Since World War II, medical devices have become increasingly important in the practice of medicine for diagnosis, monitoring, and therapy. Devices such as pacemakers, cardiac replacement valves, artificial joints, CAT scanners, defibrillators, and thousands of others have revolutionized medical practice.
Despite the diversity of regulatory regimes in the United States, Europe, Canada, and Japan, it is clear that no country has regulated medical devices as extensively or as rigidly as the United States. It is also clear that despite the less stringent regulation of medical devices in Europe, Canada, and Japan, the people of those countries in general have not suffered because of unsafe or ineffective products. In the words of Jim Phillips, vice president at Clarus Medical Systems, “It’s not that [these countries] don’t have standards. They do. They have specs and you can design by them. The FDA has no specs. It’s a black hole.”
Medical device regulators elsewhere wield authority over manufacturers that is far less discretionary than the authority wielded by FDA. Respected independent testing organizations in Europse, known as “Notified Bodies,” perform the assessments of conformity with standards. Additionally, manufacturers abroad know that certain established standards must govern their operations.
In contrast, the process in the United States is arbitrary and capricious; individual reviewers can and routinely do alter the requirements for product approval as the process unfolds. No matter what the company does, FDA may still withhold approval for any reason, or without a reason. Given FDA’s unpredictability and its capacity for destruction, the agency can aptly be described as a “loose cannon”.
During the past three to four years, FDA has accepted fewer premarket approval (PMA) and 501(k) (for devices “substantially similar” to some on the market) applications. In the same time period, the average review time for PMAs and 501(k)s increased from 150 days in the late 1980’s to 900 days in 1994, in spite of the fact that the FDA is required to rule on them within 90 days. The buildup of a huge backlog of 701(k) applications in 1992 and 1993 led bewildered applicants to speak of a “black hole” and an “eternal limbo”.
No corresponding retardation of approvals has occurred elsewhere. Therefore, U.S. device manufacturers have been placed at a substantial disadvantage relative to competitors in other countries. The U.S. approval slowdown has added great costs, delays, and unpredictability to what was already a relatively cumbersome approval process.
Without doubt thousands of Americans have suffered and died because of this “device lag.” However, foreigners have definitely benefitted from their early access to the latest, most innovative devices. Dr. Michael Werner, an American surgeon, observed, “I don’t know who [FDA officials] are protecting. Sometimes you wonder.”
FDA enforcement authorities, who have long fancied themselves “cops,” have become much more hostile, uncommunicative, and punitive during the past four years, as Commissioner Kessler has given the highest priority to aggressive enforcement. Compliance officials promoted a philosophy of “act now, talk later.”
FDA has failed to clarify for companies precisely what actions constitute compliance. In contrast, in Europe the companies work with the Notified Bodies, who must deal with them fairly and cooperatively or risk losing business. By making itself the sworn enemy of the device industry, FDA has necessarily made itself the enemy of public health.
Because of the more hostile regulatory environment, U.S. firms have reacted by abandoning product lines or R&D projects, or by transferring work to Europe. Grant Heidrich of the Mayfield Fund says, “We counsel our companies, ‘don’t screw around with the FDA; let’s move these trials to Europe where there’s a reasonable process.’” Said Rob Michiels, president of Interventional Technologies, “By the time we’re approved in the U.S., that product will have been available in Europe on the free market for three to four years.” Numerous surveys have also indicated the growing trend toward relocating research, development, and clinical trials abroad.
In sum, as Dr. Keith Lurie of the University of Minnesota noted, “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.” FDA’s policies are, for Americans, a public health problem.