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Appointing New FDA Commissioner
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No Timetable To Nominate New FDA Commissioner, HHS Secretary Leavitt Says
Kaiser Daily Health Policy Report
Tuesday, September 27, 2005
HHS Secretary Mike Leavitt on Monday said that "there is no timetable" for the nomination of a permanent FDA commissioner after Lester Crawford resigned on Friday, CQ HealthBeat reports (CQ HealthBeat, 9/27). Crawford resigned two months after his confirmation as FDA commissioner in July. In an e-mail to FDA employees, Crawford wrote that "after three and a half years as deputy commissioner, acting commissioner and, finally, as commissioner, it is time, at the age of 67, to step aside." In a letter to President Bush on Friday, Crawford said that his resignation was "effective immediately." Crawford, a veterinarian and a food safety expert, became FDA deputy commissioner in 2002 and later became acting agency commissioner. Bush named Andrew von Eschenbach, director of the National Cancer Institute, as acting FDA commissioner (Kaiser Daily Health Policy Report, 9/26). Von Eschenbach on Monday in an e-mail to cancer research advocates called his appointment "an interim role" and said that he will "work to ensure an orderly transition of a new, permanent commissioner at the FDA" (Alonso-Zaldivar, Los Angeles Times, 9/27). However, CQ HealthBeat reports that "von Eschenbach may be running the agency on an acting basis for a considerable time." According to an unnamed Washington, D.C., consultant, "The candidate pool has weakened considerably," and an "abortion litmus test" has eliminated some "strong" candidates who support abortion rights (CQ HealthBeat, 9/26). Von Eschenbach said that he will continue to serve as NCI director during his tenure as acting FDA commissioner, adding that he hopes to "closely integrate the discovery aspects of biomedical research" with the FDA approval process to provide patients with "the full benefits of molecular medicine"
Ability To Head Two Agencies Questioned
In a letter to White House Chief of Staff Andrew Card on Friday, Senate Finance Committee Chair Chuck Grassley (R-Iowa) wrote that Bush should not name von Eschenbach as acting FDA commissioner because an individual who heads both FDA and NCI will not have the ability to "dedicate 100% of his or her time and talent to the nation's public health and safety agency." Grassley said, "It's not possible to give the FDA the kind of strong leadership that is needed to reinvigorate the agency on a part-time basis" (Pear, New York Times, 9/27). New England Journal of Medicine Editor in Chief Jeffrey Drazen said, "These are agencies with big budgets that make a lot of decisions that influence the health of individual Americans. What we really need are two highly qualified, motivated individual leaders" (Los Angeles Times, 9/27). However, Billy Tauzin, president and CEO of the Pharmaceutical Research and Manufacturers of America, said that the leadership of von Eschenbach and the "expertise of dedicated veteran FDA regulators will allow the agency to continue its important work until a new commissioner is nominated and confirmed" (Higgins, Washington Times, 9/27). In a research note, Prudential Securities analyst Diane Duston said that von Eschenbach could face difficulties as head of both FDA and NCI, adding that the Bush administration might have to name an acting NCI director (Heavey, Reuters News, 9/26).
Conflict-of-Interest Concerns
Some critics questioned whether von Eschenbach has a conflict of interest as the head of both FDA and NCI. Curt Furberg, a professor at Wake Forest University and an FDA adviser, said, "It is very hard for him to be in both positions and deal with requests regarding cancer drugs. I really see a potential conflict. As head of NCI, he may be very eager to get drugs approved by FDA, particularly drugs that have been developed and tested by NCI" (Los Angeles Times, 9/27). Citigroup health care analyst Paul Heldman said that von Eschenbach "appears to be industry friendly, particularly in the oncology area," adding that von Eschenbach "transformed [NCI] from a research center to one that generates cancer treatments and strategies for prevention" (CQ HealthBeat, 9/26). According to Diana Zuckerman, president of the National Research Center for Women and Families, von Eschenbach "is talking about getting drugs to terminally ill patients faster, and that's a laudable goal. But you can't approve a drug and assume it will only be used for terminally ill patients. Everything he has been quoted as saying suggests he doesn't understand how FDA works" (Los Angeles Times, 9/27). Michael Jacobson, executive director of the Center for Science in the Public Interest, said, "The FDA does not need someone who will choose speed over safety, or else we'll have a lot more Vioxx" cases (Washington Times, 9/27).
Editorials
Several newspapers recently published editorials that addressed the resignation of Crawford and the appointment of von Eschenbach as acting FDA commissioner. Summaries appear below.
* Long Island Newsday: The "troubled FDA needs a permanent, full-time commissioner who will ensure that decisions about the safety and effectiveness of drugs ... will be based on credible science, uncolored by political agendas," according to a Newsday editorial. The editorial states, "Re-establishing its tarnished credibility has to be among the agency's top priorities now," as FDA "is too important to let reasonable doubts about its objectivity and capabilities continue to fester" (Long Island Newsday, 9/27).
* New York Times: The "stopgap solution" to the "surprise resignation" of Crawford -- the appointment of von Eschenbach, the NCI director, as acting FDA commissioner -- "can only weaken both agencies," a New York Times editorial states. According to the editorial, FDA, "with regulatory jurisdiction over huge swaths of the economy, surely needs a full-time steward," as the "interim appointment could stretch out for some time." In addition, von Eschenbach "emphasizes ... a stance that could lead to looser regulation," although "FDA's recent problems suggest a need to monitor drugs more closely," the editorial concludes (New York Times, 9/27).
* Wall Street Journal: The "problem" with FDA "has been largely one of inattention and failure to modernize, not reckless drug approvals or cozy relationships with Big Pharma," according to a Journal editorial. The appointment of von Eschenbach as acting FDA commissioner is an "encouraging sign that the administration may finally be taking the FDA seriously" because he "understands that the FDA's job isn't merely to police the pharmaceutical companies but also to speed good therapies to patients," the editorial states (Wall Street Journal, 9/27).
Broadcast Coverage
WAMU's "The Diane Rehm Show," an NPR-syndicated program, on Tuesday in the first hour is scheduled to include a discussion of the future of FDA after the Crawford resignation. Guests on the program are scheduled to include John Calfee, resident scholar at the American Enterprise Institute; David Kessler, former FDA commissioner; Julie Rovner, NPR health policy correspondent; and Susan Wood, former assistant commissioner of the Office of Women's Health at FDA (Rehm, "The Diane Rehm Show," WAMU, 9/27).
The complete segment will be available online in RealPlayer and Windows Media after the broadcast.
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