The view from inside

June 1, 2007

Urologist Andrew von Eschenbach, MD, was named commissioner of the Food and Drug Administration in 2006. In this exclusive interview, from Urology Times sister publication Pharmaceutical Executive, he discusses drug safety, DTC advertising, FDA's culture, and how the agency plans to bring itself into the age of molecular medicine.

Part of the maelstrom was inherited from the previous commissioner, Lester Crawford, whose abrupt departure was surrounded by a cloud of questions over Plan B and who later pleaded guilty to conflict-of-interest charges. But in many ways, those issues paled in comparison to what loomed ahead for von Eschenbach: reinventing the way FDA thinks about drug safety, responding to the demand for a regulatory pathway for follow-on biologics, and, yes, even ensuring that the nation's supply of bagged spinach was free of E. coli. Of course, the truly difficult part was to provide leadership to enact change when public trust in FDA was at an all-time low.

But in many respects, there may not have been a more perfect time for von Eschenbach-a seasoned oncologist and three-time cancer survivor who wears the yellow rubber bracelet of the Lance Armstrong LiveStrong campaign-to lead FDA. As former head of the National Cancer Institute, he understands the need to improve access to cutting-edge drugs and the need to get out in front of the science through initiatives like Critical Path.

We read in the papers that FDA is in total disarray and that Americans are dying because it can't control the safety of drugs. That's the picture from the outside. But what's it like on the inside?

When you look at the depth and breadth and complexity of the portfolio FDA is responsible for, not a day goes by that we don't address issues that are of great significance and urgency to the American people. With so much going on that is of such importance to every single American-covering food and drugs and biologics and devices-it's easy for someone looking in from the outside to see a maelstrom, to see this tremendously bubbling cauldron of things that are happening. And yet, from the inside, what I see is an enormous degree of professionalism, experience, competence, talent, and commitment that manages things effectively day in and day out. I have an enormous amount of confidence and respect for the capabilities of this agency, and I don't see it as in disarray. I see it as an agency that is just simply dealing with an enormously large and complex set of issues on a day-to-day basis.

One of the big topics, of course, is safety. It was only 10 years ago that Newt Gingrich denounced FDA and pressed it to more quickly approve drugs. Now critics are calling on you to take more time to evaluate drugs. Do you think that we're at the end, or merely the middle, of the safety pendulum swing?

I frankly reject that premise. In the modern era of molecular medicine, we shouldn't see things as being at either end of a spectrum-where drugs are either effective or safe.