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.
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