Missing in action
With no one at the wheel, the FDA has been conspicuously voiceless during the health crisis
Tucked away in her 17th-floor office at the Food and Drug Administration, Andrea Meyerhoff puts in 14-hour days running the agency's antiterrorism program. One moment it's safeguarding food, the next it's the blood supply--or ensuring the availability of medications. But beyond the walls of the FDA, few are aware of her efforts or that the FDA even has such an office. "Is the FDA gearing up?" asks Wayne Pines, a former associate commissioner. "There is no one coming forward to speak to the public about these issues."
The reason for that is simple: Ten months into the Bush administration, the FDA still has no commissioner. And while some drug-industry chiefs might prefer a leaderless FDA--the White House seems comfortable having stationed there a chief counsel whose opinions align with industry's on several key issues--the fact remains that the agency has no real boss. "The time when it is most important to have an FDA commissioner is a time of crisis because the FDA is often charged with making critical decisions," says William Schultz, a former deputy commissioner for policy at the agency.
Since the anthrax crisis began, Health and Human Services Secretary Tommy Thompson, the former governor of Wisconsin, and Anthony Fauci, an infectious-disease specialist at the National Institutes of Health, have been filling the void. And last week, HHS announced the creation of an Office of Public Health Preparedness to improve communication with health agencies and the public. But experts say the lack of an authoritative voice from the FDA remains significant. Although it was the agency's initiative to include doxycycline and penicillin along with Cipro as antianthrax agents, the message was delivered by Thompson, who is not a doctor. And when questions arose about Bayer's ability to produce enough Cipro, the FDA was not to be seen. U.S. News has learned that FDA officials were not even at the table when Thompson met recently with drug companies to discuss the development of important drugs and vaccines. "The FDA commissioner should be part of the inner circle of advisers working with the [Centers for Disease Control and Prevention] and the NIH in ensuring that the secretary can make decisions based on the best evidence," says former FDA Commissioner David Kessler. "This is vital." (The NIH is also without a director.)
Timing. The lack of a commissioner can be traced back to a year ago September, when the FDA approved RU-486, the controversial abortion drug. Antiabortion Bush supporters hoped that the decision could be reversed--safety issues would be the vehicle--and Thompson himself testified that he would review safety concerns "on that drug" during his confirmation hearings.
Candidates for the FDA job, who ranged from drug-industry executives to physicians and academics, were asked their views on RU-486. One former candidate says the White House wanted to know "how I would deal with tough issues" such as stem cells and questions of safety regarding RU-486. "I told them I thought all new drugs should be monitored carefully and that was just another one." Schultz believes the administration created false hopes of an RU-486 overturn. "There isn't any basis in the law for the FDA to reverse that decision other than science," he says. "It isn't a policy issue." Further complicating the matter was Sen. Ted Kennedy's announcement in July that his health committee would not approve anyone with ties to industry. Last month, Michael Astrue, an executive at Transkaryotic Therapies Inc. in Cambridge, Mass., withdrew from consideration after learning that Kennedy would oppose him.
The job isn't likely to be filled soon. Thompson's favored pick, Lester Crawford, who is the director of the Virginia Tech Center for Food and Nutrition Policy in Alexandria, is a veterinarian by training. Will that do? "The recent events have underscored the fact that the job requires someone with significant public-health experience," Kessler says. "It is essential."
This story appears in the November 19, 2001 print edition of U.S. News & World Report.