Clinical Trials

Beating the FDA in Court

Alexander Volokh from the May 1995 issue

(Page 5 of 5)

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 Can-ada, 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 De-vice 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.