Bush Nominates von Eschenbach for FDA Commissioner

President Bush on Wednesday nominated acting FDA Commissioner Andrew von Eschenbach to become permanent head of the agency, the New York Times reports. Von Eschenbach, who also is director of the National Cancer Institute, was appointed acting commissioner for FDA in September 2005 after then-Commissioner Lester Crawford's unexpected resignation (Harris, New York Times, 3/16).

Von Eschenbach plans to resign from his position at NCI, according to HHS spokesperson Christina Pearson (Bridges, AP/San Francisco Chronicle, 3/15).

The Washington Post reports that "the prospects for a quick confirmation" for von Eschenbach "appeared slim" on Wednesday after Sens. Patty Murray (D-Wash.) and Hillary Rodham Clinton (D-N.Y.) announced that they have placed a hold on the confirmation vote, which they will maintain until FDA makes a decision on whether to make Barr Laboratories' emergency contraceptive Plan B available without a prescription (Kaufman, Washington Post, 3/16).

FDA in May 2004 issued a "not approvable" letter in response to Barr's original application to authorize nonprescription sales of Plan B, citing inadequate data on its use among girls under age 16. After FDA rejected Barr's first application, the company submitted a revised application to make nonprescription Plan B available only to women ages 17 and older (California Healthline, 2/17).

In February 2005, Murray and Rodham Clinton placed a hold on Crawford's nomination as FDA commissioner until the agency reached a decision on the Plan B application. Crawford was confirmed after Senate Health, Education, Labor and Pensions Committee Chair Mike Enzi (R-Wyo.) reached a compromise between the senators and HHS Secretary Mike Leavitt, who promised that the agency would "act" on the application by September 2005 (New York Times, 3/16).

Crawford in August 2005 announced that the agency would indefinitely defer the application and opened a 60-day public comment period on it, which expired on Nov. 1, 2005 (California Healthline, 2/17).

Because of the hold on the nomination, von Eschenbach might "never be confirmed by the Senate during Bush's term," Long Island Newsday reports (Thrush, Long Island Newsday, 3/16).

Rodham Clinton said, "We were rudely surprised when the FDA announced it would further study the decision, so we are putting everybody on notice that we are placing a hold on this nomination and will not lift it until we have a decision."

The Senate can override such a hold through a "time-consuming process and a motion requiring a 60-vote majority," the AP/Chronicle reports (AP/San Francisco Chronicle, 3/15).

Enzi is "unlikely to push for a deal" in order to win von Eschenbach's confirmation, as he did with Crawford, because he "spent considerable political clout to persuade" Murray and Rodham Clinton to allow a vote on Crawford's nomination last year, the New York Times reports (New York Times, 3/16). Enzi said he will hold a confirmation hearing as quickly as possible (AP/San Francisco Chronicle, 3/15).

As permanent commissioner, von Eschenbach likely would focus on streamlining FDA's process for approving new medications for hard-to-cure diseases like certain cancers. FDA also must "establish a framework for regulating emerging fields such as generic medicine," the Los Angeles Times reports (Alonso-Zaldivar, Los Angeles Times, 3/16).

Before joining NCI, von Eschenbach worked for 25 years at Houston's University of Texas M.D. Anderson Cancer Center, where eventually he served as chief academic officer. He has survived melanoma, prostate cancer and basal cell carcinoma.

While at M.D. Anderson and NCI, von Eschenbach often spoke of eliminating suffering and death from cancer by 2015, a goal that some applauded but others criticized as too optimistic, the Post reports.

FDA has been without a permanent commissioner for much of Bush's presidency, which some lawmakers and FDA experts say has "diminished its reputation and effectiveness," according to the Post (Washington Post, 3/16).

White House spokesperson Ken Lisaius said, "The FDA needs a full-time commissioner. We hope the Senate gives the nominee timely consideration and provides him with an up-or-down vote" (Long Island Newsday, 3/16).

Leavitt said, "The FDA needs permanent leadership to spur more innovation, improve drug safety and help lifesaving drugs reach patients faster." He added that von Eschenbach "has been defined by his vision for progress in research and passion for the care of patients -- two qualities which will serve the agency and the American public well" (Washington Post, 3/16).

Craig Orfield, spokesperson for Enzi, said the senator "strongly encouraged the administration to resolve" issues surrounding the Plan B application "before moving forward to nominate." Orfield said, "It is obviously going to be more difficult to move the nomination if that issue is not resolved" (Los Angeles Times, 3/16).

Sen. Edward Kennedy (D-Mass.), ranking member on the Senate HELP committee, said, "The administration will have to address the Plan B issue fair and square before he can be confirmed."

Norman Ornstein, a scholar at the American Enterprise Institute, predicted that the Bush administration would allow von Eschenbach to remain unconfirmed for years rather than approve the Plan B application, which is opposed by Bush supporters who are anti-abortion. "They are not going to enrage their base," Ornstein said (New York Times, 3/16).

NPR's "Morning Edition" on Thursday reported on von Eschenbach's nomination and Plan B. The segment includes comments from Margaret Foti, CEO of the American Association for Cancer Research; Kirsten Moore, president of the Reproductive Health Technologies Project; and Murray (Rovner, "Morning Edition," NPR, 3/16). The complete segment is available online in RealPlayer.