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fants to breathe.  The FDA's action cost the lives of

10 to several hundred infants.9

· FDA action in 1992 halted production of Physio-Con-

trol's cardiac defibrillators for more than two years,

before allowing production to resume.  A defibrillation

authority, Dr. Richard Cummins, estimates "that FDA's

shutdown of Physio-Control might have caused a thousand

deaths."10

· "Balloon implants used to plug life-threatening holes

in brain arteries were rejected by the FDA because the

developers did not properly document their benefits.

Some neurosurgeons call the balloons `the world's stan-

dard of care.'"11

· Annually, 40,000 men undergo surgery to correct

benign prostate swelling.  An American-designed safe,

painless, permanent alternative--a tiny implantable

wire coil--was still not available in the United States

six months after its introduction in Europe.12

· Despite the clearly demonstrated safety and accuracy

of the home HIV test, FDA delayed its marketing for

five years.  As a result, an estimated 10,000 people

were infected with HIV because people who would have

used the test to find out that they were carriers of

the virus could not do so.13

These numbers reflect only some of the fatalities,

pain, and suffering that can be laid at the FDA's door.

Quality of life suffers when the FDA refuses to allow drugs

and medical devices to be sold until its exhausting, Byzan-

tine approval procedures are completed.  Vice President Al

Gore's National Performance Review proudly predicted that by

1997 new devices would receive final approval and be market-

ed within one year.14  Even had that goal been reached, the

FDA would have delayed access to the market for one year,

twice the time allowed in the law.  In the case of thrombo-

lytic therapy, that would have meant that only 11,000 people

would have died.

Taxpayers also bear a large, direct burden because of

the FDA.  The FDA is a monumental, costly enterprise funded

almost entirely by tax dollars (one exception is the FDA

program that permits drug manufacturers to make payments to

the FDA that are used to hire and keep additional drug

review and approval personnel at the agency).  The FDA

budget has hovered just below $1 billion annually since

1994.15