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Page 43

Third-party certification promises safe and effective

devices--quickly and efficiently--and gives consumers the

freedom to choose the amount of risk that best suits them.

The market provides consumers with the full remedies and

protections of our legal system, and it frees businesses

from the crippling costs of undue regulation.

The solution is for Congress to reject mere reform of

an unwieldy and dangerous agency and to consider the alter-

native--turning the certification of medical devices over to

the free market.

Notes

The author acknowledges the assistance of Cato interns--

Craig Farnham, Matthew Brown, and Clay McFaden--in the

preparation of this Policy Analysis.

1.  Robert Goldberg, "The Kessler Legacy at the FDA," IPI

Insights, January-February 1997, p. 1.

2.  Mike Meyers, "Doctor Went to Japan for Treatment He

Couldn't Receive in America," Minneapolis Star Tribune, June

26, 1994, p. 14A.

3.  Alexander Volokh, "Clinical Trials--Beating the FDA in

Court," Reason, May 1995, p. 24.

4.  Sam Kazman, "Deadly Overcaution: FDA's Drug Approval

Process," Journal of Regulation and Social Costs #1, no. 1

(August 1990): 43.

5.

Ibid., p. 44.

6.

Volokh, p. 23.

7.  Kazman, p. 43.  The fatality figures are calculated by

multiplying the length of time required to approve the new

drug application by the number of lives the FDA claims the

therapy will save.

8.

Volokh, p. 23.