I have recently written three reports on the U.S. Food and Drug Administration's regulation of medical devices that summarize and provide documentation for the views I hold regarding the U.S. regulatory system.(1-3) The following report will present eight conclusions I have reached, in the form of comparisons of the U.S. regulatory system with the corresponding systems in Europe, Canada, and Japan.
Here they are:
(1) During the past 30 years, medical device regulation in the United States has been driven mainly by political forces, especially by the reaction of members of Congress and FDA officials to shocking or scandalous revelations widely disseminated by the news media. Even without such revelations, however, the same political actors have worked relentlessly to increase the scope and detail of the regulations, the only exception being the Republican-led 104th Congress. So-called consumer advocates and investigative reporters have wielded considerable influence, demanding ever more regulation. Events highlighted by the media have provided apparent justification for new legislation or more aggressive regulatory enforcement.
Outside the United States, medical device regulation has been far less politicized; more nongovernmental input from scientists, engineers, and technicians has been heeded; and commercial incentives to harmonize regulations have been foremost in the minds of the architects of new regulations. “Consumerism” of the publicizing, lobbying, litigating sort familiar to Americans has played virtually no role.
(2) Medical device regulations in the United States have been formulated mainly by members of Congress, their staffs, and employees of FDA, with limited input from persons knowledgeable about scientific, technical, and economic conditions in the regulated industries. The result has been a form of regulation that apparently seems sensible to lawyers but often seems foolish and counterproductive to well-informed parties.
Outside the United States, the details of medical device regulation have been less the work of lawyers and more the product of persons having some acquaintance with the economics and technology of the regulated sector, especially the specialists in the standards organizations.
(3) Medical device regulators elsewhere wield authority over manufacturers that is far less discretionary than the authority wielded by FDA. In Europe and Japan, many low-risk products can gain approval on the strength of manufacturers’ declarations of compliance with established standards. In Europe, the Notified Bodies — -respected independent testing organizations, most in the private sector — perform the assessments of conformity with standards, not the government. Japan will soon operate similarly for nearly all approvals. Abroad, manufacturers know that certain established standards — usually those formulated by the International Standards Organization, the Comite European de Normalisation (CEN) or the Comite European de Normalisation Electrotechnique (CENELEC) — must govern their operations; they know, therefore, what they must do to market their products.
In the United States, in contrast, the regulatory requirements are a “moving target,” as individual FDA reviewers can and routinely do alter the specific requirements for product approval as the process unfolds, making repeated requests for more data or new kinds of information each time the applicant satisfies a particular demand. No matter what the company does, FDA may still withhold approval. On some occasions, political motives or bureaucratic desires to retaliate against insufficiently obsequious firms have clearly governed FDA’s decisions. To describe FDA as a “loose cannon” would suggest both its unpredictability and its capacity for destruction. Because Congress has enacted statutes delegating open-ended authority to the agency and the courts have tolerated its wide-ranging exercise of discretion, these departments of government bear even more fundamental responsibility than FDA itself for the extent to which the agency acts in an arbitrary and capricious manner.
(4) FDA’s medical device reporting system, authorized by the 1990 Safe Medical Devices Act, imposes major costs on reporting firms and user facilities and buries FDA under a mountain of data so vast that it cannot be entered into a data base in a timely manner, much less analyzed. This senseless approach to postmarket monitoring of product performance typifies the indifference of Congress and FDA to balancing the benefits of additional information collection against the costs.
In other countries, reporting requirements are much more modest and more often voluntary, yet there is no reason to believe that the patients of Europe, Canada, or Japan have suffered because too little information was available about product performance. Actual users of the equipment are better placed than bureaucrats in a central office to evaluate its performance and to sort out the contributions of user error, improper maintenance, and other factors unrelated to product design or manufacture.
Analysts fishing in oceans of data at FDA headquarters are especially susceptible to seizing on correlations that are in fact spurious. Worse, such oceans furnish fertile fishing grounds for scandal-mongering investigative reporters and so-called consumer advocates whose technical understanding is nil and whose ideological bias against the device manufacturers is enormous.
(5) During the past five years, FDA has markedly slowed the rate at which it approves new or improved products. Annual approvals of premarketing approval applications, on average, have fallen about 50% from the average for the previous eight years. No corresponding retardation of approvals has occurred elsewhere. Therefore, U.S. device manufacturers have been placed at a substantial disadvantage relative to their foreign competitors. The U.S. approval slowdown, partly a reaction to the hysteria about silicone breast implants, has added great costs, delays, and unpredictability to what was already a burdensome approval process. Worse, American patients have found themselves increasingly unable to get state-of-the-art treatments unless they are sufficiently wealthy and knowledgeable to obtain treatment abroad. Without a doubt, thousands of Americans have suffered and many have died because of this “device lag.”
(6) FDA enforcement authorities, who have long fancied themselves “cops,” became much more hostile, uncommunicative, and punitive during the early 1990s, as Commissioner of Food and Drugs David Kessler placed the highest priority on aggressive enforcement. People who work in the device companies, creating and distributing products of immense benefit to mankind, have been stunned that the authorities would treat them as suspected felons. To say that they have been demoralized would be too weak a statement.
Elsewhere the regulators bear no resemblance to the FDA cops. In Europe, the companies work with the Notified Bodies, who must deal with them fairly and cooperatively or risk losing business. In Japan, the personnel at the Medical Device Division are concerned that the Japanese medical device industry succeed and that the Japanese public gain access to improved products from foreign as well as domestic sources. Likewise, Canadian regulators have nothing like the reputation of FDA for hostility and vindictiveness.
By making itself the enemy of the device industry, FDA has necessarily made itself the enemy of the public health. After all, FDA does not invent, refine, produce, and distribute these life-saving and life-enhancing products. When FDA assaults the industry, it assaults the patients served by the industry.
(7) U.S. device firms have reacted to the more hostile regulatory environment of recent years in several ways. In some cases firms have simply abandoned product lines or R&D projects that, in light of the increased costs and uncertainties, no longer promised to be profitable. In other cases, the firms have transferred R&D, clinical trials, or manufacturing to Europe. Given that Europe itself was adopting more demanding regulations and that Europe during the early 1990s was enduring its worst recession since the 1930s, the relocation of U.S. device activities to Europe speaks volumes about the effects of FDA regulation on the U.S. device industry. The American economy has suffered and lost employment opportunities in a clean, high-tech industry with a strong comparative advantage in the world market. Worse, where projects have been delayed or abandoned altogether, future patients will suffer as a result.
(8) Despite the less stringent regulation of medical devices in Europe, Canada, and Japan, the people of those countries in general have not suffered substantial harm because of unsafe or ineffective products — at least, if they have, no one has reported that fact nor is any of the experts I have interviewed aware of it. Foreigners have definitely benefited, however, from their early access to the latest, most innovative devices.
Dr. Arthur Beall, Jr., a professor at the Baylor College of Medicine, could have been speaking for American physicians in general when he said: “It’s not a matter of our losing our edge. We have already lost it.” Beall added, “The question is, how many patients have I lost because I don’t have this
technology [already available in Europe]?” Echoing Beall, Dr. Keith Lurie of the University of Minnesota concluded: “We’re a year and a half behind the rest of the world, thanks to the FDA. We don’t get the ... equipment we need to save lives.”(4)
1. Higgs R. How FDA is causing a technological exodus: A comparative analysis of medical device regulation — United States, Europe, Canada, and Japan. Washington, DC, Competitive Enterprise Institute, February 1995.
2. Higgs R. Wrecking ball: FDA regulation of medical devices. Washington, DC, Cato Institute Policy Analysis No. 235, August 7, 1995.
3. Higgs R. FDA regulation of medical devices. Hazardous to our health? FDA regulation of health care products, R. Higgs (Ed.), Oakland, CA, Independent Institute, 1995, pp. 55-95.
4. Dr. Beal and Dr. Lurie as quoted by Hamburger T and Meyers M. Losing the edge. Minneapolis Star Tribune, June 26, 1994.
Dr. Higgs is research director for The Independent Institute, a public policy research and educational organization with headquarters in Oakland, California. His address is 714 Laurel Street, Edmonds, WA 98020
Originally published in the Medical Sentinel 1997;2(1):24-25. Copyright ©1997 Association of American Physicians and Surgeons.