FDA Commissioner Crawford Resigns; NCI Director Named Acting Commissioner
FDA Commissioner Lester Crawford on Friday "abruptly" resigned only two months after his confirmation to the position, the AP/Chicago Sun-Times reports (Neergaard, AP/Chicago Sun-Times, 9/24). In an e-mail to FDA employees, Crawford wrote that "after three and a half years as deputy commissioner, acting commissioner and, finally, as commissioner, it is time, at the age of 67, to step aside" (Carey, CQ HealthBeat, 9/23). In a letter to President Bush on Friday, Crawford said that his resignation was "effective immediately."
Crawford, a veterinarian and a food safety expert, became FDA deputy commissioner in 2002 and later became acting agency commissioner. The Senate confirmed Crawford as permanent FDA commissioner in July.
Christina Pearson, a spokesperson for HHS Secretary Mike Leavitt, declined to comment on whether the Bush administration had asked Crawford to resign, which she called a personnel issue. One federal official, who spoke on the condition of anonymity, said that the resignation involved financial information Crawford did not fully disclose to the Senate before his confirmation (Pear/Pollack, New York Times, 9/24). Other sources familiar with FDA said that the Bush administration asked Crawford to resign for undetermined reasons (Kaufman, Washington Post, 9/24).
Leavitt accepted the Crawford resignation "with sadness," Pearson said, adding, "We thank him for his service and wish him well" (Wall Street Journal, 9/23).
Crawford has had a "stormy tenure" at FDA, which in recent years has faced criticism over emergency contraception and prescription drug safety, among other issues, the Post reports (Kaufman, Washington Post, 9/24). Since 2002, FDA has "been rocked by disputes over many issues," such as the safety of the COX-2 inhibitor Vioxx, regulation of New York Times reports.
A Senate committee also investigated an alleged extramarital affair between Crawford and a woman who worked at FDA. In addition, Crawford allegedly used federal funds to take the woman on official trips for which she was not needed and helped the woman secure a promotion at FDA. The committee found that Crawford had a close relationship with the woman but no evidence of an extramarital affair (New York Times, 9/24).
Bush on Friday named Andrew von Eschenbach, director of the National Cancer Institute, as acting FDA commissioner (Wilde Mathews, Wall Street Journal, 9/26). Von Eschenbach, a cancer survivor, has said that he seeks to eliminate "suffering and death due to cancer by 2015," which some scientists consider unlikely.
He said that FDA should make new medications available "as rapidly as possible" for patients with life-threatening diseases. In addition, he said that he would seek "an appropriate balance" in the evaluation of the risks and benefits of medications at FDA (Pear/Pollack, New York Times, 9/25). However, he said, "I believe it's still important to ask the question, 'How can we accelerate the timeline? How can we make certain we are getting these interventions to the patients as quickly as possible?'" (Lumpkin, AP/Long Island Newsday, 9/26).
Von Eschenbach said that the FDA approval process for new medications represents the "gold standard" but added that, "no matter how good it is, the question always has to be asked, can we make it better?" He said that FDA should consider revisions to reduce approval times for new medications "within the context of continuing to assure their efficacy and safety," adding that "speed does not mean recklessness."
Von Eschenbach, who will continue to serve as NCI director, said that he will make a "full commitment" to leadership at NCI and FDA and that he remains "totally, completely and absolutely dedicated" to NCI. He also said that FDA should make safety information available to patients. "I absolutely believe in openness and being transparent and being clear," he said (Wall Street Journal, 9/26).
According to the Times, FDA likely "will be without a permanent commissioner for some time" because past experience "shows that it is difficult for any nominee to obtain broad support in the Senate." FDA has had a permanent commissioner for about 18 months of the four and a half years of the Bush presidency (New York Times, 9/24).
Pharmacologist Raymond Woosley, who withdrew from consideration for FDA commissioner in 2001 to accept a different job, said that Senate confirmation could prove difficult. Woosley said that the appointment of an FDA commissioner "really should be taken out of the realm of politics," adding, "It's a public health job. The head of the CDC isn't a political appointment, and it's in the same realm."
Alaistair Wood, a Vanderbilt University pharmacologist, said, "The issue is, once you've involved politics in the drug approval process, there's no way to put that genie back in the bottle."
Steven Burrill, CEO of a California-based biotechnology investment company, said that Bush might not nominate a new FDA commissioner for 18 months (Rubin, USA Today, 9/26).
Sen. Chuck Grassley (R-Iowa) praised the Crawford resignation, adding, "FDA scientists and employees are by and large hardworking and committed to fulfilling the agency's mission. They deserve a commissioner who will reinvigorate the agency" (Kaufman, Washington Post, 9/24). Grassley said, "In recent years, the FDA has demonstrated a too-cozy relationship with the pharmaceutical industry and an attitude of shielding rather than disclosing information. The opportunity to name a new commissioner is a chance to take the agency in a necessary new direction" (CQ HealthBeat, 9/23).
Sen. Hillary Rodham Clinton (D-N.Y.) said, "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" (Kaufman, Washington Post, 9/24).
Sen. Barbara Mikulski (D-Md.) criticized the leadership of Crawford as "tepid and passive," adding, "Every day, I have grown more concerned about what's going on." She said that she hopes the Crawford resignation will serve as a "move toward reforming FDA."
Peter Lurie of Public Citizen said, "In his watch, some of the worst drug disasters in the last decade took place" (Rockoff, Baltimore Sun, 9/24).
However, Peter Pitts, a former associate FDA commissioner under Crawford, said that Crawford "started to lift the veil on how the FDA does business, which was long overdue" (New York Times, 9/24).
FDA has lacked a permanent commissioner for more than half of the Bush presidency, which is "not a healthy situation for any agency, and certainly not for one whose jurisdiction covers one-quarter of the nation's economy and touches on so many critical issues of public health," according to a Post editorial.
The editorial adds, "Also unhealthy are the suspicions -- which increasingly appear to have some grounding -- that the supposedly independent agency has been relentlessly politicized." The editorial concludes that Bush "should move quickly to nominate -- and the Senate should, after careful consideration, confirm -- a commissioner with staying power: someone the with scientific expertise, management abilities and strength of character to do one of the most important jobs in government" (Washington Post, 9/24).