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Friday, May 4, 2012

The FDA Is the Problem, Not Its Budget

The FDA Is the Problem, Not Its Budget:
The Wall Street Journal recently ran an op-ed by a former commissioner of the FDA on the agency’s impact on medical innovations such as stem cell therapy (a subject we’ve blogged about at length). The author, Andrew von Eschenbach, boils down the FDA’s dousing of innovation to one major problem: lack of funding.
But the problem is the FDA itself, not its current budget.
The FDA has no business coercively keeping drugs, devices and other therapies off the market before it deems them worthy. By what right does the FDA force innovative companies like Regenerative Sciences to take a “time out” on the procedure they spent years developing and testing so that the FDA can play catch-up to the new technology? By what right does the FDA make it illegal for Americans to use their own cells until bureaucrats give permission?
The FDA, by its nature, treats innovators as guilty until proven innocent—what’s a bigger extinguisher of innovation, in terms of the costs and time involved for gaining regulatory approval, than that? And the FDA forces the rest of us to abide by its collective edicts, rather than our own doctors’ assessment of risks and benefits in our own, individual medical circumstances.
According to Eschenbach, “Regulatory approval is the only bridge between miracles in the laboratory and lifesaving treatments.” It’s time to dismantle that bridge and establish a system by which the government puts on trial only cases of demonstrable fraud, not all promising therapies.