In a comment on my co-blogger Alberto Mingardi’s post on the FDA, AlanG writes:

FDA has to evaluate new drugs based on their risk/benefit profile. Large clinical trials of new vaccines destined to be administered to healthy children are required to really understand what risks might be present. Would you want this any other way?

Yes, I would. So would my friend and co-author Charley Hooper.

Here’s part of what I wrote in my health care chapter in The Joy of Freedom: An Economist’s Odyssey:

These delays are killing people. In December 1988, for example, the FDA approved Misoprostol, a drug that prevents gastric ulcers caused by aspirin and other nonsteroidal anti-inflammatory drugs. In some other countries, Misoprostol was available as early as 1985. Using the FDA’s own estimates, Sam Kazman, an FDA expert at the Competitive Enterprise Institute, a public-interest lobby in Washington, concluded that Misoprostol would have saved 8,000 to 15,000 lives a year. Thus, the FDA-caused delay cost over 20,000 and as many as 50,000 innocent lives. And that’s just their delay on one out of hundreds of drugs.

The tragedy is that these regulations are not necessary. The FDA may have some expertise when it comes to drug safety and efficacy, but on the only issue that matters–your tradeoffs between various risks–you are the expert, and the FDA’s scientists are rank amateurs. Earlier in this chapter, I mentioned my friend Charles Hooper, who also happened to be one of my star undergraduate students and who is now a partner in the biotech consulting firm Objective Insights. Charley wrote:

The choice a patient makes between therapies (with the help of his agent, the doctor) is based on many variables: efficacy, tolerability, side effects, riskiness, monetary cost, nonmonetary cost (e.g., hassle), speed of action. These drug costs and benefits must be judged within the context of many personal values and tradeoffs: the fear of death, the fear of surgery, the fear of the hospital, potential pain, and the individual’s health profile, financial status, value of time, value of health, and risk tolerance. For the FDA to decide what compounds pass this complex tradeoff is preposterous, given that the FDA can never frame the problem from the individual patient’s perspective. One individual’s best alternative could be another’s worst. We have seen this with AIDS patients: “I don’t care if I develop cancer and this costs me $20,000 a year because without it I’m dead in 6 months.” If, instead of medical therapies, they were telling us what kind of washing machines to buy or where to go on vacation, we would consider it laughable. This is what von Mises [Ludwig von Mises, the noted Austrian economist who showed that information problems would prevent socialism from working] said. Centralized bureaucrats cannot make the proper decisions for individuals because they lack the requisite information.

Note: Commenter Don Boudreaux also addresses this issue.