Science & Technology: Regulators
"Incredibly Stressed" at the FDA
Can it meet new challenges on a 10-year-old budget?
Daniel L. Michels vividly remembers the unsavory discoveries he made when he was a field investigator for the Food & Drug Administration. There was the bakery equipment infested with an ecosystem of bugs, the ceiling plaster falling into cornmeal, the rat-urine trails running through the cocoa beans in a chocolate factory. Now director of enforcement in the FDA's Office of Regulatory Affairs, Michels believes similar things "are probably going on today." But no one knows. The FDA is so financially strapped that it manages to inspect most of the nation's 50,000 food plants about once every 10 years. "We don't have the time to do filth anymore," says Michels.
Filth is one of many areas where today's FDA is a shadow of its former self. One big and visible chunk of the agency--drug approvals--is thriving, thanks in part to fees paid by drugmakers. But FDA officials and outside experts agree much of the rest of the agency is falling on harder times, stretched thin by years of tight budgets. "FDA has become a have and have-not agency," says William K. Hubbard, the agency's policy chief. FDA officials say many programs have been reduced to a point where they barely exist.
A program that tests foods for pesticide residues now does 7,200 samples a year, down from over 20,000 in 1990. The staff regulating cosmetics has been cut in half since the early 1980s, making it impossible to search for possible contamination in plants or assess the long-term hazards of products. Nor is anyone inspecting products such as fancy olive oil to make sure they contain what the labels say. Overall, agency watchers fret the FDA is falling short in everything from analyzing drug injuries and deaths--now numbering in the hundreds of thousands a year--to inspecting a tidal wave of imported foods. And unless the agency steps up oversight of dietary supplements, "there will be a disaster someday," warns Dr. Steven H. Zeisel, chairman of nutrition at the University of North Carolina at Chapel Hill.
At the heart of the FDA's woes is simple mathematics. Over the past decade, the agency's budget of $1.14 billion has barely budged in real dollars. Yet at the same time, Congress has pushed through more than two dozen bills that give the agency expanded responsibilities, such as stronger oversight of medical devices. Meanwhile, the FDA has faced an explosion of new and challenging products--from gene therapies to druglike foods. And there are whole new ways of doing business that cry out for consideration, such as selling prescription drugs over the Internet. "We're strangling FDA to death," says Peter Barton Hutt, a Washington attorney and former FDA chief counsel.
Not everyone believes the situation is that dire. Critics in Congress and industry charge that the agency has been too quick to waste scarce dollars. "Under [former FDA Commissioner] David Kessler, so many of the agency's resources were directed at the tobacco initiative that everything else suffered," argues CEO John Cordaro of the Council for Responsible Nutrition, a dietary supplement trade group.
Regulated industries also wonder if FDA officials exaggerate the budget woes. Seafood companies, for instance, have complained that inspectors delay valuable shipments of shrimp and other foods to do analyses in the agency's Los Angeles lab. The FDA blames inadequate facilities, but "we feel at times they are just holding up shipments to put pressure on us to go to Congress and get money for the lab," says Richard E. Gutting Jr., executive vice-president of the National Fisheries Institute, a trade group.
Moreover, the agency is too timid when it comes to approving products such as food additives, says Kelly Johnston, a lobbyist for the National Food Processors Assn.: "All the resources in the world won't fix the problem if there's a culture of indecision."
But despite their skepticism, execs know they need a strong FDA. They even push for more resources because the FDA's stamp of approval on products is a crucial ingredient for winning consumer confidence and acceptance--and profits. Procter & Gamble Co. defended Olestra, its controversial fake fat, by pointing out that it had been through an exhaustive FDA review. Now, food-company execs blame Europe's flap over genetically modified crops in part on a failure by EU regulators to command the trust of consumers. Contrast this with the U.S. scene, where such products have caused far less concern. "The standards we set and the safety we ensure helps make business profitable," argues the FDA's Hubbard.FALLING SHORT. Industry representatives agree. So now that the FDA's capabilities--and possibly its future credibility--may be under threat, some industries are going to bat for the agency. When FDA officials claimed they had to cut $2.5 million from the office of cosmetics last year, "we went to Congress with an unusual argument for a trade association," says Michael J. Petrina of the Cosmetic, Toiletry, & Fragrance Assn. "We said, `Please restore funds so the FDA can continue to regulate us."' They got what they wanted. Similarly, the dietary-supplement industry is now asking the agency to require that companies meet so-called good manufacturing practice (GMP) rules. With supplements facing a host of critics, "we need to be able to say this is a well-regulated industry," says Cordaro.
Still, the FDA's oversight of these areas falls short of what most experts believe is needed. Dietary supplements are a case in point. At the agency's Center for Food Safety & Applied Nutrition, where the staff has shrunk by 20% over the past 20 years, "every program is struggling," says director Joseph A. Levitt. The supplements program is the worst off. A staff of 20 is trying to monitor a rapidly growing $12 billion industry that, according to a 1994 law, is allowed to sell anything it wants without checking first with regulators. If problems do arise, the FDA has to prove that products are unsafe before it can take action--a process that takes far too long. Over the past four years, for instance, the FDA has received hundreds of reports of "adverse" events associated with the supplement ephedra, which is consumed in herbal teas and extracts for a variety of ills, including asthma and colds. And there would probably have been far more reports if the FDA had a better-funded mechanism for spotting such problems. Yet the agency still has not managed to limit consumers' exposure to the harmful ingredient, ephedrine, which can cause high blood pressure, abnormal heart rhythms, and strokes.
No one predicts massive public health disasters will result from the FDA's budget plight. But the trend is worrisome. The FDA isn't as visible a cop on the beat as it should be, says Dennis E. Baker, associate commissioner for regulatory affairs: "There's always the potential, if we're not out there, that something can go wrong." Overall, the FDA has become "incredibly stressed, an agency that's not nearly as successful as people think it ought to be--with a potential effect on both consumers' health and business," says a top official.
When Congress finally finishes the fiscal 2000 budget, the FDA is likely to get, at best, only a modest increase. But unless lawmakers are a lot more generous, the safety net under the enormous range of products regulated by the FDA will inevitably begin to fray.By John Carey in WashingtonReturn to top