Tumult at FDA: Crawford Leaves, von Eschenbach Arrives

September 29, 2005

ePT--the Electronic Newsletter of Pharmaceutical Technology

Tumult at FDA: Crawford Leaves, von Eschenbach Arrives

US Food and Drug Administration (Rockville, MD) Commissioner Lester M. Crawford resigned abruptly late last Friday, Sept. 23, after only two months in the top spot, generating considerable uncertainty about the future leadership of the agency. The White House immediately named Andrew C. von Eschenbach, MD, director of the National Cancer Institute (NCI) at the National Institutes of Health (NIH), as acting FDA commissioner. Von Eschenbach said he would continue as NCI director while taking the helm of FDA, a situation that may not be sustainable for very long without undermining operations at both NCI and FDA.

von Eschenbach has little familiarity with the many complex and critical issues that face FDA, but he may be a reasonable choice to head the agency. He is well known among cancer researchers. He was an executive at the M.D. Anderson Cancer Center (Houston, TX) before coming to NCI in 2002. His Texas connections are a plus for the Bush administration, and he has passed through the Senate confirmation process in moving to NCI. James Greenwood, president of the Biotechnology Industry Organization (Washington, DC), applauded the administration’s speedy appointment of someone with “unique insights into the critical need to advance new treatments for patients with life-threatening illnesses.” Cancer patient groups offer similar praise, but some parties consider him more interested in making headlines than bringing about real change: at NCI he set a goal of making cancer a manageable disease by 2015, which has been termed optimistic at best, and unrealistic by many observers.

At FDA, von Eschenbach must deal with many of the issues that plagued Crawford and delayed his confirmation by the Senate last spring. Because Crawford had served as acting or deputy commissioner during the past five years, he could not escape responsibility for the drug safety issues surrounding the “Vioxx“ (Merck & Co., Whitehouse Station, NJ) debacle, last year’s flu vaccine shortage, or the agency’s delay in approving broader access to the emergency contraceptive pill, “Plan B” (Barr Labs, Pomona, NY). The legislators finally approved him for the top job in July, but not unanimously.

A veterinarian and food safety expert-and not a medical doctor-Crawford had difficulty articulating the risks as well as the benefits of prescription drugs and advocating for continued speedy approval of new medicines. He lost support within the agency for some unpopular personnel decisions and for continuing to delay approval of Barr’s application to switch Plan B to over-the-counter status, even after pledging to make a decision on the issue by Sept. 1. A senior FDA official resigned over Crawford’s refusal to follow the scientific evidence supporting the Barr application, reflecting escalating discontent throughout the agency’s rank and file.

The New York Times reported that Crawford family members attributed his resignation to an unintentional omission on the financial disclosure forms he submitted as part of the confirmation process earlier this year.

Although administration officials hinted of personal financial problems as the immediate cause of Crawford’s departure, the White House appeared content to let him go. Conflict-of-interest charges would only further undermine Crawford’s ability to lead FDA at a time when the agency requires a leader with strong medical and scientific credentials who can restore public trust in the troubled agency that has long been regarded as the gold standard in the pharmaceutical regulatory world.

It may take months for the White House to appoint and the Senate to confirm a permanent FDA commissioner. In the meantime, controversial issues such as regulating follow-on biologics and strengthening drug safety oversight may remain in limbo, along with efforts to address the many scientific issues that stymie new drug development.

–Jill Wechsler