Can the FDA Heal Itself?

Like any government agency that has been around for almost a century, the U.S. Food and Drug Administration (FDA) has endured its share of rough patches. But "rough patch" hardly begins to describe all the bad news that has battered the agency over the past few months, from the possible suicide risks with antidepressants like Prozac, Paxil and Zoloft to the cardiac risks of pain-killers like Vioxx, Celebrex and Bextra. Americans depend on the FDA to carefully weigh the benefits and risks of all drugs before approving them, but the agency has had trouble lately shaking the growing perception, justified or not, that it has been working harder protecting the pharmaceutical industry than the public it's supposed to serve.

The pressure for action grew so intense by last week that the FDA was forced to take action. On the eve of an extraordinary three-day hearing to air grievances resulting from the Vioxx and Celebrex snafu, it announced plans to create a new safety board to monitor drugs for unexpected side effects that show up after the drugs have gone on sale. Meanwhile, the Bush Administration finally moved to fill a one-year power vacuum at the top of the organization by nominating its acting chief, Dr. Lester Crawford, to be the FDA's permanent head.

Crawford wasted no time signaling a change in direction. "Our culture is not to alarm the public," he told employees at a department briefing, referring to the agency's practice of keeping mum about apparent side effects until they have been scientifically confirmed. "That era has passed. What the public is demanding is to know as soon as we know."

So far, however, the flurry of activity has done little to mollify critics both outside the agency and within. "I think the FDA is beginning to admit, in sort of a halting and hesitating fashion, that it hasn't done a good job with drug safety," says Dr. David Graham, the associate director for science and medicine in the agency's Office of Drug Safety and its chief whistle-blower. Graham calls the latest changes "cosmetic." An FDA official counters, saying they are "significant" and promise to have "a profound impact."

Democrats in Congress argue that the latest dustups show that the FDA needs more regulatory power and a bigger budget to stand up to the pharmaceutical industry. But the most aggressive attacks have come from a Republican, Iowa Senator Chuck Grassley, 71, chairman of the Senate Finance Committee. Normally the FDA would be the province of the Senate Health Committee, which usually has to approve any changes at the agency. But Grassley, whose state has many elderly constituents, has focused on the FDA for a year--ever since he learned that the agency held close to its chest worrisome data suggesting that certain antidepressant drugs might increase a teenager's risk of suicide. Grassley plans to introduce a bill next month that would create a new Office of Drug Safety independent of the FDA department that approves drugs.

"We've seen some evidence over the last year that the agency has been too cozy with drugmakers," Grassley says. An independent safety board, he argues, would ensure that the experts who are responsible for finding and publicizing unexpected side effects are not the same ones who originally gave the drug a clean bill of health.