FDA Commissioner Lester Crawford on Friday unexpectedly resigned his post amid criticism over "politically tinged" issues, including the agency's action last month to indefinitely postpone a decision on Barr Laboratories' application for nonprescription sales of its emergency contraceptive Plan B to women ages 17 and older, the Wall Street Journal reports. FDA offered no official explanation for Crawford's resignation, but people familiar with the matter said it was connected to stock holdings Crawford might have failed to disclose, according to the Journal (Wilde Mathews et al., Wall Street Journal, 9/24). An unnamed government official said the resignation was related to Crawford's failure to reveal all of his financial information to the Senate before his confirmation as commissioner, the New York Times reports. Ira Loss -- a senior health analyst for Washington Analysis, which studies federal issues for investors -- said the agency's delay of Barr's application was not the reason for Crawford's resignation because he "did what they wanted on Plan B" (Pear/Pollack, New York Times, 9/24). The agency in May 2004 issued a "not approvable" letter in response to Barr's original application to allow Plan B to be sold without a doctor's prescription and in January delayed a ruling on Barr's revised application, which would allow EC to be sold without a doctor's prescription only to women ages 17 and older. Crawford at a press conference last month opened a 60-day public comment period on Barr's application and said that science supported giving nonprescription access to Plan B to women ages 17 and older but added that the application presented FDA "with many difficult and novel policy and regulatory issues," including how to keep girls age 16 and younger from obtaining the drug (Kaiser Daily Reproductive Health Report, 9/2).

Bush Names NCI Director von Eschenbach Acting Commissioner
Within an hour of FDA announcing Crawford's resignation, the White House announced that President Bush had asked National Cancer Institute Director Andrew von Eschenbach to serve as acting FDA commissioner effective immediately, the Washington Post reports (Kaufman, Washington Post, 9/24). Von Eschenbach, who has served as NCI director since January 2002, said he will handle the duties of both positions and did not give any indication whether he expects to be nominated for FDA commissioner, the AP/Yahoo! News reports. He declined to discuss specifics about Barr's application (Lumpkin, AP/Yahoo! News, 9/25). However, von Eschenbach did say that he will strike an "appropriate balance" in evaluating the risks and benefits of drugs (Pear et al., New York Times, 9/25).

Crawford Comments, Reaction
Crawford in a brief resignation message to his staff thanked Bush, HHS Secretary Mike Leavitt and "the extraordinary people of FDA for the honor of having served with them. ... After three and a half years as deputy commissioner, acting commissioner and finally as commissioner, it is time ... to step aside" (Pugh, Knight Ridder/San Jose Mercury News, 9/23). Sen. Patty Murray (D-Wash.), who last week unsuccessfully attempted to cut FDA's budget in an agricultural appropriations bill in response to the delay in Barr's Plan B application, said, "Crawford's ability to lead a strong and independent FDA was in question from the start" (Henderson, Boston Globe, 9/24). Although Murray was not successful in pushing through the budget cut, she did persuade the Senate to include language in the appropriation bill that calls for an expedited decision on Plan B (Washington Post, 9/24). Sen. Hillary Rodham Clinton (D-N.Y.), who earlier this year along with Murray put a hold on Crawford's nomination for commissioner because of the delay in Barr's Plan B application, said in a statement, "With the resignation of Dr. Crawford, the FDA has a real opportunity to restore its battered reputation and nominate a leader with vision and drive to ensure that the FDA upholds its gold standard of drug regulation" (Graham, Chicago Tribune, 9/25). When asked if Crawford was forced to resign, Leavitt spokesperson Christina Pearson refused to comment (New York Times, 9/24).