Moonlighting by acting FDA chief drawing stiff criticism

The Bush administration’s plan to allow acting Food and Drug Administration (FDA) Commissioner Andrew von Eschenbach to retain his position as director of the National Cancer Institute (NCI) is creating uneasiness among consumer advocates, cancer researchers and others who maintain that neither job can be handled on a part-time basis.

The Bush administration’s plan to allow acting Food and Drug Administration (FDA) Commissioner Andrew von Eschenbach to retain his position as director of the National Cancer Institute (NCI) is creating uneasiness among consumer advocates, cancer researchers and others who maintain that neither job can be handled on a part-time basis.

“He has 100 percent commitment to both those jobs” and will be supported by “great leadership teams” at both agencies, said Department of Health and Human Services spokeswoman Christina Pearson.

Others aren’t as sure. “They are both huge jobs,” said Jane Henney, who ran the FDA from 1998 to 2001 and was deputy director of the NCI from 1980 to 1985. “The FDA and the role of commissioner is huge, it’s demanding, it’s persistent,” Henney said. “I think it’ll be difficult for even the most able” person to juggle both, she added.

The FDA has lacked a Senate-confirmed commissioner for the majority of the Bush administration. Administration critics have charged that the absence of permanent leadership indicates that the agency is a low priority for the White House even as the FDA and the industries it regulates have drawn increasingly negative attention.

The White House named von Eschenbach as acting FDA commissioner Friday soon after the surprise resignation of Lester Crawford — who had just been confirmed in July — for reasons that have yet to become clear. Von Eschenbach has run the NCI, a part of the National Institutes of Health, since 2002. The Philadelphia native and longtime Texas resident oversees a $4.8 billion budget.

In a letter sent to White House Chief of Staff Andrew Card yesterday, Sen. Chuck Grassley (R-Iowa), an FDA watchdog, assailed the administration’s plan to put von Eschenbach in charge of two agencies.

Senate Health, Education, Labor and Pensions Committee Chairman Mike Enzi (R-Wyo.), who has oversight responsibility for the FDA, expressed eagerness to work with the White House to find a permanent FDA chief. A spokesman said he could not comment about von Eschenbach’s dual roles.

Von Eschenbach’s part-time commitment “reflects the low regard in which the Bush administration holds the FDA,” said Peter Lurie, deputy director of the health-research group at Public Citizen, a frequent administration critic.

Consumers Union Senior Policy Analyst Bill Vaughan remarked, “We know that the FDA is a full-time job and thought NCI was.”

The drug industry is not bothered by a part-time commissioner. “If the president has confidence in Dr. von Eschenbach’s ability to do both jobs, we do too,” Pharmaceutical Research and Manufacturers of America (PhRMA) Senior Vice President Ken Johnson said in a statement yesterday.

Nevertheless, Monday’s statement by PhRMA President Billy Tauzin hinted at the industry’s preference for a permanent commissioner. Von Eschenbach’s taking the helm “will allow the agency to continue its important work until a new commissioner is nominated and confirmed,” the statement reads.

The FDA has been besieged by criticism for its recent record on drug safety, the pace of its drug and medical-device approval process and allegations from Democrats that political considerations have trumped scientific evidence as the administration continues to postpone a ruling on whether an emergency contraceptive drug, Plan B, should be available without a prescription.

During the run-up to Crawford’s confirmation vote, he became the focal point of that criticism.

“Andy von Eschenbach will be in the same tough position that Dr. Crawford was,” predicted John Mendelsohn, president of the M.D. Anderson Cancer Center in Houston, where he worked with the new FDA chief. Von Eschenbach worked at M.D. Anderson for more than 25 years before taking over at the NCI.

Issues such as emergency contraception are ethical and political and “have nothing to do with science,” Mendelsohn said. Part of the job of FDA commissioner is implementing administration policies, he emphasized. “That’s something [von Eschenbach] will have to live with,” Mendelsohn said.

“He’s equipped to think about these things publicly” if he is allowed to, he added.

In a memo Monday to the NCI’s advisory committees, von Eschenbach emphasized that his appointment to the FDA is an “interim role” intended “to ensure an orderly transition of a new, permanent leadership at the FDA.”