Clinical Trials

Beating the FDA in Court


They say that whenever someone sued the FDA in the early '70s, Peter Barton Hutt, the FDA's chief counsel, would go into court and say, "The Food and Drug Administration is the expert scientific agency charged by the U.S. Congress and the president to protect the safety of pregnant women and small children." At that point, the case was effectively closed.

This story isn't true, but it might as well be. The FDA has been called "the agency that never loses." It almost never gets challenged, and when it does, it almost always wins. It's big. It's usually challenged on questions of fact and not on questions of law, which makes judges defer to it most of the time. It uses complicated words from science. It has the taxpayers paying its legal tab. It's going to be around for the rest of your company's life. And it never forgets.

There are two struggles going on for the soul of the FDA. The first is the debate over what the law should require the FDA to do, a debate that has intensified with Republican control of Congress. The FDA is consistently overconservative. It keeps life-saving drugs and medical devices out of the country and approves others only after interminable delays.

Tens of thousands of Americans die every year because they don't have access to the necessary medical technology. Consider the following estimates:

? Seven thousand people die every year because the FDA hasn't approved the Ambu CardioPump, a CPR device that is available in just about every other industrialized country.

? Nine hundred people die every year because the FDA hasn't approved the OmniCarbon heart valve, which also is in use just about everywhere else.

? From November 1988 to May 1992, about 3,500 kidney cancer patients died waiting for the FDA to approve the drug Interleukin-2, which was already available in France, Denmark, and seven other European countries.

? In 1988 alone, between 7,500 and 15,000 people died from gastric ulcers caused by aspirin and other nonsteroidal anti-inflammatory drugs, waiting for the FDA to approve misoprostol, which was already available in 43 countries.

? And 22,000 people died between 1985 and late 1987 waiting for streptokinase, the first drug that could be intravenously administered to reopen the blocked coronary arteries of heart-attack victims.

People may well come to the United States from other countries to take advantage of advanced surgical techniques and avoid waiting lists, but when it comes to things under FDA jurisdiction, like drugs and devices, it's Americans who travel abroad. The FDA's caution and delays are also driving many companies to other countries. From 1992 to 1994, for example, Medtronic, a major medical-device manufacturer, moved 12 new businesses or new product lines to Europe, including its $40 million corporate ventures R&D group. And the Irish Bio Tech News reports that Ireland is now home to more than 40 expatriate American medical-device companies, employing 8,500 people, and that 10 more American companies are building facilities in Ireland.

Forty-five percent of device manufacturers say they want to move abroad. Newt Gingrich has called the FDA the "number one job killer in America." Joel Nobel, president of ECRI, an independent medical-device testing company, predicted two years ago that "it is unlikely that it will take Congress and [FDA's Device Center] more than another five years to destroy much of the U.S. medical device industry." Since the Republican takeover of Congress promises tougher scrutiny of the agency, Nobel no longer urges device manufacturers to emigrate immediately. But he remains wary.

Nobel explains how Congress sets FDA medical-device policy: "The theoretical American patient, beloved by Congress and consumer advocates, that they wish to protect from an avaricious industry and uncaring health-care community is a wonderful abstraction beloved, as well, by the media. But real patients hurt, bleed, and die for many specific reasons, which manufacturers and the health community address in detail. Those details are not understood by Congress and the FDA, and political ideology keeps consumer advocates from seeing technical issues in perspective.

"To Congress we must say that our road to hell is paved with your good intentions and that we understand your formula. First, require that the FDA do the unwise or impossible. A few years later, ask the General Accounting Office to tell you if the FDA is doing the unwise or impossible as instructed. Express shock and surprise when you learn that it is not. Hold hearings to pistol-whip the FDA and industry in order to support the passage of more unwise or impossible-to-implement legislation. Do not forget to include testimony from patients whose demonstrable suffering can be attributed to the FDA and industry derelictions. Be sure to use a few exceptional industry sins to justify collective guilt and punishment. Never allow testimony by knowledgeable witnesses who may disagree with your preordained conclusions and already-written legislation, unless they represent industry and can be portrayed as self-serving and mercenary."

FDA partisans have a one-word answer to such criticisms: thalidomide. In the early 1960s, thousands of European babies whose mothers had taken the sedative thalidomide were born with birth defects. FDA enthusiasts claim that it was only thanks to Dr. Frances Kelsey of the FDA and her stubborn questioning that thalidomide stayed out of the United States. But what this really means is that the FDA was already powerful enough to stop potentially dangerous drugs. Since the thalidomide scare, however, FDA has grown more powerful—and more deadly.

In 1962, Congress passed the Kefauver-Harris Amendments to the Food, Drug, and Cosmetics Act, which required that the FDA test all drugs for efficacy, as well as safety, before approving them. In 1976, because of problems with the Dalkon Shield IUD, Congress passed the Medical Device Amendments. These effectively extended the same requirements to medical devices—a broad category covering everything from pacemakers to Band-Aids. In 1990, because of defective heart valves and controversy over silicone-gel breast implants, Congress passed the Safe Medical Devices Act, which further restricted medical devices. More legislation followed in 1992.

When a device or drug fails, an FDA regulator can count on hostile headlines, angry congressional hearings, and the threat of new legislation. But suppose a regulator is super-cautious and doesn't approve a life-saving device. What happens? Nothing. The heart-attack victims don't know that they could have been saved by streptokinase, and so the 22,000 deaths are invisible and safe. Sam Kazman, a public-interest attorney with the Competitive Enterprise Institute in Washington, dubs the problem "deadly overcaution" and calls the system "consistent with neither good government nor good science nor respect for individual liberty and dignity."

All this is, of course, disputed by FDA partisans. Fans of the FDA use two main arguments. The first goes something like this: "Those who claim that the FDA is doing a bad job take money from drug companies. Therefore, the FDA must be doing a good job." The second argument, recently made by Sidney Wolfe of Public Citizen Health Research Group, is that "the evidence for a lag in important drugs getting marketed here later than in other countries is extremely weak."

The first argument is stupid; the second is just wrong, and everyone in the drug and device industry knows it. Thankfully, these issues are now being discussed, after years of having been swept under the rug.

The second struggle for the soul of the FDA is waged in courtrooms by food and drug lawyers. Its goal is not to change the law, but to stop the FDA from breaking it. And by making the agency's decision-making processes public, these lawsuits can expose the FDA's vindictive, sloppy, and overreaching procedures.

Since 1990, when David Kessler took over as FDA commissioner, enforcement has been one of the FDA's top priorities. In his first two months, Kessler added 100 new criminal investigators to his enforcement staff, many of them formerly with the Secret Service and the Drug Enforcement Administration. Armed raids on alternative health clinics and dietary supplement dealers followed, as well as increased warning letters, product seizures, and criminal prosecutions in the drug and device industries.

"We're getting new regulations out faster than ever before," Kessler boasted immediately after the 1992 elections. "We rely much less on voluntary agreements, and much more on court-enforceable consent decrees."

Unfortunately, the FDA isn't virtuously ensuring public safety in accordance with the law. "As with most administrative agencies," says Glenn Lammi of the Washington Legal Foundation, a D.C.-based public-interest litigation group, "the agency constantly attempts to expand its jurisdiction and power, straining against the limits the law places upon its actions."

In his 1994 book, The FDA Follies, Herbert Burkholz tells the story of what happened to Barr Laboratories during the generic drug scandal of the 1980s. Edwin Cohen, the president of Barr, testified before a congressional subcommittee in 1989 about the arbitrary and unfair treatment he had received at the hands of the FDA—"retroactive decision making, shifting standards, procedural and substantive leaks, favoritism by a reviewer, and high-handed and arrogant treatment by FDA officials." Within hours, FDA inspectors were swarming over Barr's facilities. Barr repeatedly sued the FDA for relief from harassment. The FDA said it wanted to close Barr down and assiduously tried to for the next three years. The company was deluged with minor inspection violations and delays in drug approval. Its share price fell from $37.50 to $6.00. It had to stop production on several product lines and lay off 25 percent of its employees. And in 1993, Edwin Cohen was replaced by someone whose mission was to make peace with the FDA.

The lesson of Barr Laboratories is simple. Says Burkholz: "In matters of compliance, the FDA is supreme. If the agency says that the floor of your plant is dirty, then you'd better grab a mop and a broom, even if you know that it's pristine clean, because no court in the country will take your side." Or, as Joel Nobel says, "You are not paranoid. They are really out to get you."

The generic drug scandal is over, but the FDA is still around. And, according to Glenn Lammi, so are reasons to sue.

? Under the Food, Drug, and Cosmetic Act, new drugs have to be approved or rejected within 180 days. So do "Class III" medical devices—the most heavily regulated devices, including pacemakers. But we should be so lucky. Pre-market approval requests for Class III devices take an average of 840 days (up from 337 in 1988), and new drug applications are running at two and a half years. One hundred eighty days used to be a mandatory deadline. Now, it's a discretionary "goal"—no thanks to Congress, which has never even commented on the change, much less authorized it.

? Since 1991, medical-device distributors have been required to register with the FDA. Before then, only those who "manufactured, prepared, propagated, compounded, or processed" drugs and devices had to register and were subject to "Good Manufacturing Practices" requirements and mandatory inspections. But in 1991, the FDA decided that even though distributors aren't listed, they propagate devices and so they should register too. According to Lammi, to "propagate," in this context, probably means to create drugs or devices for sale. If Congress had meant to "distribute" it they would have said so; it did after all, refer to distributors elsewhere in the act.

? In 1990, the FDA decided to regulate liquid chemical germicides that are used to clean medical devices and health care products. Not only did the FDA do this without public comment, but a lot of those germicides were already being regulated by the EPA as pesticides.

Then there are those FDA procedures that aren't illegal but really ought to be. If you make medical devices, the FDA can fine you $15,000 per violation of the law, up to a total of $1 million. "Per violation" means that if you made a mistake on your label and you shipped 70 devices with that label on it, you've violated the law 70 times, which means that you have to pay the full $1 million.

Another quirk of this rule is that the judge who figures out how much you owe works for the FDA. Whoops! There goes independent, objective adjudication. The judge's ruling can only be appealed to a federal court if the judge acted "arbitrarily and capriciously," which is a tough standard to meet; it goes without saying that rules like these give the FDA a lot of clout.

The results of all this? More paperwork, more delay, more lost profits and lost jobs, more companies moving offshore to escape FDA regulation—and more patients without medical care. And unless people challenge the FDA, it will continue to infringe the legal rights of the industries it regulates and deprive consumers of good, cheap foods and drugs.

Every once in a while, people do fight back against the FDA. And every once in a longer while, some people win. The lesson from their experience is that given enough people with enough courage, money, and lawyers, the FDA can be kept in line and made to obey the law. At least for a time.

Take the case of R S Medical, makers of muscle stimulators called, appropriately, the RS-1 and the RS-2. R S Medical had been marketing the RS-1 and the RS-2 for five years, but when it made minor modifications to the products, the FDA tried to rescind its approval. R S Medical took the FDA to court; the agency agreed to let R S Medical continue marketing the products, as long as the company submitted another application.

But this time, the company played a little prank on the FDA. It submitted the applications in January 1992 and hired a consulting company to submit the same applications under different names—the BTM-100 and the BTM-200. The first application was submitted in February 1992 and the second in March 1992. In April, the FDA found that the BTM-100 was substantially equivalent to other stimulators on the market and allowed the consulting firm to sell the product. It did the same for the BTM-200 in July.

R S Medical wasn't so lucky. Its review process lasted a full year, until January 1993. The reviewers asked a lot of technical questions; the company answered them. The FDA declared that the RS-1 and RS-2 were not substantially equivalent to other muscle stimulators—for reasons unrelated to their previous questions—and denied the applications.

Ordinarily, you don't want to punch the traffic cop in the nose, but R S Medical did, and the court found "glaring evidence of arbitrary action" in the FDA's different treatment of the two companies. It was found that R S Medical's applications were rerouted; instead of going to the reviewers that normally look at muscle stimulator applications, they went to the same people at the FDA who had originally wanted to rescind R S Medical's approvals. The FDA also had conducted an unscheduled inspection of R S Medical—according to the court, hoping "to uncover some deficiency which could affect the safety and effectiveness of the RS-1 and RS-2." The district court entered a permanent injunction against FDA in December 1993. R S Medical also benefited from the Equal Access to Justice Act; this law allows small companies who sue the government to get their attorneys' fees reimbursed. R S Medical was awarded nearly $400,000 in fees.

Laerdal is another one of the shining examples of a company that beat the FDA on its own ground. Laerdal makes automatic external defibrillators, which are used to restart stopped hearts. In early 1993, the FDA charged Laerdal with many violations of "Good Manufacturing Practices" (GMPs) and a number of paperwork violations. GMPs are a set of quality-control standards (such as rules about how to handle complaints and keep quality-assurance records) that companies have to abide by if they don't want the FDA to close them down. GMPs are, in general, a good idea, but conformity with GMPs is not the same as good product performance. As ECRI's Nobel puts it, "There is no known relationship between GMP paperwork and actual product performance in the field."

The FDA's solution was to close the company down until all GMP problems were resolved. Laerdal denied everything and challenged the FDA to prove the allegations. It said it was willing to make any changes in procedures that the FDA wanted. In an effort to accommodate the FDA, the company kept improving its systems and adding enhancements from the time the suit was filed until the time the trial started. But it staunchly refused to shut down.

The resulting trial lasted three weeks and revealed that while the FDA might be effective at regulation, it's lousy at litigation. It makes the kind of tactical blunders one might expect from an agency that isn't used to being under scrutiny.

The FDA routinely asks for exhaustive documentation on minute details of company procedures. But the FDA itself isn't prepared for similar probes. At the time of the trial, there were only three companies making automatic external defibrillators (AEDs). Each defibrillator is estimated to save one life per year. It seems reasonable that the FDA would at least try to estimate the effect on the AED market of shutting Laerdal down. Well, it did try. Its idea of an economic impact statement was a memo—one which obviously was never supposed to see the light of day—saying that someone at the FDA called up a broker friend to get a sense of the market, and that the broker said it wouldn't be much of a problem.

The FDA is also used to having internal, confidential discussions with its own in-house experts. Normally, it doesn't have to reveal anything that goes on in such discussions. The FDA's stock response to outside requests is, "File a Freedom of Information Act request"—and a lot of information isn't available through FOIA. But during lawsuits, whatever goes on in conversations with expert witnesses has to be made known to the other side. The FDA didn't count on that. In fact, in the Laerdal case, the FDA even withdrew one of its expert witnesses rather than submit the agency to such scrutiny.

The judge found that the FDA had failed to make its case. The FDA couldn't prove any of the GMP violations. Not one of them. Not even for the procedures that Laerdal changed at the FDA's suggestion. Of all the paperwork violations, the judge found for the agency in only one case. That case is now under appeal by Laerdal. The FDA didn't even try to prove the charges. It expected the court to take its claims at face value.

The Laerdal case, one attorney told The Food and Drug Letter, an industry newsletter, makes clear that "the burden of proof is on the agency to demonstrate the existence of a violation for which the proposed remedy is appropriate….The agency took the approach of saying, 'We want you to show that you are in compliance,' instead of accepting the responsibility of demonstrating someone is out of compliance. They were saying, 'Would you kindly take a step into the quicksand we have ready for you here?' That is not acceptable."

Usually, the FDA gets away with shifting the burden of proof, because companies are afraid to fight the agency. Says Larry Pilot, an attorney at the law firm McKenna & Cuneo, which represented Laerdal: "Lord, [some companies will] sign a consent decree before they get a single bit of information from the FDA. They don't know what the FDA has on them."

Perhaps the strangest thing about the Laerdal case is the FDA's reaction. The FDA Center for Devices and Radiological Health came out with a report on its "accomplishments" for 1994. Under "Enforcement": "In a contested court action against Laerdal Manufacturing, the District Court judge ruled in favor of FDA in finding the firm failed to properly meet its [paperwork] requirements." That's the one charge which wasn't thrown out, in a case where the FDA started out by claiming that the defibrillators were unsafe and killed people. The FDA didn't contest the decision. It filed an appeal, but later withdrew it.

Peter Barton Hutt, once the FDA's chief counsel, has become a vocal critic of the agency. But he is pessimistic about the odds of beating the FDA in court. Successful cases, says Hutt, are flukes. "The judicial system, no matter what people say, is a lottery. You get a good judge or a bad judge, a good jury or a bad jury—it's totally unpredictable, like Russian roulette. The variability of the judges is infinitely more important than the 'validity' of the case. All of these decisions are so ad hoc that for anyone to draw lessons from them is a terrible mistake."

Except, Hutt corrects himself, for the one large lesson: "The odds of prevailing against FDA are small. If you believe in engaging in the lottery, you might want to litigate against the FDA too."

And, says Hutt, the agency holds grudges. No matter what happens—whether it wins or loses—it never forgets who its enemies are. "If you lose, you have an angry FDA which is willing to slit your throat. When the FDA loses a case, it has a mind like an elephant. It's just something you've got to understand about the FDA. Once the agency makes a collective decision, trying to make it let go is almost impossible. These are 'FDA crusades.' In a real sense, they're vendettas. They started a war in 1920 with the dietary supplement industry, and it's not over yet. The FDA decided that cyclamate was dangerous in 1969. Everyone knows it's not dangerous, but they still don't have the political courage to say, 'We made an honest mistake in 1969.' The FDA is institutionally incapable of doing that."

Still, suits can be good for consumers and manufacturers, if not for the original plaintiffs. Prominent food and drug attorney Jerry Heckman, of Keller & Heckman, tells the story of a landmark food-packaging case that was handed down in 1979. Food packaging usually doesn't get as much press as drugs and devices, partly because the FDA is a lot less of a problem with food packaging. But why is that? Part of the answer may lie in the tale of Monsanto v. Kennedy.

Monsanto had an unbreakable bottle made out of a material with a long name straight out of science—an acrylonitrile styrene copolymer. This was considered an extremely good bottle, and it might well have captured the soft drink market. Unfortunately, some bad data came out on the toxicity of acrylonitrile. Not the plastic, mind you, but the material that was used to make the plastic. The FDA issued a press release, saying in effect that it had made a mistake in approving the bottle. Coca-Cola, which was going to market products in the bottle, withdrew from the deal they'd made.

Monsanto sued the FDA, and the FDA took the second. The second law of thermodynamics, that is, which says, among other things, that substances diffuse over time, and so acrylonitrile will eventually get into your Coke. This means, said the agency, that acrylonitrile is a "food additive" and should be regulated under the 1958 Food Additives Amendment to the Food, Drug, and Cosmetics Act. Well, yeah, said Monsanto, but there was so little acrylonitrile that it could never be a problem.

Judge Harold Leventhal, who heard the case, called the second law of thermodynamics "a paradigm of technical information well understood by all scientists and practically no persons of the culture of humanism and letters." The first law is that whenever you say "acrylonitrile styrene copolymer," a judge's eyes glaze over. But in this case, Monsanto won. The court told the FDA that second law or no second law, food and drug law didn't prohibit teensy-weensy amounts of chemicals. FDA had to go back and reconsider their position.

As we know, when the FDA loses, the company doesn't always win; it took the FDA five years to reconsider. By then, the market for that plastic was gone in the U.S. because PET (that's "polyethylene terephthalate" for people of science) was now all the rage, though acrylonitrile is still being used for reusable bottles in Japan and Germany.

But Monsanto is a landmark case because it established that there's such a thing as a "reasonable expectation of no migration." In the decade following Monsanto, as analytical methods became more sensitive to minute quantities of chemicals, the FDA became more and more willing to say "this is so small that we don't care." In the end, both consumers and plastics companies came out ahead.

In 1993, the FDA came out with an official "threshold of regulation" policy for food packaging, which said the following: Suppose that your package contains a substance, but there's so little of it that it would only be one two-billionth of your diet. Or suppose that the substance is already regulated as a direct food additive, and your package would only add 1 percent of the recommended daily intake. Then, that substance is exempt from regulation as an indirect food additive. The 1993 thresholds of regulation were a large step for food packaging; Heckman, who represented Monsanto, calls them "unusually satisfying." And they wouldn't have been possible if Monsanto hadn't decided to sue the FDA.

In the final analysis, though, legal action is at best only a second-best solution. Even if all legal action were successful, all that lawsuits can do is make sure that the FDA follows the law. When the FDA does stupid things in violation of the law, litigation can keep it in line. But even if perfectly implemented, the law would give the FDA far too much power to restrict consumer choice and access to life-saving treatments.

The Laerdal case showed that if the FDA tries to shut a company down in an outrageous way, the FDA can be stopped. Shutting a company down in a run-of-the-mill way is still OK, though. Joel Nobel tells manufacturers: "If [the FDA Device Center] destroys a company and the livelihood of its employees, that is irrelevant to both the agency and Congress. The law does not require them to be concerned, and that argument, frequently made by industry, falls on deaf ears. Do not bother making it….The only way to get a response, either from Congress or the FDA, is to invoke public scorn, invective, ridicule, and sarcasm….I do not like this approach. It is rude and tasteless. But nothing else we have tried has ever worked. Lest you think this is a very private view, several [Device Center] insiders have confided to us that they think it is the only workable approach." One of the advantages of court cases is that, if properly publicized, they can evoke the appropriate scorn. But scorn is of limited value unless it leads to actual reform.

Reforming the FDA shouldn't be all that difficult. It's not as if we need to reinvent the wheel. Other countries have fine wheels already, and they roll more smoothly than ours. Here are a few examples from medical-device regulation.

In the United States, a device manufacturer has to send a pre-market notification to the FDA when it wants to market a new device. The pre-market notification, which the FDA quaintly calls a "510(k)," basically tells the FDA, "This device is substantially equivalent to a device that's already on the market, and I'm planning to market it in 90 days." (This system doesn't apply to the really risky devices, such as implantables.) Ninety days is the limit set by law, but the FDA stopped meeting that deadline in 1992. The average review time for a 510(k) is projected to exceed 300 days next year. Once upon a time, this would have been no problem, because when the 510(k) system was set up, you were free to market as long as the FDA didn't say no. But in 1990, the rules were changed; now, you can't market unless the FDA says yes. So despite the 90-day rule, review times have skyrocketed, companies have to wait unreasonably long times before they can market their products—and we don't even get a significant safety benefit out of it, since these aren't even risky devices.

In Canada, on the other hand, there is no "pre-market notification" system. They've got "post-market notification." You have until 10 days after you begin marketing to submit your application to the Canadian equivalent of the FDA. And they can't stop you unless they find something wrong with your product. The threat of having one's product pulled from the shelves is enough to keep device manufacturers in line—but the innocent, small device manufacturers can still get their products out.

There's another interesting thing about Canada—you can export from there. In the United States, the FDA has to grant an export license for you to be able to sell to another country—even if the other country has already approved your device. It gets even worse: In one recent case of regulatory imperialism, the FDA tried to seize "adulterated" mushrooms that hadn't cleared customs yet. Normally, when goods haven't cleared customs, the importer has the right to reexport them, whether or not they're misbranded. But an FDA district director said, "Where we believe there is a potential hazard to health, we don't want this stuff going anywhere." A federal judge in New Orleans nipped that one in the bud, though the FDA wants the case reconsidered.

Paul Geyer, a Canadian medical-device manufacturer, tells people to set up shop in Canada because "if the FDA walks into your place and says, 'We're shutting you down for X, Y, and Z reason,' you can't do anything; you can't ship to Europe; you're dead." If you're in Canada, the FDA can stop you from selling in the United States, but at least it can't stop you from selling elsewhere.

One of the main barriers to medical-device innovation in the United States is slow and unpredictable regulatory treatment. In Europe, things are faster, clearer, and more efficient. Medical devices have to abide by certain known, definite standards, which are based on the standards and practices of the industry. This is in contrast to the U.S. system, where companies have to abide by "Good Manufacturing Practices," which are made up by the FDA and subject to interpretation by the inspector. In Europe, if you conform to all of the standards, you can get a "CE" (Certified Europe) mark from any of a number of private or quasi-private certifying organizations called "notified bodies." Each country can designate its own notified bodies, such as the British Standards Institute. The European system has two distinct advantages. First, device manufacturers aren't subject to the whims of overzealous inspectors. And second, things go faster and more smoothly because "approvals" are handled by what are essentially competing FDAs.

The most important thing to do is to end the FDA's monopoly in drug and device approval. The FDA should keep reviewing drugs and devices (preferably farming the job out to these private certifying bodies), but only in an advisory capacity. Unapproved drugs and devices could carry warnings—a metaphorical skull-and-crossbones—but the final choice should be left to hospitals, doctors, and patients. Doctors, whose reputations and incomes are on the line, would still have an incentive to act responsibly, and so unapproved drugs and devices wouldn't be widely used—but they would be available for those in need.

Humorist Dave Barry tells the true story of the time federal law enforcement authorities cracked down on a shipment of frozen scallops. In October 1994, the marshal's office in Norfolk, Virginia, was ordered to arrest more than 6,400 pounds of sea scallops. Their offense? Containing between 85 percent and 87 percent water. Interim water content guidelines set by the FDA and the scallop industry set the maximum water content at 84 percent. On September 6, the U.S. attorney's office filed a civil lawsuit against the scallops in the U.S. District Court in Newport News, Virginia. The lawsuit's name: U.S.A. v. 268 Cases, More or Less, of an Article of Food. As Barry might say, I swear I am not making this up.

Due to their spineless nature ("as members of the deceased mollusk family," as Barry put it), the scallops chose not to challenge the FDA. But are we men or scallops?

Not that the FDA should be challenged lightly. As The Food & Drug Letter notes, "Dealing with FDA is a study in boundary recognition: knowing when to advance, when to retreat, when
to confront, when to tug the forelock." Tommy Thompson, chairman of the Medical Device Manufacturers' Association, warns, "Don't get the idea that we want to be belligerent. We say 'Yessir' just like anybody else." But as David Link, who was the first head of the FDA's Bureau of Medical Devices, reminds us: "You do not want to throw things back in FDA's face, but you do not want to get screwed, either."

There has probably never been as much hope of reforming the FDA as there is during this Congress. But the hopes of reformers have been dashed before. At a recent medical-device convention in Anaheim, California, "How to live with the FDA" and "How to leave the FDA" were the dominant themes. FDA representatives and other experts went into excruciating detail about how to prepare a 510(k), what exactly GMPs are, how to prepare for an inspection, why you should do exactly what the inspector says, and so on. Meanwhile, one session was entirely devoted to why manufacturers should emigrate to escape the clutches of the FDA and where they should go.

As for prospects of reform, FDA experts don't seem to be holding their breath. Commissioner Kessler may be the most popular government employee in Washington today, says writer James Dickinson of Medical Device & Diagnostic Industry. The naked truth may be that the American people want the FDA because they're scared of things they can see. Thalidomide babies are visible and make headlines, and people want to avoid that. Heart-disease patients who die because a drug wasn't available yet—these people, though more numerous, are invisible, and so people aren't too concerned with that. And people are still more comfortable with thinking of food and drug corporations as the enemy. The folks at the FDA are from the government; they're here to help us.

So the American people may be of limited help. And firms that appease the FDA, says one food and drug attorney, are only "nourishing the monster….Most companies do not want to fight the agency, even if they have a defensible position. By their reluctance to challenge, they are encouraging FDA to trample their rights. This will continue until some David decides that, if Goliath is going to kick his ass, he is going to have to do it."

Which means that for now, our best hope may be that in this litigious society, someone, somewhere, will decide to sue.

Alexander Volokh is an assistant policy analyst at the Reason Foundation.