Friday, January 26, 2024

The world would not run amuck in the absence of the FDA

See Surgery is Not FDA Regulated by Alex Tabarrok. 

"What would happen if the FDA regulated pharmaceuticals much less than currently? I have pointed to one useful comparison, new uses of old drugs do not have to go through FDA required efficacy trials in the new use. In other words, new uses of old drugs are regulated for safety-only. Thus,
“off-label prescribing” provides a window on to what a world of safety-only FDA regulation would look like. Off-label prescribing surely results in errors and problems but overall physicians tell us that off-label prescribing is highly beneficial and critical to good medical care.

Maxwell Tabarrok points to another useful comparison, surgery. Surgery is not FDA regulated, despite having many of the same asymmetric information problems as pharmaceuticals. Some surgical procedures are surely ineffective and unsafe. Yet, once again, the FDA-absent surgery market appears beneficial overall and like other markets it improves over time with greater safety and more efficacy. For example,

In the US, the death rate from medical and surgical care complications declined by 39% from 1999 to 2009.

Would we be better off if every new surgical procedure had to go through FDA-required efficacy trials before it could be offered to consumers?

Neither of these comparison proves that a world with less FDA regulation would be a better world but both refute the stories of a world run amuck in the absence of the FDA. In essence, the reason is that the world contains many sources of approval, recommendation, certification and review beyond the FDA and these would grow in scope and stature absent the FDA.

See Maximum Progress for more."

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