The FDA Demonstrates Its Incompetence Again

In order to sell pharmaceuticals in the United States they must first be approved by the Food and Drug Administration (FDA). Why does the state get a monopoly on determining whether or not a drug is safe? Because many people have been suckered into the belief that the state is some kind of egalitarian entity that is beyond corruption or mistake, unlike private approval agencies such as Underwriters Laboratories (UL). However, the FDA has a long history of failures. Its most recent failure demonstrates the danger of granting any organization a monopoly on assessing the safety and effectiveness of pharmaceuticals:

The FDA announced last week that the 300mg generic version of Wellbutrin XL manufactured by Impax Laboratories and marketed by Teva Pharmaceuticals was being recalled because it did not work. And this wasn’t just a problem with one batch – this is a problem that has been going on with this particular drug for four or five years, and the FDA did everything it could to ignore it.

The FDA apparently approved this drug – and others like it – without testing it. The FDA just assumed if one dosage strength the drug companies submitted for approval works, then the other higher dosages work fine also. With this generic, American consumers became the FDA’s guinea pigs to see if the FDA’s assumption was right. It wasn’t.

Why would an organization tasked with assessing whether or not drugs are safe and effective fail to test higher dosages of previously approved drugs? Because the organization has a legal monopoly on therefore knows no consequence will befall it for failing in its assigned task.

For a non-state approval organization reputation is everything. UL, for example, has an invested interest in testing every product before granting approval because failing to do so could harm its reputation. An approval organization that has a poor reputation isn’t going to be relied on by anybody. The FDA, and other government created monopolies, face no risks because their approval can be mandated by law.