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If, somehow, the FDA is required to accept standards

that seem to necessitate a change in philosophy, it can

still find a way to delay and obfuscate and slow down the

approval process.  Even in defiance of the law, that is

exactly the history of the FDA.59  There are a nearly infi-

nite number of margins along which agents of the FDA can

delay approval, even if it technically breaks the law or

neglects to follow executive orders.

The FDA's proponents can argue that the FDA is an inde-

pendent organization insulated from special interests.

Technically that is true, but the FDA gets its budget and

mandate from Congress, which resists few political pres-

sures.  Even if the FDA were staffed with public servants

with the purest motives, what they do depends on the money

and mandate imposed by Congress.  FDA standards cannot help

but reflect that congressional pressure.  Senator Tom Harkin

(D-Iowa) remarked, "The person who pays the piper calls the

tune,"60 referring to conflicts of interest that may arise

when manufacturers are allowed to pay independent reviewers.

But, today, the government pays the piper, and it dictates

how the FDA sets its performance standards.

The FDA's Trial of Third-Party Review May Doom Significant

Change of the Current System

The FDA's third-party certification pilot program may

actually limit the possibility for more far-reaching change.

In operation it resembles nothing more radical than a user-

fee program for devices.  The FDA retains its complete sway

over approval, and the FDA has handpicked the devices and

third parties so that no clinical and no or very little

protocol-establishing work will be done.

Some of the predictions made by potential third-party

reviewers in June 1996, before the program began, were

eerily borne out in comments a year later.  According to an

official from a firm that offers third-party review, review-

ing organizations have the capacity to, and want to, review

more complex devices.  As it is, the official says, firms

with good review resources are not interested in routine

"cookbook" reviews61 of simple devices, and firms that do

not have good review resources see the simple devices as a

market.62  The FDA and other interested parties are aware of

the limitations to the pilot program,63 but the attempts to

improve it are unlikely to succeed while the FDA maintains

its stranglehold on approval.

In practice, the FDA's trial program may block any

consideration of alternatives to the FDA's current monopoly.