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access will not change that.

There is, of course, no reason to forbid the FDA to

continue in its current role but without its monopoly.  It

could compete with private certifiers and manufacturers, and

consumers could rely on an "FDA mark" as their chosen stan-

dard for safety and effectiveness.  Other manufacturers,

health professionals, and consumers might prefer other

marks.  Given the record of the FDA, that would be no sur-

prise.  The question is not whether devices would be certi-

fied, but which organization should certify them.

Conclusion

The U.S. Congress needs to turn over the FDA review and

approval of medical devices to independent, privately funded

institutions.

Legislation has given the FDA a virtual monopoly over

the marketing of medical devices, and political pressure

forces the FDA to place too much emphasis on preventing the

marketing of unsafe and ineffective devices.  In doing so,

the FDA permanently blocks or delays for years the marketing

of safe and effective devices, some of which would save

lives if they were available on the market.  The cost of FDA

regulation of medical devices is higher medical prices, and,

more important, unnecessary deaths and suffering.

Reforming FDA processes is not the solution.  The

reform proposals discussed in Congress have centered on

bringing efficiency and accountability to the FDA.  They

have been designed to force the FDA to adapt to the increas-

ing pace of innovation and the demands of American consum-

ers.  Yet the best efforts of congressional and agency

reformers fall short.  The sad fact is that the reforms

insulate the FDA from the market in important ways.  The FDA

has powerful incentives to drag its feet and request ever

more information, delaying approval while people suffer and

die.  It will continue to demand more information rather

than see its power diminish.  It will minimize the risk of

approving an unsafe device, at virtually any cost, for fear

of congressional repercussions.  What is most important is

that the FDA retains the power to enforce its decisions.

The reforms leave intact the FDA's power to prevent new

devices from entering the market.

There is an alternative to reform: abandon the current

regulatory process and embrace the free market that has

worked so well for so long in other fields.