MCViewPoint

Opinion from a Libertarian ViewPoint

FDA Policies Kill – LewRockwell

Posted by M. C. on November 27, 2019

https://www.lewrockwell.com/2018/12/walter-e-williams/fda-policies-kill/

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Among the U.S. Food and Drug Administration’s responsibilities are approval and regulation of pharmaceutical drugs. In short, its responsibility is to ensure the safety and effectiveness of drugs. In the performance of this task, FDA officials can make two types of errors — statistically known as the type I error and type II error. With respect to the FDA, a type I error is the rejection or delayed approval of a drug that is safe and effective — erring on the side of over-caution — and a type II error is the approval of a drug that has unanticipated dangerous side effects, or erring on the side of under-caution.

Let’s examine the incentives of FDA officials. If FDA officials err on the side of under-caution and approve a drug that has unanticipated dangerous side effects, the victims of their mistake will be highly visible. There may be congressional hearings, embarrassment to the agency and officials fired.

It’s an entirely different story if FDA officials err on the side of over-caution and either disapprove or delay the approval of a drug that is both safe and effective. In that case, the victims will be invisible. They will have no idea that their suffering could have been eliminated, or in the case of death, their loved ones will have no idea why they died. Their suffering and/or death will be chalked up to the state of medicine rather than the status of an FDA drug application. Their doctor will simply tell them there’s nothing more that can be done to help them. The FDA officials go scot-free.

Today, the Phoenix-based Goldwater Institute is leading the battle to bring some sanity and compassion to the drug approval process…

One Goldwater Institute suggestion is to allow drugs approved in certain other countries, such as Canada and the European Union, to receive nearly automatic U.S. approval. After all, those countries have drug regulatory structures similar to that in the U.S. Why should treatments approved in those countries not be available here?

The Goldwater Institute is also calling for a bill to restore free speech in medicine. It thinks Congress should allow drug manufacturers to provide information about “off-label use.” This is a common practice in which doctors prescribe FDA-approved drugs to treat conditions other than those the FDA originally approved them for after new beneficial uses arise.

Strong evidence of FDA over-caution bias comes in the 1974 words of then-FDA Commissioner Alexander M. Schmidt: “In all of FDA’s history, I am unable to find a single instance where a congressional committee investigated the failure of FDA to approve a new drug.”

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