Epstein on the FDA and Stem-Cell Treatments

Government Overreach Threatens Lives

Throughout its long history, the Federal Food and Drug Administration has insisted that its mission is “protecting and promoting your health.” Take that your seriously. In area after area, the record suggests that the paternalist FDA fails you in its announced purpose. Far from protecting “your health,” the FDA prevents you from making the informed decisions to preserve and promote your own health. All too often, the FDA lacks both the judgment and technical expertise to decide which treatments ordinary people may choose to undergo and which they must turn aside.

To take one example, the FDA’s critics have bemoaned its ignorance on such cutting-edge technologies as mobile health apps. Uncertain of its own footing, the FDA’s habitual regulatory caution drives away private investment from venture capital firms that know that millions of dollars in equity can disappear the instant the FDA issues a single adverse notice, which in practice can never be reversed by anyone else.

The FDA misfires at the outset by insisting that on matters of human health the correct approach is “better safe than sorry.” Like all rules of thumb, this one is at best a crude proxy for choosing your optimal risk bearing strategy. All too often, errors from delay can dwarf those from the hasty deployment of chancy technologies. Without any detailed knowledge of your relevant situation, the FDA has no idea whether you face a greater risk from going too fast or too slow.

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