Warning: cutting the FDA could be hazardous to your health.

It was the first time Don Vasbinder had seen a body in a bag of cocoa beans. In late 1993, inspectors from the Food and Drug Administration (FDA) sniffed something wrong in a shipment of beans from Brazil. Inside, they found a rotting corpse. "That was a first for me," says Vasbinder, the director of imports for the Baltimore distinct office of the FDA. "But the old-time food inspectors say that's not uncommon. In fact, they found another body shortly thereafter in Philadelphia."

If Vasbinder, a slight man with big block glasses and a Ph.D. in chemistry, is unfazed by this story, it's because in his 20 years with the FDA he has seen just about everything. Rusted surgical knives. Rotted mud fish from Singapore. Condoms with holes in them. And those are just the imports. Including the multi-billion dollar domestic market in pharmaceuticals, medical devices, and food, the FDA regulates products that account for 25 cents of every dollar spent in this country. A tour of FDA facilities in Baltimore, where scores of inspectors and scientists are only a small part of the 9,000-person, $980 million agency, yields a quick understanding of the FDA's importance: In the pesticide group, chemists have found dangerous levels of DDT in grain intended for breakfast cereal. In the drug lab, chemists have caught at-home tests for pregnancy and glucose that do not work as claimed. Stories of impure food and drugs--laced with unsafe chemicals, insect parts, rusted metal, even cigarette butts--are common.

Of course, as inspector Dean Cook points out while we walk through a spice plant filled to the roof with sacks of cola nuts, black pepper, and oregano, the vast majority of the goods he checks are safe. Reviewers of drugs and medical devices at FDA headquarters in Rockville, Maryland also attest that most manufactures want to make money by producing good products, not by scanning the system. But it is equally obvious that bad apples (so to speak) abound, both in this country and abroad. Keeping the food supply clean and the marketplace of drugs and medical devices safe and effective often takes more than a strong sense of smell. With chemical compounds and complicated medical devices, it takes years of careful study.

It is this studiousness and circumspection that rankle the agency's critics. In Congress, the same coalition that slashed the budget of the Environmental Protection Agency and pushed a moratorium on all new federal regulations is setting its sights on the FDA. It's a matter of jobs, Newt Gingrich explains, arguing that FDA overregulation is squelching industry and stifling economic growth. Shortly after his inauguration as speaker, Gingrich called the FDA the country's "leading job killer." And in a recent speech before health insurers, he said that in "phase three" of his revolution, "Maybe we'll take out FDA."

At Gingrich's flank is a cadre of conservative activists in Washington. The Washington Legal Foundation is running ads in major newspapers proclaiming "If a murderer kills you, it's homicide.... If FDA kills you, it's merely being cautious." The Progress and Freedom Foundation is proposing that drug and device approval be farmed out to private research groups or universities. Sam Kazman of the Competitive Enterprise Institute would remove the FDA's "monopoly," meaning that the agency would continue to operate but couldn't keep goods off the market. These groups happen to receive generous donations from the pharmaceutical and medical device industry as well as tobacco companies frightened of the FDA's proposal to regulate cigarette marketing to children. The FDA has always been controversial. Industry lobbied hard against the original Food and Drug Act in 1906, and the agency has been granted more power only when scandals shocked Congress into action. In 1996, though, the agency's waters are particularly choppy. Besides Republican hostility, the FDA also faces pressure to move more quickly from liberals in Congress such as Representative Ron Wyden and Senator Barbara Mukulski.

With the FDA's very existence called into question, you might expect the Washington press corps, congressional auditors, and the executive branch to be scrambling to evaluate the agency. In what way are the critics correct? What are the FDA's strong suits? What is the agency trying to do--and what is it actually doing where the rubber meets the road (or where the tablet meets the mouth)?

In a town often scandalously blithe about matters vital to the lives of Americans, the FDA has gotten no such treatment. The watchdogs are napping. if they woke up, they'd find an agency with a clear mission, dedicated staff and leadership, and the best safety record and reputation of any health agency in the world--an agency that is often wrongly maligned. The FDA isn't perfect, and its imperfections aren't pretty. But only through tough, fair scrutiny and analysis, of which this piece is a modest effort, can it be improved.

Drugstore Cowboys

The purpose of a business is simple: to provide a desired good or service and make a profit. In government, purpose is sometimes more difficult to discern. What is an agency's mission? In what way does it improve citizens' lives?

FDA Commissioner David Kessler sums up the FDA's mission in three words: "safeguarding America's health." More specifically, the FDA ensures the safety of the nation's supply of food, drugs, medical devices, and other health-related material, such as cosmetics, devices that emit radiation (like TVs and microwaves), and the blood supply. With drugs and devices, the FDA goes one step further and checks to make sure products work for the purpose claimed by the manufacturer. The logic is simple: While protections against egregious fraud are important in any industry, ineffective health-care products pose a particular risk. If a lamp doesn't work, you can take it back to the store and buy another one. But a pacemaker that doesn't work could kill you.

The clear sense of mission--the knowledge that their work can literally be the difference between life and death--infuses the agency with energy. The, FDA has way more than its share of bright, dedicated, competent people," says William Vodra, who worked for the agency's general counsel in the 1970s. "We would have discussions all the time, and ultimately someone would ask: 'Okay, what's in the public interest here?' On Capitol Hill, you never hear issues framed that way." Even critics, like Richard Samp of the Washington Legal Foundation, praise FDA staffers. "I'm generally impressed by their intelligence and public spiritedness," Samp says. "These people don't sit around dawdling in their offices, turning around paperwork all day."

In addition to the widespread acclaim for FDA employees, the agency's basic mission is affirmed by supporters and critics alike. Gingrich's blustering aside, there is widespread agreement that the FDA should remain, in Samp's words, "a centralized government bureaucracy providing an official stamp of approval that a product is certified as safe, based on the best available technology."

The issue with the FDA, then, is not what it should do--the question is how it does what it does. Like all regulatory agencies, the FDA faces the challenge of protecting the public without suffocating commerce. With drugs and medical devices, it faces an additional, more delicate, task: The FDA must protect the public from hazards without holding up useful treatments--keeping a life-saving drug off the market can be as lethal as allowing a flawed drug to go forward.

The famous case of Dr. Frances Kelsey illustrates the tricky business of regulating health products. Between 1959 and 1961, thousands of babies in 20 countries were born with grieyous deformities because their mothers had taken a new sedative called thalidomide during pregnancy. In the United States, the drug had never been marketed because Kelsey, the medical officer in charge of the application, had held it up.

Clearly, Kelsey made a huge save. And conscientious work like hers has made FDA approval the worldwide "gold-standard" for medical products. According to a study by Dr. Sidney Wolfe at the Health Research Group of Public Citizen, this country only had to recall 9 drugs between 1970 and 1992. Over that same period in France there were 31 recalls; in Germany, 30; in Britain, 23. But Kelsey's legacy has another side: According to close watchers of the FDA, she was known for being slow and ponderous--sometimes to excess. We know about the tragedy she stopped. But could she have caused a tragedy by scuttling beneficial new therapies? That question cuts to the heart of the FDA.

Among critics, it is an article of faith that the FDA is slow and getting slower. A commonly-cited Tufts University study shows that the average time required to bring new medicines to market in this country has increased from about eight to 15 years since the early 1960s. It's true that the FDA can be guilty of excessive caution, particularly when keeping a product off the market because they're not 100 percent sure it works. Reviewers have an incentive to err on the side of caution: If they let a bad drug get through, they face a rain of humiliation. If a good drug is stopped or unduly delayed, the only complaints come from industry.

Still, in context, the data cited by critics do not indicate an agency in crisis. Every decade or so, a defective medical product slaps Americans in the face and reminds this country of the necessity of thorough reviews. In 1962, it was thalidomide--which, along with earlier scandals, led Congress to require the FDA to check for the efficacy as well as the, safety of drugs. In 1976, it was the Dalkon Shield--an intrauterine device that caused 18 deaths and 66,000 miscarriages and led to FDA regulation of medical devices. In the late eighties came another series of scandals involving heart valves, jaw implants, and breast implants, among others. The resulting clampdown on devices led to a backlog in the early 1990s.

The Tufts study is not inaccurate; it does take longer to develop a drug now than in 1960. But the FDA rightfully is being more cautious than it was in 1960. It is also crucial when assessing the FDA's speed to distinguish between drugs and devices that truly improve on existing therapies, and those that replicate other products or add the chemical or engineering equivalent of a new bell or whistle. "If you're a drug company," explains Sidney Wolfe, and you see a lucrative $4 billion market for a drug that treats arthritis and it's nothing really new, but you can repackage it as something radically new, then you've going to go for it." According to the London journal SCRIP, of 47 new chemical entities introduced in the world between January 1 and December 8, 1994, only two were breakthroughs. Both were first approved and marketed in the United States. Remember the drugs recalled in Europe but never introduced here? Not one had shown a significant advance over existing therapies. In other words, it's not safe to assume that holing up a drug or medical device means lost lives.

But some FDA-regulated products are breakthroughs. The challenge for the agency, then, is to maximize its speed without sacrificing its standards. And according to a recent GAO report, the agency actually has made great strides in its review speed. hi 1987, the average review time for a New Drug Application--submitted after a drug has been fully tested in human subjects--took an average of 33 months; in 1992, the average was 19 months. This study also found the FDA to be quicker than the British Medicines Control Agency, to which critics often unfavorably compare the FDA.

When it comes to reviewing products that are, in fact, significant advances, the FDA has a good history; it has even improved in recent years. The agency correctly employs triage--assigning priority to products depending on the seriousness of the illness to be treated and the availability of other therapies. AZT, one of the few drugs available to fight AIDS and FHV, was approved in just a few months. Much of the improvement in review times is due to the institution of user fees for drug applications. Just as college applicants pay a fee to have their applications reviewed, drug companies now pay to have their data analyzed and methods reviewed. The FDA uses the funds to augment its staff, which leads to a quicker turnaround time.

Certainly the FDA could improve. It has, for example, a lackluster history with generic drugs, which are radically less expensive than patented drugs and can save consumers thousands of dollars in drug costs. With exploding health-care costs, it makes sense to push generics through as fast as possible. But for years, the pharmaceutical industry pressured the FDA to preserve the industry's competitive edge by holding up generics. The agency obliged, insisting, for example, that a generic undergo the same testing as a new drug, even though it might be identical to a drug already on the market. That practice was changed in 1985, when generics accounted for only 14 percent of prescriptions written. Today, they account for 45 percent, and the FDA now allows generics on the market the day a patent expires. But Congress hasn't granted the agency the authority to charge user fees to test generic drugs, and so it has insufficient resources to review them; that means useful and more affordable generics aren't making it onto the market. Whether though user fees or standard appropriation, FDA's budget needs to match its responsibilities.

And unlike its stellar record on safety, the FDA's record regulating product efficacy--something it's been doing only since 1962--is spotty. Too often, the agency takes an all-or-nothing approach: A drug is either fully approved for safety and efficacy, or it is kept out of patients' hands entirely. Once a breakthrough drug has been proven safe, there's no reason why people shouldn't be able to use it--assuming they're fully informed that the FDA has yet to certify the drug's effectiveness. Along these same lines, compassionate use--exemption from FDA rules due to a clear and pressing need--should also be expanded. Denying dying patients a drug because it might hurt them is clearly a fool's bargain.

On the whole, though, the FDA's record on drug reviews is good. The story with medical devices is somewhat more complicated. Rhetorical fireworks from agency critics have largely centered around devices, in part due to the fact that, unlike drugs, devices tend to be made by small entrepreneurs. A "no" from the FDA--or a delay in approval--can mean the end of a company.

Some of the critics' claims have legitimacy, but many do not. The Sensor Pad, intended to help women detect breast cancer, is an example of critics gone away. FDA "ineptness," the Washington Legal Foundation claimed in ads run in USA Today and Roll Call, "is still killing thousands of women .. The FDA has obstructed approval--for nine years--of the Sensor Pad.... In Canada, the product was approved in less than 60 days."

In fact, the best evidence indicates that the Sensor Pad is no more helpful in detecting lumps in breasts than bare hands and soapy water. The device was once marketed in Canada but ordered withdrawn by officials who echoed the concerns of the FDA: that the product could actually be less effective than traditional methods and might lull women at risk into a sense of complacency. To blame the FDA for thousands of breast cancer deaths, then, is the height of irresponsibility.

But the critics have a point about another device featured in Washington Legal Foundation ads and used by Gingrich as a prop to attack the agency: the CardioPump. An aid for paramedics conducting CPR on victims of cardiac arrest, the pump is sold legally in a dozen countries, including Japan and Germany; in Austria, it is standard equipment on ambulances. Even though many health professionals are convinced that the CardioPump is a valuable, life-saving tool, the FDA has kept the product off-market. The agency defends its decision by pointing to studies showing that, while patients treated with CardioPump do in fact reach the hospital in greater numbers than a control group, they do not survive at a higher rate. Unlike the Sensor Pad, however, there is absolutely no evidence that people will suffer from the Cardio-Pump's use. Given that the pump certainly isn't harmful, why not leave the decision to paramedics and hospitals after warning them that the FDA is not convinced of its efficacy?

But if less regulation is required with some devices, other areas show a need for more regulation, specifically the thousands of products that were "grandfathered" into approval. That means they went on the market before the FDA began regulating devices in 1976 and were subsequently granted a reprieve until the agency could get around to checking them. In many cases, they still haven't gotten around to it, and consumer advocates rightly complain about the slow pace. Some types of pacemakers grandfathered into approval, for example, have a 25 percent failure rate. It's a glaring loophole in an otherwise tough regulatory scheme.

The Food We Eat

Early last February, the makers of Similac infant formula were flooded with calls from frantic parents in Southern California. The formula had produced rashes, stomach aches, and seizures in 54 infants. The FDA staked out warehouses, searched dumpsters, and eventually caught two men selling fake Similac to supermarkets. Within weeks, the fake formula was confiscated.

Such heroic FDA stories are not uncommon, and it's not just consumers who benefit. Just ask Pepsi Co. In 1993, when the FDA exposed as a hoax claims that syringes had been slipped into Pepsi, the company saved the millions it would have cost to recall and dispose of its product.

Yet much of the FDA's work is rarely noticed, let alone shone on by the klieg lights of press conferences. That's partly because their life-saving work is so prosaic in appearance: At the FDA district office in Baltimore, I watched inspectors matter-of-factly sniff black tiger shrimp from Thailand--that's "organoleptic testing"--and scientists quietly testing baby corn and crab meat for botulism.

But while much of the FDA's work is admirable and underappreciated, the federal regulation of the food supply does need improvement. Spread across three agencies, it is often poorly coordinated. The FDA splits food regulation with the Department of Agriculture, which regulates meat, poultry, and some types of dairy products. The Environmental Protection Agency sets the rules for pesticides, and the FDA enforces them. The Department of Transportation even gets in on the act, setting standards for refrigerated vehicles.

With the resources it has, the FDA does a good job. But the resources are inadequate--and the jury-rigged nature of food regulation is a prime culprit. Take the recently-announced FDA rules on seafood inspection. One hundred and fourteen thousand Americans are poisoned by seafood each year; yet seafood regulations have changed little since the turn of the century. So it is a welcome sign that the FDA has finally overcome pressure from the seafood industry and imposed a new system of lab checks and computer monitoring.

But, believe it or not, the system will actually bring a decrease in inspections. That's because the new system is so complicated that it will double the average inspection time, but the FDA doesn't plan to put any new inspectors on the job.

And the shortage of inspectors isn't confined to seafood. FDA food inspections dropped precipitously from 20,528 in 1981 to 5,741 in 1994. The consequences are alarming: Raw oysters kill at least a dozen people each year, but the FDA has not responded to the problem. Last year in Florida, the Norwalk virus in oysters caused 121 illnesses, but there was no FDA recall. "The reality is," says Caroline Smith DeWaal, director of food safety for the Center for Science in the Public Interest, "they don't have inspectors, and they don't have a program adequate to meet the problem. With the pressure to approve drugs faster, it's only getting worse."

Why would pressure to approve drugs more quickly mean less regulation of food? Because the FDA has to do both jobs with only a limited fund pool. While Congress has piled on mandates for the FDA in monitoring drugs and devices, the blood supply, and medical procedures, lawmakers have made far fewer demands with respect to food safety. And so, with a total budget that is now stagnating in real terms--the agency received no increase for inflation in 1996 appropriations--the FDA has been forced to shift resources away from food. The $220 million the FDA spends on food regulation is only 40 percent of what the Agriculture Department spends on meat and poultry regulation alone.

Even with its comparatively enormous budget, of course, the Agriculture Department does not inspire confidence that it can keep tainted beef out of Americans' mouths. But the FDA shouldn't have to reduce resources on food inspections in order to increase resources on medical products--nor would taxpayers want it to. One sensible solution is to separate the regulation of food and drugs and devices into different agencies. If the FDA does keep all its jobs, Congress needs to make sure the agency is adequately funded for all its responsibilities.

Questions Still Unanswered

One magazine article can hardly cover all the important ground at the FDA. Consider the early testing of drugs on humans. Before a drug or device is even submitted to the FDA for approval, the "sponsor" has to go through a long series of tests. This is where most of the expense and delay in getting drugs from the laboratory to the pharmacist's shelf happens. How can these tests be done more quickly and at lower cost, and what can the FDA do to streamline the process?

The agency's actions in areas outside its traditional role of regulating food and medical products also need evaluation. Take cigarettes, for example. David Kessler is a hero for facing up to the tobacco companies. But is his agency the most sensible place to conduct such regulation? It seems more appropriate for the agencies responsible for fighting drug abuse--who now deal almost exclusively with illegal drugs--to spend some of their $14 billion annual appropriation curbing the abuse and youth-oriented marketing of cigarettes and alcohol.

Then there's an issue thrust into the limelight by Gingrich. Is the FDA hurting job growth in this country? Since his office would not provide evidence to back up his claim that the FDA was a "job killer," it seems the speaker may be on shakier ground than he might wish the public to believe.

Drug companies allege that the FDA has gotten slower and more bureaucratic since the thalidomide scandal of the early sixties--hurting their bottom line. So why is the stock of industry giant Merck & Co. 113 times more valuable now than it was in 1962 (in figures not adjusted for inflation)? Investors in drug stocks haven't just done well, they've done very well. Consider the story of Anne Scheiber, reported recently in The Washington Post. She bought $10,000 worth of shares in Schering-Plough Corp. in 1950. Today, that investment is worth $7.5 million. The industry as a whole has also done quite nicely. In 1980, non-generic drug firms had $12 billion in U.S. sales--a figure that exploded in the next 15 years to $57 billion.

Yes, American pharmaceutical and biotech companies are opening some operations overseas, but it is difficult to tell to what extent, if any, FDA regulations are to blame. Fruit of the Loom is moving overseas, too, but not because of excessive underwear regulation. And it isn't just the drug industry that's booming. A recent report in The Wall Street Journal showed that Swiss firms are rushing to invest billions of dollars in American biotechnology. "It is in the U.S.," Ralph King reports, "where the biotechnology industry began and, for the most part, remains."

Some other criticisms are as dubious as the notion that the FDA drives American industry overseas. "The problem with health care in America today is the FDA," the Washington Legal Foundation claims in its ads. If the FDA is the problem, one wonders if the tally of 41 million uninsured Americans makes the group's top five? Other critics don't seem to share the basic values that undergird the FDA's existence. Henry Miller, a former FDA official, recently blasted the agency in a National Review article as slow and politically-motivated. But when I asked him about the study showing France and Britain with triple the number of drug recalls as the U.S., Miller replied that he wouldn't mind more recalls if it meant getting drugs through more quickly. Considering the devastation that a bad drug can cause--Clometacin was withdrawn in France after 130 reports of hepatitis, including nine deaths; Indgmethacin-R was withdrawn in Britain after 717 adverse reactions and 36 deaths-this is hardly a trade-off most of us would like to make. This is not to demonize the agency's critics. The FDA's job is important enough--and the balance between getting good drugs on the market while keeping bad ones off is delicate enough--that vigorous criticism of the agency should be welcomed, not dismissed out of hand. Still, it hardly benefits the public to have the conversation dominated, and too often distorted, by a right-wing fringe. When confusion reigns, groups in the know, such as the regulated industry and big-money donors to Congress, benefit. And the public suffers.

Enhancing public understanding of the FDA should be a top priority of government auditors, the press, and the FDA itself. As it is, the only way a major review can get started is for a high official to pressure the GAO or the inspector general at the Department of Health and Human Services. Such reviews are rare. More common is the confusion that characterizes debates over the CardioPump and Sensor Pad. Critics accuse the agency of stonewalling; the FDA responds that it's doing a good job. The truth is hard to discern.

What's needed at the FDA is a strong, generously funded inspections office, which at the request of industry or Congress or interested citizens could review the handling of a particular case, produce an explanation in clear language as to what happened, and recommend future action. This would both educate the public and inject a sense of accountability into the FDA's review process. And since government reports can get buried, the press is an even more important engine for honest and constructive evaluations of the agency.

In this heated political climate, tough, fair scrutiny of the FDA is more necessary than ever. Think about it: When you brush your teeth in the morning, you know your gums won't turn black. When you take pain medicine at night, you can be confident that you won't get hurt--and that you haven't been ripped off. You can eat your meals without worrying about salmonella or a surprise serving of rat droppings. We take all these things for granted. We can't afford to do the same with the agency that makes that possible.