Following the abrupt, unexplained resignation of the chief of the US Food and Drug Administration (FDA), observers are concerned that the crisis-ridden agency is being thrust into yet another prolonged period without permanent leadership.

Despite the quick appointment of an interim commissioner—Andrew von Eschenbach, chief of the US National Cancer Institute (NCI)—the $1.9 billion FDA could find itself adrift indefinitely while the White House remains preoccupied with disasters, wars and gas prices, they say.

The agency really does need to have permanent leadership in this time of great turmoil. Geoffrey Porges, pharmaceutical analyst

“The agency really does need to have permanent leadership in this time of great turmoil,” says Geoffery Porges, a former Merck executive and New York–based pharmaceutical analyst.

The FDA, which regulates roughly one-quarter of the US consumer economy, has been without a confirmed commissioner for more than three of President Bush's nearly five years in office. During that period, the agency has had to weather some particularly rocky times, including controversies about the side effects of antidepressants and painkillers and manufacturing deficiencies in flu vaccines.

Finding a permanent new commissioner could take months or even years. Mark McClellan, the first Bush appointee, didn't take charge of the agency until November 2002—two years after Bush was elected. After McClellan left in March 2004, interim commissioner Lester Crawford was not confirmed for 16 months.

“Unless the [Bush] administration makes filling this critical position a priority, there may not be a commissioner for who knows how long,” says William Schultz, the FDA's deputy commissioner for policy in the 1990s.

Initial speculation that von Eschenbach might become permanent commissioner was quashed in early October by Michael Leavitt, the Health and Human Services Secretary. “Andy is acting commissioner, and I suspect that will be his status until we fill it permanently,” Leavitt said.

Crawford's resignation on 23 September, just two months after his Senate approval, took Washington by surprise. Within hours, the White House announced that von Eschenbach, a Bush family friend (Nat. Med. 8, 7; 2002), would take over as interim commissioner—but remain at the helm of the NCI.

After critics protested that the dual role could constitute a conflict of interest, von Eschenbach said he would step down from his daily duties at the NCI and recuse himself from most NCI-related matters, such as drug and device approvals, at the FDA.

In the meantime, observers continue to speculate on the reasons for Crawford's resignation. One persistent report suggests that he failed to adequately disclose his financial interests to the Senate. Six days after his resignation, the committee that oversees the FDA launched an investigation into the circumstances surrounding his departure.