How the FDA limits access to life-savings drugs

Paul Hsieh, MD writes:

America has a serious drug problem, but it’s not one most Americans have heard of. The problem is not illegal drugs, but rather a critical shortage of many life-saving legal drugs. And the federal government is about to make things worse.

During the past year, medical professionals have received alarming reports about critical shortages of important drugs. These drugs aren’t the common over-the-counter medications that consumers purchase in their local drugstores. Rather, the shortages are in various injectable drugs typically administered to seriously ill patients in hospitals. …

Of course, various factors can contribute to the shortage of any specific drug — for instance, a manufacturing problem at a key factory or difficulty obtaining a particular raw material from an unstable foreign country. But as ABC News notes, often the problem is simply that “the production cost outweighs the profits.” And a leading cause of this problem is the federal government, specifically in the form of the Food and Drug Administration (FDA)

Read the whole article at Pajamas Media: America’s Other Drug Problem.

As an example of private product safety certification, Dr. Hsieh notes that a private organization certifies whether bicycle helmets are effective.

Ways to reform the FDA include: (1) base approval only on safety, not effectiveness, (2) remove its approval powers, and only allow it to give its seal of approval, (3) let people take medications approved by other ratings agencies, (4) abolish it & allow non-government organizations to certify medications.

See also: “The Food and Drug Administration,” Chapter 39 of the Cato Handbook for Congress, 108 Congress.


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