Yesterday Washington DC was an amazing place. Nine out of ten voters had voted for Barack Obama. Everyone was walking around the city with a sort of goofy and dazed expression, myself included. I have never had so many people just spontaneously start up a conversation with me on the street, standing at the corner, waiting for the car in the parking garage, standing in line for lunch. It was an amazing day.
The haze will lift quickly – times demand it. Today’s New York Times runs the headline For Obama, No Day to Bask as He Starts to Build His Team for Transition . Indeed, already staff and cabinet appointment speculation has started.
For the FDA, speculation on who will fill the spot has already started. There is no question of Dr. von Eschenbach staying. He’s going to be out. It is less interesting who the person is over what he or she can bring to the table in terms of a unique mix of strengths, because there is a long list of needs on the part of the agency – an agency that has experienced a virtual vacuum of leadership for nearly the entire Bush presidency occurring exactly at a time when the agency was experiencing unprecedented challenge in overseeing the regulation of one-quarter of the nation’s economy.
Is it possible to find someone with the following qualifications?
- Have a solid grasp of the pharmaceutical industry without being associated with it – the HELP Committee of the Senate may insist that the individual have no ties with the pharmaceutical industry itself – so a person who knows research, but hasn’t done any? That may be a tall bill to follow. In any case, the person has to have a good understanding of clinical research and public health. And the Senate will likely put a premium on someone whose industry contacts are de minimis.
- Can balance the policy maker hunger for safety while assuring that the pipeline produces. The public appetite is extremely risk averse. At the same time, new approvals are slowing. Heck, PDUFA fees drive the FDA budget at this point. It is in everyone’s best interests, particularly at a time when there could be many landscape shifting medical discoveries in the coming years, that the public be assured of safety without hobbling the drive to bring new medicines to fruition.
- Can have the credibility and gravitas to tell policy makers on the Hill to stop using the agency as a political means to gain headlines and bash. Remind them gently that it is a new Administration and there is one-party rule and most of them are in that one party.
- Be an incredible visionary and communicator. The agency is in trouble not only from a functional point of view, but has done very little to proactively address the descent of its image and to communicate and assure the public and policy makers that there is a vision. In fact, the agency does not seem to acknowledge much of a problem, much less a plan for solving it. The new commissioner needs to understand this, act upon it, and seize leadership. Pronto. And goodness knows, he or she cannot hire a public relations agency to help!
For those who are driven on the "who" part of this search, the person who has advised President Obama on a number of health issues is Dora Hughes, who used to work for HELP. If you can guess who she would choose, you may just be the winner.
Republished to correct typo after initial pub.
While there are a number of excellent potential candidates to replace von E, one that should be considered in my humble opinion is Peter Barton Hutt.
Peter Barton Hutt, former counsel for the FDA and regulatory law expert from Harvard
University wrote an article years ago that laid out some basic principles for sound
government regulatory policy.
1. To protect the public from harm.
2. To preserve maximum individual freedom of choice.
3. To guarantee meaningful public participation in the decision making process.
4. To promote consistent and dependable rules that are equally applicable to everyone.
5. To provide prompt decisions on all of the issues that arise in a regulatory context.
I don’t agree.
Peter Barton Hutt knows a lot about FDA, but has openly supported premption. Not only the principle, but how it was executed within FDA (which, by the way, did not involve meaningful public participation in the decision making process.
It is healthy to have smart people disagreeing on important topics…but he would not be a good person to run FDA right now. It needs to be rebuilt by “public health” types. Also, to the extent the agency will have more money to spend…the new people in charge will have to be able to spend it wisely. Someone who knows how to run a bureaucracy.
Nothing has changed except that we have increased the FDAs budget by 50% in the last two years. Still they are more risk adverse then ever and driving innovative companies to foriegn governments. You will see an end to the PDUFA payments and funding of the FDA if they dont start rebalancing that risk to benefit ratio and I mean NOW!