By Jeffrey Young - 01/24/08 12:01 AM EST
Andrew von Eschenbach left behind the National Institutes of Health and a lifetime in cancer research to take over as commissioner of the Food and Drug Administration (FDA) in 2005. Von Eschenbach, who has longstanding ties to President Bush’s family, filled a leadership void at an agency many viewed as troubled.
At von Eschenbach’s request, a blue ribbon scientific panel issued a report last year assessing the FDA’s fitness to protect the safety of the nation’s foods and medicines. The report offers a sobering portrait of an agency unable to fulfill its core mission, owing largely to what it calls a “growing disparity between responsibilities and resources.” A House Energy and Commerce Committee panel plans a hearing on the report next Tuesday.
Near the end of a decade that has seen tainted-food scares and popular drugs pulled from the market because of deadly side effects, the task of bringing the agency to full strength is no mean one.
Q: Successive administrations and Congresses have agreed that the FDA needs more funding, but neither branch has actually called for that. What do you think should be the first step to breaking this logjam?
Breaking that logjam, if you want to put it that way, is to not only ask for more funding, which I’m doing and which I’ve done in each of the budget proposals, but also present to Congress a rationale and a game plan for how those dollars would be used, what they would be applied to and what the return on investment would be to the American people for making that investment.
No. I actually think, quite candidly, that the FDA should be based on a very broad foundation of resources. … The taxpayer continues to be the greatest source of funding but I don’t think the burden should fall entirely on the taxpayer because I believe there are functions and services that the FDA provides, for example, that are of direct benefit to the industries that we regulate and those industries should absorb the cost of those services appropriately as user fees. [I]t’s also important for the taxpayer to know that … does not result in the industry taking control of our regulatory process or responsibility.
Q: A law enacted last year gave the FDA a stronger hand in enforcing drug safety as well as a substantial increase in the amount of money it gets from user fees. What are the top priorities and major challenges facing you as you begin implementing that law?
I think the biggest issue … is the development of the information technology and data systems that have to be the infrastructure upon which we’ll be able to implement those enhanced initiatives for ensuring drug safety, [such as] the post-market surveillance piece. … The other challenge is to move to the front end where we need to learn more and know more about these drugs and their mechanisms of action … before they ever even get introduced into humans.
Q: Critics of the FDA complain at times that the agency approves new drugs and devices too quickly and at other times moves too slowly. At present, the pace of approvals appears to have slowed. Have you changed anything about the review and approval process that could account for this?
No, I have not, and I don’t believe our own internal data supports those perceptions or those conclusions. Obviously, what we approve is dependent upon what we receive in the form of applications. People have looked at those numbers and suggested that somehow FDA is slowing down and I don’t believe the data supports that. … From my point of view, I want to see the FDA be a bridge and not a barrier to getting all of these wonderful new opportunities, solutions, to patients. … We want to create that regulatory pathway in a way that is free of speed bumps or pathways that are unnecessary … but with very strong guardrails.
Q: Some observers think that the era of the “blockbuster” drug is over and that the brightest future for drug development lies in personalized medicine. In what ways must the FDA adapt to meet its responsibilities in the future as the nature of drug development changes?
We’re in the molecular era where we’re not just observing the manifestations of the disease, like the fact that a woman has a lump in her breast and [therefore] has breast cancer, but we’re actually beginning to understand the mechanism of those diseases. … In this era of personalized medicine, it’s not just enough to define a new drug, it’s also important to understand for whom is that new drug appropriate.
Q: In light of the recent scares about the safety of imported foods and the Bush administration’s renewed focus on import safety broadly, how do you view the adequacy of the FDA’s authorities and resources to ensure the safety of our food supply?
If FDA continues to do business the way it has done in the past, even though in the past we were the gold standard, we’ll be inadequate for the future. … We have to collaborate and cooperate and move to [the countries] where these products, this food, is being grown and produced and supplied. If we stand at our borders and try and inspect problems out, we’ll fail. …
Q: This is most likely your final year as commissioner. What are the most important pieces of unfinished business you’d like to wrap up?
I frankly carry with me the cancer patient’s mantra that the only thing you’re really guaranteed is today, so make the most of today. … I respect that I inherited a history and I fully expect to contribute to a history by setting a trajectory in place.