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· A Type II error occurs when a true hypothesis is re-

jected as false.  It prevents or delays the entry of a

safe and effective device into the market.

The FDA focuses too much on preventing Type I errors.  That

is, the FDA spends too much time and too many resources

trying to prevent the introduction of devices that may later

prove to be unsafe or ineffective.  Consequently, the FDA

does not spend enough time and resources ensuring that safe

and effective devices are not locked out of the market.  The

result is that safe devices are subject to extremely long

and costly delays before they can be marketed.

The FDA behaves that way because it is a public agency

that answers to politicians, and Congress and the President

pass on the political pressure they feel to the agencies

under them.  Congress' actions have been described as fol-

lows:

First require that the FDA do the unwise or impos-

sible.  A few years later, ask the General Ac-

counting Office to tell you if FDA is doing the

unwise or impossible as instructed.  Express shock

and surprise when you learn that it is not.  Hold

hearings to pistol-whip FDA and industry in order

to support the passage of more unwise or impossi-

ble-to-implement legislation.3

Another FDA watcher describes how Congress turns agen-

cies into public scapegoats and whipping boys, creating and

maintaining the FDA's obsessive desire to minimize Type I

errors:

From FDA commissioner to the bureau heads to the

individual NDA [New Drug Application] reviewers,

the message is clear: if you approve a drug with

unanticipated side effects, both you and the agen-

cy will face the heat of newspaper headlines,

television coverage and congressional hearings.

On the other hand, if FDA insists on more and more

data from a manufacturer, and finally approves a

drug, which should have been on the market months

or years before, there is no such price to pay.

Drug lag's victims and their families will hardly

be complaining, because they won't know what hit

them. . . . They only know that there is nothing

their doctors can do for them.  From the stand-

point of . . . politics, they are invisible.4