Hazardous to Our Health? by Robert Higgs

Author:Robert Higgs
Language: eng
Format: epub
Tags: -
Publisher: Independent Institute
Published: 2015-12-18T16:00:00+00:00

4

FDA Regulation of Medical Devices

Robert Higgs

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.

—Keith Lurie, M.D.1

Since World War II, medical devices have become increasingly important in the practice of medicine for diagnosis, monitoring, and treatment. More than 6,000 types are currently used, and the various models and brands constitute a set with nearly 750,000 distinct elements (Goldfarb and Wolfberg 1992, 35).

The device industry in the United States has grown rapidly and now comprises some 13,000 (mostly small) firms employing about 280,000 workers. In 1993 the industry produced U.S. output valued at $43 billion, or 46 percent of world production. About 23 percent of the U.S. output was exported. The industry has been highly competitive internationally—it generated a trade surplus of $4.7 billion in 1993. Including the output produced in facilities operated abroad, American firms had a 52 percent share of the world market (HIMA 1994, 40, 59, 68, 153).

Despite this apparent flourishing, participants in the U.S. device business—producers, purchasers, medical practitioners, and the ultimate beneficiaries, the patients—are deeply troubled. More and more device firms are moving or considering moving their research and manufacturing facilities to Europe. Doctors, hospitals, and emergency medical services increasingly find that devices available elsewhere in the world are not available in the United States, and thousands of patients are suffering as a result.

The cause of these woes is evident: perplexing, costly, and time-consuming regulations promulgated and enforced by the FDA. An industry executive and former FDA official recently observed that “the pendulum may swing back eventually, but the pendulum at F.D.A. is more like a wrecking ball.”2

In this chapter I consider how regulation intended to protect the public and enhance its health has become a wrecking ball. I describe how the FDA has gained greater legislative authority and imposed more sweeping regulations. I document how the agency has responded, especially during the past five years, to the demands of its congressional overseers and to scandals and shocking disclosures prominently featured by the news media. I describe how the device industry has been affected under the regime of Commissioner of Food and Drugs David Kessler, who took office at the end of 1990 and immediately adopted a more aggressive enforcement strategy. Finally, I describe where FDA regulation of medical devices stands today, focusing on some outstanding problems in the form and implementation of the current rules and their effects on producers, practitioners, and patients.

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