Dr. Andrew von Eschenbach stepped down as the head of the Food and Drug Administration in 2009, but he doesn’t think his work with the agency is done. Eschenbach, who now heads Project FDA at the conservative Manhattan Institute, says that efforts in Congress to push for changes through the Prescription Drug User Fee Act, under which drug companies pick up a big chunk of the tab for FDA reviews, aren’t enough. Without a structural overhaul, he says, the regulator is on the verge of “catastrophic failure.” Edited excerpts from his conversation with National Journal follow.
NJ What’s wrong with the FDA?
Von Eschenbach One has to step back from the problem and appreciate how really big it is. It’s a huge challenge. For decades, this agency has been under-resourced and has had very little attention paid to it in terms of [keeping] pace with all of its challenges. The question we have to ask is, what is it that we have to do—what are the structural and functional changes that you might have to address if you’re going to create the FDA of the 21st century?
NJ What’s one example of change that the FDA needs?
Von Eschenbach First and foremost, it is a resource problem, but it’s not simply a resource problem. If you look at it from the macro point of view, you start to see structural problems. For example, at the [National Cancer Institute, which von Eschenbach ran for four years], I had a National Cancer Advisory Board, a board of scientific counselors. I had ample access to, and ample opportunities to be able to get input from, outside experts in terms of the future strategic direction NCI should be taking. None of that exists at the FDA. We could create a board of directors—create something akin to the National Cancer Advisory Board—on an ongoing, regular, consistent basis with expertise and knowledge to provide advice and oversight on behalf of the administration and the American people. That’s just one of many changes.
“If we were to wait until 2017 to make these changes, we will be in catastrophic failure by then.”
NJ Can Congress make any of the changes this year?
Von Eschenbach The problem is that Congress reauthorizes these user fees every five years. That sort of became the formula, that every five years Congress takes a look at the FDA because it has to. I was there in 2007, and we went through this process, and now here we are in 2012. If we were to wait until 2017 to make these changes, we will be in catastrophic failure by then. What this reauthorization needs to do is begin the process. One way of beginning is including a provision to start a commission, and I mean an external group of experts at blue-ribbon level, that can oversee a process of comprehensive in-depth assessment and analysis. That doesn’t lend itself to the [Institute of Medicine] process that’s been used. It needs to be directly associated with a bipartisan, multitalented commission. They’d have the responsibility to get this done in a year: deciding what are the structural and functional issues at the agency that must be addressed.
NJ What would you change about your FDA tenure?
Von Eschenbach It was too short to accomplish and do all the things I wanted to do and that I saw needed to be done. Something that was essential and critical was that the agency needed to be resuscitated, because it was resource-deprived. I went about the process of acquiring additional resources. So by the time I left, we had increased the workforce by almost 30 percent, rebuilt the entire IT infrastructure, and turned the agency into a global regulatory agency by opening FDA offices around the world: in China, India, Central America, Europe, and we had plans to do it in the Middle East. But we didn’t get to do all the other things I wanted to do. There were many initiatives I had the opportunity to get started, but there were many more I would’ve liked to implement. Fortunately, Dr. [Margaret] Hamburg [the current FDA commissioner] has carried on and continued to do many, many things.
NJ What’s your favorite smartphone app?
Von Eschenbach Quite honestly, my favorite app is being able to get books—whether its Amazon or Kindle or iTunes—I love being able to download books and being able to read on the go.
NJ What are you reading now?
Von Eschenbach I’m interested in some of the analysis of what’s happened to our military in Afghanistan and Iraq, and parallels to our experiences in the Vietnam War. I was a lieutenant commander in the Navy Medical Corps. I saw firsthand the sacrifices the military goes through. It’s the same thing that’s emerging now. I have a nephew who is a lieutenant commander; he’s a Ranger, he’s Airborne, and he’s flown in Afghanistan and Iraq. He’s seen the tremendous toll these things take on the best and most wonderful part of our country. I don’t like to just confine myself to medicine.
This article appears in the April 28, 2012, edition of National Journal.