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【技术产业】最新FDA局长访谈录: 业内观察
针对外界和媒体批评, FDA新任局长开口力挺负责药品安全监管的重要部门, 坦率陈述其对药品安全,DTC广告,FDA 文化,和迈向个性化药物时代的计划的看法和展望
Jun 1, 2007
By: Patrick Clinton, Jill Wechsler
Pharmaceutical Executive
第一部分
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?
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.
第二部分
We are growing our ability to understand these products and their impact on patients in a way that helps us manage both safety and efficacy simultaneously—so we see the science of safety emerging as well as the science of efficacy. Even in experimental models, we are now able to determine the effectiveness of a drug by understanding its on-target effects—for example, in the tumor for which it is designed—and to understand at the molecular level its off-target effects in terms of what might be happening to the liver or the endothelium of a heart or to the nervous system.
A Brief History
As we bring those two pieces of the equation closer together through the prism of science, we're going to be able to more rapidly approve drugs and do it more reliably with regard to understanding the risk/benefit ratio. I see things going rapidly and safely all at the same time.
The parameters around safety seem to be growing and changing at the same time. Where have you seen progress?
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作者:admin@医学,生命科学 2011-03-24 18:59
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