Word has it that Acting FDA Commissioner Andrew C. von Eschenbach, M.D. (appointed in September 2005) is about to drop the acting part of his title and assume full leadership of the agency.
He has little shoes to fill. The last person who held the title stayed in it 3 months, not helping the agency’s beleaguered image.
But, if he does, in fact, assume the job, he has his work cut out for him. The FDA was once considered a gold standard agency. But, it has been without strong, consistent leadership for many seasons resulting in a series of circumstances that have tarnished that golden image.
- Sluggish moves to ban ephedra
- Movements on warning labels for anti-depressants that appeared to some, glacial
- The COX-2 recall
- The flu vaccine mess where British medical authorities shut down an American manufacturer without FDA’s foreknowledge
- The on-going Plan B debacle where the agency decided to shoot its credibility in the foot
- A series of congressional hearings that delivered several very public black eyes
- A survey that revealed that most agency employees don’t believe that the agency is adequately protecting public health
It may not sound like it, but I am a big fan of the FDA. I do believe they protect public health and I do believe they do a good job on the science side. They are not doing such a good job on the public image side – nor, in fact, is the pharmaceutical industry, of which I am also a fan. But in both cases, a fan who is not also a constructive critic is not of much use.
In the coming days, I will use often this space to talk about some of the ways the appointment process will impact manufacturers and the image of the pharmaceutical industry.
Plan B: Grade F
I agree with you completely that the FDA is in serious trouble these days.
While the real losers here are the women denied easy access to Plan B, holding up von Eschenbach’s confirmation brings no prizes for the rest of us either. The FDA is charged with evaluating, regulating, and monitoring the safety and efficacy of the substances that we put into our bodies. While Bush bickers with senators in Washington, the FDA is left languishing under a culture that allows politics to inform scientific decisions about health and safety, and that lacks a confirmed commissioner who is capable and willing to bring change to the administration.
As the Plan B dispute continues to drag on, the only thing that’s clear is that both the politicians and the food and drug administration deserve a failing grade for their handling of this situation.