Trokel's warning is neither speculation nor hyperbole. Vagueness and inconsistency are hallmarks of FDA eye laser policy. It doesn't take a refractive surgeon to recognize this, though many refractive surgeons have firsthand experience in the matter. Because small details change the most and are the hardest to get a handle on, the desire to regulate small details will lead to a constantly shifting legal regime, with FDA interpretations changing unpredictably based on ever-changing medical technology. Many doctors and manufacturers don't know whether they're covered by the law. Some doctors who feel their medical practice is being restricted by the software lockouts have taken to re-importing "gray market lasers"--lasers made by Summit and VISX for export, which neither require royalty keycards nor have the software lockout. Others, like Trevor Woodhams, have created "black box lasers" or "garage lasers"--basically, homemade lasers, constructed out of readily available components.
The FDA believes these lasers do not fall under the "custom device" exemption. "A custom device basically is a product made for use on one person," says the FDA's Snider, echoing the definition easily found in the Code of Federal Regulations, Title 21, Part 812, Section 3, Subsection (b)(5). Once you use the laser on multiple patients, she says, "there's no way that would be considered a custom device." Some doctors point out that since a laser's software must be reconfigured with the statistics of each patient, the devices--the hardware-plus-software combinations--really are individualized.
Woodhams, whose laser is under arrest, feels the FDA has treated him unfairly. He invested $350,000 in his laser and is still paying off the bank loans. Now he has to take his patients to an outside surgery center, which is inconvenient and requires him to pay the $250 royalty to Pillar Point Partners. The Summit and VISX lasers can treat a smaller range of conditions than Woodhams's own laser, which is why he built it in the first place. He had been getting customers turned away by other eye surgeons; now he, too, has to turn those customers away. The FDA enforcement action has doubled his costs per operation. "I felt like I was dealing in good faith in a gray area," he says. "I felt like they did not return the same good faith in their treatment of me."
Besides making unwitting criminals out of justifiably confused doctors, the irrationality of FDA policy encourages doctors and manufacturers to evade the law. Some surgeons have been buying lasers from unapproved manufacturers. On June 11, the FDA requested that U.S. marshals seize nine excimer lasers made by Photon Data of Winter Park, Florida. Surgeons were using Photon's lasers for PRK to treat nearsightedness. The offending equipment, which had a combined estimated value of more than $3 million, was seized at two Photon Data locations and at a private freight forwarder. Dr. Jui Teng Lin, the company's president, did not return my phone calls, but Woodhams, who knows of Lin's outfit, says Lin was building excimer lasers using the very newest technology, selling them to individual practitioners in the United States and abroad, and helping his domestic customers get investigational device approval from the FDA. "Personally," Woodhams says, "I don't think there was anything objectionable with what he was doing."
The FDA's Snider says neither Photon's nor Woodhams's lasers have been linked to any injuries, though the agency has received unsubstantiated reports of injuries related to laser eye surgery and is trying to learn more. In short, the FDA showed that it cares about hypothetical patients who might be hurt if the lasers remained in use, but it showed no consideration for the patients who could have been helped. The FDA did not show that it prevented harm, on balance, by seizing Photon's lasers, and the law does not require it to do so.
In a sense, what the FDA is trying to do now was contained in its mandate from the start. We just didn't know it at first, because limited technology made the scope of the FDA's power seem smaller than it really was. Now we know. As AEI's John Calfee puts it, "FDA regulation expands even when it seems to be standing still....It is now clear that in the absence of new legislation, the FDA of tomorrow will be more inclusive and more intrusive. To regulate more, the FDA does not need to expand its regulatory domain. It can preside over a spontaneous explosion in regulation, confident that expanding medical technology will move more and more of medical technology and medical practice into the boundaries of FDA regulation."
For years, both critics and supporters of the FDA have assumed that deregulation would reduce the agency's power. "Well, in our country," they figured, as Alice told the Red Queen in Through the Looking-Glass, "you'd generally get to somewhere else--if you ran very fast for a long while as we've been doing." The Red Queen's answer suggests the truth may be more complex than that: "A slow sort of country! Now, here, you see, it takes all the running you can do, to keep in the same place. If you want to get somewhere else, you must run at least twice as fast as that!" And so it is with FDA reform. The FDA must shrink just to stay the same size.
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