FDA Nominee Could Stumble on Issue of ‘Morning After’ Pill
President Bush on Wednesday nominated acting Commissioner Andrew C. von Eschenbach to permanently head the troubled Food and Drug Administration, but a controversy involving science and sexual mores could stall his confirmation by the Senate indefinitely.
Democratic Sens. Hillary Rodham Clinton of New York and Patty Murray of Washington announced Wednesday that they would block a floor vote on the nomination until the FDA made a firm decision on the controversy -- whether or not to allow Plan B, the “morning after” birth control pill, to be sold without a prescription.
The same issue delayed confirmation of Von Eschenbach’s predecessor, Lester M. Crawford, and is believed to have contributed to Crawford’s precipitous resignation last fall.
The agency’s scientific staff has long concluded that the contraceptive is safe and effective for over-the-counter use by women of all ages, according to internal memos recently released by Rep. Henry A. Waxman (D-Los Angeles). But senior FDA officials have repeatedly delayed a final decision. That has prompted some in the medical community, as well as Democrats such as Clinton and Murray, to charge that the agency compromised its scientific judgment under pressure from social conservatives influential in the Bush administration.
“This nomination will not move forward until there is a yes-or-no decision on Plan B,” Murray said.
Von Eschenbach, 64, director of the National Cancer Institute and a renowned prostate cancer surgeon from Texas, has headed the FDA since the fall, when Crawford unexpectedly quit two months after being confirmed.
If Von Eschenbach is confirmed, he is expected to focus on streamlining the FDA process for approving new medications aimed at hard-to-cure diseases, such as several types of cancer. The agency also must establish a framework for regulating emerging fields such as genetic medicine. At the same time, the FDA is struggling to repair its image as a safety watchdog.
Von Eschenbach’s nomination had been expected for several weeks.
Health and Human Services Secretary Mike Leavitt called him an “inspired choice.” Not only does Von Eschenbach have an extensive medical resume, he also has been a cancer patient, having been treated for melanoma and prostate cancer.
“FDA needs permanent leadership to spur more innovation, improve drug safety and help life-saving drugs reach patients faster,” Leavitt said.
The administration has given no indication that it intends to resolve the Plan B controversy.
In a statement, the FDA suggested that because Von Eschenbach had not been involved with the issue, his nomination should be considered apart from the controversy. “He demonstrated strong leadership skills during his time [as a practicing physician] and at NCI and this experience will be very helpful at FDA,” the statement said. “Dr. Von Eschenbach will be driven by science in making crucial decisions.”
Senior Republicans warned the White House that the nomination would run into trouble without a decision on Plan B. Sen. Michael B. Enzi of Wyoming “strongly encouraged the administration to resolve the issue before moving forward to nominate,” said his spokesman, Craig Orfield. Enzi heads the Health, Education, Labor and Pensions Committee, which oversees the FDA.
“It is obviously going to be more difficult to move the nomination if that issue is not resolved,” Orfield said.
Plan B has been available by prescription since 1999, but a decision on over-the-counter sales has been stalled. The contraceptive contains a higher dose of a hormone that is in regular birth-control pills; it is most effective in preventing pregnancy when taken in the first 24 hours after unprotected sex.
The previous commissioner, Crawford, had promised Enzi and other senior senators a firm decision on Plan B.
That enabled the senators to persuade Clinton and Murray to allow a floor vote on Crawford’s nomination. Under Senate procedures, individual senators have the power to block such nominations as a matter of personal privilege.
But last summer, Crawford balked at reaching a decision. The FDA “double-crossed” the public, Murray said.
FDA memos released last week by Waxman suggest that agency regulators did not see any major obstacle in allowing over-the-counter sales for most women, with prescriptions required for young teenage girls. Such a compromise was suggested by senior FDA officials two years ago.
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