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Introduction

In 1992, FDA Commissioner David Kessler concluded that

it is too great a burden for average Americans to make deci-

sions concerning their own health care.  He stated,

If members of our society were empowered to make

their own decisions . . . then the whole rationale

for the agency (FDA) would cease to exist. . . .

To argue that people ought to be able to choose

their own risks, that government should not inter-

vene . . . is to impose an unrealistic burden on

people.1

Kessler's statement makes clear his opinion about the

FDA's role in society and about the necessity for paternal-

istic government intervention.  In his view, the citizen has

no freedom to rely on medical advice from professionals of

his or her own choosing and to decide along with those

professionals which medicines and medical devices to use.

Only the government decides.

This study presents a proposal to do away with FDA's

monopoly over market access for medical devices and to re-

place it with third-party certification.  This solution to

the problems raised by FDA regulation will produce a market

with safe, effective devices and wide-open exchange of

information.  Proposed "reforms" of the FDA system, which

are described in this analysis, would leave the agency's

monopoly intact and continue FDA's power to restrict the

flow of information from manufacturer to consumer.

The Nature of the Problem

The FDA has become a bottleneck, delaying the introduc-

tion of new medical devices for up to three years and caus-

ing the deaths of thousands of Americans who are denied

access to these new devices.2  The basic problem with the

FDA can be stated with a simple example from statistical

theory.  FDA makes decisions about whether or not devices

are safe and effective, and two types of statistical errors

are possible:

· A Type I error occurs when a false hypothesis is ac-

cepted as true.  It results in an unsafe or ineffective

device being marketed.