Have you heard the one about how many commissioners it takes to run the US Food and Drug Administration (FDA)? The answer is “0.5,” according to the Bush administration. Not much of a joke, but a predictable punchline for a US government that prefers the comfort of convenience.
On 23 September, Lester Crawford, the newly appointed commissioner of the FDA, abruptly resigned after little more than two months at the post, and following more than a year as acting commissioner. Within days, President Bush had tapped family friend and head of the National Cancer Institute (NCI) Andrew von Eschenbach to act as the interim chief (p. 1128).
The White House is no stranger to accusations of cronyism. But the appointment of the head of the NCI as acting chief of the FDA either suggests that both positions are figureheads or reveals a lack of understanding of the aims of these two organizations and a disregard for the assurance of their independent scientific and apolitical governance.
Responding to concerns of possible conflicts of interest as head of both agencies and the full-time commitment required of both jobs, von Eschenbach announced that he would temporarily relinquish day-to-day management of the cancer agency and recuse himself from FDA matters involving the NCI. Health and Human Services Secretary Mike Leavitt appointed John Niederhuber, the NCI Deputy Director for Translational and Clinical Sciences, to manage daily operations at the NCI, but von Eschenbach retains the title of director. Whether that translates to active involvement in the direction of the NCI, while simultaneously heading the FDA, remains to be seen.
Either way, it leaves two influential US agencies lacking full-time committed and permanent leaders. Although day-to-day management at both may continue unperturbed, the problems that have plagued the FDA are unlikely to be resolved under an interim chief, and the immunity of the current appointment from political persuasion is questionable.
In December 2004, we noted that the FDA had been without a commissioner for all but 16 months of the previous four years. The position has now been occupied for a total of 18 months over the course of nearly five years. The continued absence of a commissioner willing to critically assess and correct the agency's shortcomings not only risks lives but damages the public trust in the FDA—and, by extension, in the integrity of medical research.
In the past, the interim leaders at the FDA have shied away from making major changes to the agency, a fact that has not gone unnoticed by critics. Concerns about the length of time required for drug approval, stringent regulations for initiating clinical trials and overly conservative decision-making have all been raised as arguments that the FDA needs to revamp its operations. Advocates of faster drug approval may find a friend in von Eschenbach who has stated that, in his new role at the FDA, he looks forward to participating in the rapid and safe delivery of medicines to the public. Not surprisingly, his appointment has been endorsed by some patient groups and pharmaceutical industry representatives. But von Eschenbach's comments echo the goal of the NCI to accelerate approval of new cancer drugs—he spearheaded a joint program with the FDA to help achieve this aim—and underscore the inherent conflict in his temporary new assignment.
On the other side of the coin are accusations that the FDA maintains too close a relationship with the pharmaceutical industry, approving too quickly drugs with unproven track records and reacting too slowly to problems that arise. Iressa was approved in 2003 under an accelerated program for drugs that treat serious or life-threatening illness. But it failed to improve survival in individuals with non–small cell lung cancer and is now restricted to individuals who have previously benefited from the drug. In this instance, the follow-up trials required under the 'fast-track' system permitted monitoring of the drug's efficacy in larger patient populations. This was not the case with Vioxx, which is estimated to have caused thousands of fatal heart attacks before its withdrawal from the market by Merck in 2004—a profound regulatory failure attributed in part to the lack of surveillance mechanisms for monitoring and reporting adverse side effects of approved drugs, and in part to the inaction of the FDA despite evidence of risk.
Charges of political interference also beleaguer the FDA, as in the recent deferral of decision-making on over-the-counter sales of Plan B, the morning-after pill, in spite of support of the application by FDA scientists. The deferral is widely attributed to a decision based on moral grounds, reflective of the White House views on contraception and abortion. Two FDA officials have since resigned in protest, including Director of the Office of Women's Health Susan Wood, and the issue has prompted an inquiry by the Government Accountability Office. Given his close ties to the Bush family, a negative decision on Plan B by von Eschenbach will only reinforce the perception of undue political influence on FDA decisions.
The FDA is in need of a strong leader able to withstand external pressures and to address head-on the problems brought to light in the wake of the Vioxx scandal, among others. von Eschenbach has the opportunity to make concrete and progressive recommendations to revitalize the FDA at a time when it has, unexpectedly, the attention of the administration. Or he can simply maintain the status quo until a new commissioner, one with both vision and fortitude, is selected. But would you give up your day job for that legacy?