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.
Editor's Note: We invite comments and request that they be civil and on-topic. We do not moderate or assume any responsibility for comments, which are owned by the readers who post them. Comments do not represent the views of Reason.com or Reason Foundation. We reserve the right to delete any comment for any reason at any time.
nfl jerseys|11.17.10 @ 1:17AM|#
nxdgdf
سهمي|12.11.10 @ 4:38PM|#
asgsagasgasg
قبلة الوداع|8.16.11 @ 7:38PM|#
thank u