Von Eschenbach To Take Temporary Leave as NCI Director While Serving as Acting FDA Commissioner
Acting FDA Commissioner Andrew von Eschenbach on Friday said that he will take a temporary leave of absence as director of the National Cancer Institute to address conflict-of-interest concerns, the Washington Post reports (Weiss, Washington Post, 10/1). President Bush named von Eschenbach acting FDA commissioner after former agency Commissioner Lester Crawford resigned last month (California Healthline, 9/30).
In recent weeks, some health care experts and lawmakers have raised concerns because, as acting FDA commissioner, von Eschenbach could have the ability to approve medications that he helped develop at NCI. Critics also said the Bush administration should appoint a permanent FDA commissioner (AP/Baltimore Sun, 10/1). In a memo to FDA employees on Friday, von Eschenbach said that HHS Secretary Mike Leavitt has asked John Niederhuber, deputy director for translational and clinical sciences at NCI, to serve as "chief operating officer to handle day-to-day management" at the agency.
Von Eschenbach also said that, "as a prudential matter," he will not participate in certain FDA matters related to NCI (Washington Post, 10/1). According to CQ HealthBeat, those matters include the review of applications for medications, medical devices or biologics submitted to FDA by NCI and applications for which an NCI researcher served as principal investigator (CQ HealthBeat, 9/30). Von Eschenbach also has a potential conflict of interest related to his position as vice chair of the board of C-Change -- a not-for-profit organization led by George H.W. and Barbara Bush that also involves officials from Bristol-Myers Squibb and Johnson & Johnson -- according to the Cancer Letter.
Von Eschenbach said, "I look forward to bringing my experience on the discovery side of medicine to the delivery side of medicine, making sure patients get the drugs and treatments they need as quickly and safely as possible."
Sen. Edward Kennedy (D-Mass.) on Friday said von Eschenbach's decision to take a temporary leave of absence as NCI director "does not go far enough." He added, "FDA deserves a commissioner who can commit completely to this important responsibility," and NCI "deserves a full-time director" (Washington Post, 10/1). In addition, Kennedy said that "key health priorities important to the American people" will "lose out" under the arrangement (CQ HealthBeat, 9/30).
Sen. Barbara Mikulski (D-Md.) said, "I look forward to the swift appointment of a full-time, permanent, competent FDA commissioner" (Washington Post, 10/1).
The New York Times and Wall Street Journal recently published several letters to the editor related to FDA issues. Summaries appear below.
- Henry Miller, New York Times: The "excessive risk aversion and defensive decision-making" at FDA have "vastly increased the time and expense of drug development" and pose a "threat to public health," Miller, a Hoover Institution fellow and former FDA official, writes in a letter to the editor of the Times. According to Miller, "FDA officials have arbitrarily directed clinical investigators to begin trials at inappropriately low doses; limited the approval of early stage studies only to single-dose studies; ... demanded unnecessary, invasive procedures on patients; required that foreign trials be completed and the results submitted before the Unites States trials could begin; and too quickly pulled the plug on the testing of promising new drugs" (Miller, New York Times, 10/2).
- Sen. Chuck Grassley (R-Iowa), Wall Street Journal: A Sept. 27 Journal editorial "underscores my strong belief" that the relationship between FDA and pharmaceutical companies "is too cozy," Grassley writes in a Journal letter to the editor. However, the editorial "misrepresents the case I've made about problems" at FDA, Grassley writes, adding, "My criticism of the close relationship is not based on the fact that pharmaceutical companies pay user fees to the FDA. I've said repeatedly that those fees don't account for the problem and eliminating them would not be a good solution" (Grassley, Wall Street Journal, 9/30).
- Richard Ralston, Wall Street Journal: "There are many potential ways to evaluate the safety of new drugs," but those methods "must not unnecessarily delay approving drugs that can save lives," Ralston, executive director of Americans for Free Choice in Medicines, writes in a letter to the editor of the Journal. Ralston writes that independent laboratories "can probably do this better than a monolithic federal bureaucracy" such as FDA (Ralston, Wall Street Journal, 9/30).