Jane Henney

Newly appointed commissioner of the Food and Drug Administration (FDA), Jane Henney (Nature Med., 4, 262; 1998), has announced that "the discipline of science and a scientific approach must ground our decision–making," and has called for a strengthening of the agency's science base. Quite how this will be achieved is not certain. The move is likely in response to recent criticism suggesting that the agency has a poor research base.

Lobbyists representing industry and patients have criticized the delay and expense of the drug approval process, whereas, consumer watchdog groups claim that the FDA has allowed regulatory decisions to be driven by politics rather than public safety. Each year, the FDA is forced to retract its approval of some drugs and remove them from the market, or add warning labels to them.

Michael Friedman, Deputy Commissioner for Operations at the FDA, is naturally defensive: "[because] we never have all the information that we need to make a perfect decision, the agency must make the very best use of the data as it exists at that moment." Echoing Henney's position, he adds, "having the best scientists engaged leads to making the best decisions." Henney, the first woman to head the FDA and the first cancer specialist, was previously the vice president of the University of New Mexico Health Science Center.

Until now, scientists have not been evenly distributed among the FDA divisions. The Biologics division, for example, maintains a fully–fledged research facility on the campus of the National Institutes of Health, but no similar facility exists for the Drugs division. Henry Miller, a Fellow at Stanford University's Hoover Institution and the former head of the FDA's Biotechnology division, argues that Henney's push for more science at the agency therefore creates a dilemma: "If you think that research is an absolutely essential component of regulatory review and expertise, then it needs to be there for the people in Drugs. If it isn't necessary, then Biologics is maintaining a hugely expensive research enterprise that isn't needed."

Friedman concedes that the FDA, whose drug approval workload is increasing at a rate of 12 percent per year, has been unable to support as much science as it should. "FDA is the spigot through which this vast amount of new research is being applied, and the agency has been under tremendous pressures to discharge all of its responsibilities within a fixed budget ... one of the painful consequences has been insufficient investment in and attention to the scientific base of the agency," Friedman told Nature Medicine. A recent internal review concluded that the agency, which has an FY99 budget of approximately $1.1 billion, only completes 50–70 percent of its legally mandated duties on schedule, a fact that Friedman says reflects the shortage of resources.