Institutionalized Ethics
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When Andrew von Eschenbach, MD, was sworn in as commissioner of FDA late last year, he walked into an agency that was under
fire but also in the midst of immense and complicated change.
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.
Speaking slowly and deliberately, von Eschenbach clearly has a strong sense of institution and of how to make an agency run.
And rather than finding him resistive or paralyzed because of the critics, we found Commissioner von Eschenbach cautiously
hopeful, with a fairly clear vision of how to move FDA into the future. What follows is an edited transcript of our interview.
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?
Von Eschenbach says the agency is committed to improving patient information but notes that more in–depth, scientific research
is needed to best structure risk communications
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Just recently, Mark McClellan wrote an article [in the New England Journal of Medicine] that described this seeming societal pendulum of "we need to get things out there much more rapidly," like for HIV/AIDS,
or "we need to be much more cautious about what we are approving because of unexpected potential problems," like with the
Vioxx story.
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.
PharmExec Blog
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