The Food and Drug Administration discourages and prohibits medical devices that could save lives and ease suffering. The agency has always had an anti-innovation bias, but today's Cambrian Explosion of medical technologies increases the cost of that bias and limits the agency's ability to judge, evaluate, and control new devices.
Those seeking corrective measures usually round up the usual suspects: sleeker regulations, a revamped organization chart, and more taxpayer dollars. In contrast, my colleagues Richard Williams, Adam Thierer, and I believe the FDA is unfixable so long as it retains its current monopoly on device approvals. We would entrust the task of safeguarding medical devices' safety and efficacy to competing entities -- decentralized, privatized, and specialized -- at least for low- and medium-risk products. The European Union already has such a system.
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