5 July 2016 - You may have heard that regulators in the United States are too strict when it comes to stem-cell treatments.

If not, then you will probably hear that message soon — patient groups, entrepreneurs and politicians are broadcasting it as they lobby for a change in the law. The FDA, this narrative asserts, is holding back effective therapies and, in the words of the most extreme, killing people by blocking their access to cures.

This is false. The claim that regulation is too harsh wrongly implies that the FDA is holding back therapies that work. Critics point to decades of preclinical and clinical work with stem cells and the pipelines of stem-cell treatments. With circular logic, they argue that, because the treatments have not been approved, there is something wrong with the approval system.

The assumption in these accusations — that these treatments work — is at the heart of the problem. The FDA is right to insist that only proper clinical trials can make that case. And the agency’s critics are right to point out that this process is lengthy and expensive — perhaps too much so.

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