A To-Do List for the New FDA Commissioner (New Eng Jour Med)

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A To-Do List for the New FDA Commissioner
Susan Okie, M.D.

http://content.nejm.org/cgi/content/full/NEJMp0810755?query=TOC

A week before President Barack Obama's inauguration, the departing commissioner of the Food and Drug Administration (FDA), oncologist Andrew von Eschenbach, compared the agency he has led for the past 3 years to a person with cancer. Responding to a new report critical of the FDA, von Eschenbach said, "It is a great shock and surprise when someone says you have cancer. . . . The truth of the matter is that the process has been going on for a long time before it becomes apparent."1

Von Eschenbach's metaphor, although startling, was apt: the new commissioner of the FDA will take over an agency with serious systemic problems that urgently need to be addressed. In recent years, various reports have portrayed an FDA burdened by ever-expanding responsibilities in the face of a mostly flat annual budget, much of which comes from fees paid by the industries the agency regulates. For more than half of the past decade, the FDA has lacked a congressionally confirmed leader. A 2007 report prepared for the FDA Science Board concluded that the agency "cannot fulfill its mission" to ensure that the foods, drugs, medical devices, vaccines, and other products that it regulates are safe and effective, because it lacks modern scientific expertise, is critically underfunded and understaffed, and has a dangerously outmoded information-technology infrastructure.2 Testifying last year before a House subcommittee, Science Board chair Gail Cassell said, "We conclude that American lives are at risk and that there is an urgent need to address the deficiencies." A series of high-profile incidents — related to the FDA's handling of information about the risks associated with drugs such as rofecoxib and antidepressants; the adulteration or contamination of imported ingredients in heparin, pet food, and other products; the agency's politically motivated delay in approving over-the-counter access to "Plan B" emergency contraception; and a series of major food-poisoning outbreaks — have damaged the FDA's credibility. It is perceived as slow to act, secretive, and subject to influence by political and corporate interests.

The FDA's portfolio is vast. It is responsible for licensing new medicines, monitoring the safety of those on the market, and ensuring the safety of about 80% of the country's food supply. It also regulates medical devices used for diagnosis, surgical implantation, and treatment; dietary supplements; biologics such as vaccines and cell-based or tissue-based therapies; the blood supply; radiation-emitting products, such as cell phones, computer monitors, and microwave ovens; cosmetics; and drugs and feed for animals — all in all, products accounting for about one quarter of annual spending by U.S. consumers. And tobacco products may soon be added to that list. With increasing globalization, ensuring safety requires the FDA to monitor ingredients and processes in factories located overseas. And advances in genetic engineering and genomics, nanotechnology, robotics, stem-cell biology, and other fields raise unprecedented regulatory challenges that require expertise and decision making in new areas of science.

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Although commissioners often take on the job because they are interested in a specific issue, fixing the FDA will require a leader who is passionate about the agency and its mission as a whole. By restoring science to its rightful status, by forcefully advocating for needed resources, and by improving the FDA's record as a guardian of public health, the new commissioner will most effectively serve the American people.

Source Information
Dr. Okie is a national correspondent for the Journal.

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http://content.nejm.org/cgi/content/full/NEJMp0810755?query=TOC

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