert. Duke University’s Robert Califf, who chairs the Critical Path Initiative.
A dark horse may be Mary Pendergast, a consultant who was a former associate FDA commish under David Kessler; another high profile name is David Blumenthal, a Harvard Med School professor and director of Massachusetts General Hospital’s Institute for Health Policy, who was also a big contributor to the Obama health plan; and an outside shot could be Susan Wood, the former head of women’s health at FDA, who resigned in protest after the delay in switching the morning-after pill over-the-counter. She now represents the Union of Concerned Scientists in a public capacity and is a research professor at the George Washington University for Public Policy.
Justice in MI
I had been wondering about Psaty - less provocative choice than Nissen, I think.
Josh
I think this needs discussion. No ties to the industry? What about those quality professionals with FDA regulations experience / education and have put their job(s) at risk for standing to enforce and follow FDA expectations? Seems counterintuitive. I understand the intent completely, believe me … but that approach will automatically count out many that probably SHOULD be there. I am a scientist also, but having the experience with the regulations and their application is priceless. I know people who are scientists in academic settings, and they are very bright and able people. I wouldn’t feel too comfortable with them understanding and enforcing regulations without years of industry experience…
J
Justice in MI
Josh - I agree with you. I don’t think there should be a “litmus test.” What counts is a proven record of integrity and relevant expertise.
Philip Rudnick
“Critical Path Initiative”? This is simply a BigPharma-FDA swindle in Madison Avenue garb to accelerate even faster the approval of drugs with a minimum of prior safety testing. It’s the very opposite of what current continual drug safety disasters require.
An FDA Reviewer
Has anyone else noticed that all of these individuals have experience with cardiovascular toxicity of drugs? Maybe there’s a reason.
An FDA Reviewer
The WSJ blog indicated Janet Woodcock the current CDER Director would really make Pharma happy.
A number of FDA reviewers I’ve know have said that they believe she deserves to be put in jail.
Josh
Reviewer - no, I didn’t know that. Why do you think that may be?
J
Josh
We will hasten the approval of drugs as more companies use newer technologies available to minmize cost and time to market.
J
Nathan
An FDA Reviewer,
Do you ever have anything positive to say about your work? It seems that you just like to air your dirty laudry out here in the open where people are happy to read about it. But it’s seeming more and more likely to me that you are just a disgruntled employee who hates what you do for a living.
David
Nathan -
So airing dirty laundry with the hope it might precipitate some change is inappropriate in your eyes?
IMO that is why this industry is in the shape it is - because too many people have been willing to look the other way for too long.
Nathan
Dan, no - it’s perfectly appropriate. However, the AMOUNT of dirty laundry is what is strange to me. I don’t see any “hope it might precipitiate some change” — I only see complaints - not constructive critisism or suggestions - only complaints.
Maybe I’m totally off-base, but this seems to be a voice of a disgruntled long-time employee frustrated with his/her job but afraid to do something contructive about it.
An FDA Reviewer
Thank you David.
Nathan,
I love my work and do it ethically.
Would your say the same thing to someone who worked on the plans for Auschwitz, realized what was really going on, and tried to warn the Jews?
From what I have seen I believe that I am in a similar position. However information on drugs are trade secrets and besides the press isn’t going to listen.
Unfortunately our government has virtually killed free speech and unless a Congressman or Senator releases information those of us who work in government will be fired, go to jail, and even face the possibility of having ourselves or our family members killed as retaliation for actually speaking out and warning people.
Why do you say anything now when I simply make a statement about what other reviewers have said to me?
Personally I agree with them. I have seen Janet Woodcock do something that I believe actually is criminal. The problem comes down to proving it. I could testify as to what I observed but I simply don’t trust that others who observed the same thing to speak the truth.
I don’t hate. Instead I have hope. I have hope that maybe, just maybe, that I can help not prevent but minimize another tragedy like Vioxx that is actually occurring right now as I write this.
David
Nathan -
What would you suggest FDA Reviewer do? I am certain he would be interested in any ideas you might have.
Nathan
Reviewer,
1) If someone was working on the plans for Auschwitz I hope that they would quit their job and testify to what they saw/heard.
2) In your postings, you seem to forget that we ALL want safe drugs to be approved - even those of us in pharma and (almost certainly) those in the management of the FDA. There are differences of opinions about how to achieve that goal. I hear complaints from you frequently, but I seldom (if ever) have heard a viable suggestion on how the present system could be FIXED. (short of firing all your bosses)
Do you genuinely believe that those in the management of the FDA wish harm upon people just to pad their pocketbooks? It’s not even clear to me why they would have any pressure to approve drugs at all. What kind of pressure can pharma really apply to the FDA? It’s not as if the FDA (or its managment) gets a cut of drug profits. Yet that’s the impression you constantly give.
An FDA Reviewer
Nathan,
If I could quit my job and speak I would. However even if I quit my job I still couldn’t speak legally.
As for suggestions. There are those in Congress that know what needs to be done. They need the politicaly clout from the public that writes them so they can actually do something.
I’m not going to get into specifics of what pressures and rewards FDA management can bring. The more I reveal the more likely FDA management will be able to find something I say so they can use it against me.
An FDA Reviewer