By Marc Kaufman
Washington Post Staff Writer
Thursday, March 16, 2006
President Bush yesterday nominated Andrew C. von Eschenbach, the director of the National Cancer Institute and a three-time cancer survivor, to be permanent commissioner of the Food and Drug Administration.
If confirmed by the Senate, von Eschenbach, who has served as acting FDA commissioner since the abrupt departure of Lester M. Crawford in September, would take over a troubled agency that regulates almost one-quarter of the American economy.
The FDA has been without a permanent commissioner for much of the Bush administration -- a void that many elected officials and FDA experts say has diminished its reputation and effectiveness. Despite broad agreement that the agency needs permanent leadership, however, the prospects for a quick confirmation appeared slim.
Within minutes of the formal nomination, Sens. Hillary Rodham Clinton (D-N.Y.) and Patty Murray (D-Wash.) announced that they will not allow a vote on it until the FDA acts on a controversial proposal to make the "morning-after" pill available without a prescription.
That application has been pending for more than two years, and the administration's handling of the issue has created substantial ill will among Senate Democrats. Most major medical societies have also criticized the FDA's handling of the emergency contraception issue, saying that it was based on ideology rather than science.
The decision to nominate von Eschenbach for the permanent position -- which had been widely rumored in recent weeks -- appeared to represent a shift in administration thinking. After he was named the acting agency head, Health and Human Services Secretary Mike Leavitt said that he would probably return to the Cancer Institute, adding: "Andy is acting commissioner, and I suspect that will be his status until we fill it permanently."
Yesterday, Leavitt hailed von Eschenbach's career as one that "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." He added: "The FDA needs permanent leadership to spur more innovation, improve drug safety and help lifesaving drugs reach patients faster."
Before joining the National Cancer Institute, von Eschenbach spent 25 years at the University of Texas M.D. Anderson Cancer Center in Houston, ultimately serving as chief academic officer. In that position, he led a faculty of nearly 1,000 cancer researchers and clinicians. He has survived three cancer diagnoses: melanoma, prostate cancer and basal cell carcinoma.
During his time at M.D. Anderson and the Cancer Institute, von Eschenbach, 64, spoke frequently of eliminating the suffering and death of cancer by 2015. While the goal has inspired some -- the American Association for Cancer Research, for instance, applauded his nomination yesterday, citing his proven drive to translate new discoveries into new medications -- it has troubled others.
"Eradicating cancer within 10 years is not realistic, and by making this statement, von Eschenbach is cruelly raising people's hopes," said Sidney M. Wolfe, director of Public Citizen's Health Research Group. He called von Eschenbach "someone who has been warmly embraced by the regulated industries -- especially the pharmaceutical industry -- and someone who has been and will continue to be loyal to the White House agenda."
The biggest hurdle to confirmation, however, is likely to involve the application to make the "morning-after pill" more easily available -- a proposal that was enthusiastically endorsed by the FDA staff and an expert advisory panel. But social and religious conservatives opposed the proposal, saying that it could encourage promiscuity or that its mechanism of action could itself result in very early abortions, a position that most medical experts dispute.
The FDA rejected the application in 2004 and then announced last September that it needed to begin a lengthy rulemaking process to determine if it could approve nonprescription sale of the contraceptive, known as Plan B.
Clinton and Murray, who had earlier blocked a vote on Crawford's nomination, allowed the vote to take place after Leavitt promised the Plan B issue would soon be resolved. The two senators said yesterday that they had been "double-crossed."
Von Eschenbach was scheduled to meet with Clinton and Murray last week but canceled on the day the meeting was to take place.
After he was confirmed, Crawford lasted in the job less than three months. The reasons for his sudden resignation remain unclear, and Crawford said simply that it was time for someone new to lead the agency. The Senate committee that endorsed the nomination, as well as several members of the House, requested a formal inspector general's investigation of the resignation, which is underway.
Soon after being named acting commissioner, von Eschenbach was criticized for holding on to his previous position as head of the National Cancer Institute as well. He responded by saying he would give up day-to-day leadership of the institute and would, "as a prudential matter," recuse himself from FDA matters in which NCI was a party, including applications to approve new cancer drugs.
The FDA "needs a permanent commissioner who's willing and able to take on its entrenched cultural problems and turn them around," Sen. Charles E. Grassley (R-Iowa), a persistent critic of the FDA's handling of drug safety issues, said in a statement. "That task is like turning around an aircraft carrier, and it'll take a very determined, reform-minded individual to do it."