Walter Williams on the FDA

Walter Williams makes some good points in his article FDA: Friend or Foe? In particular, he notes the following tension:

Some drugs are highly beneficial to certain patients but pose an unacceptable risk to others. ... So if you're an FDA official, what are your incentives in terms of whether to approve or disapprove the marketing of a drug that has a tremendous benefit to some patients and poses a health threat to others?

Former FDA Commissioner Alexander Schmidt hinted at the answer when he said, "In all our FDA history, we are unable to find a single instance where a Congressional committee investigated the failure of FDA to approve a new drug. But the times when hearings have been held to criticize our approval of a new drug have been so frequent that we have not been able to count them. The message to FDA staff could not be clearer."

There's little or no cost to the FDA for not approving a drug that might be safe, effective, and clinically superior to other drugs for some patients but pose a risk for others. My question to FDA officials is: Should a drug be disapproved whenever it poses a health risk to some people but a benefit to others? To do so would eliminate most drugs, including aspirin, because all drugs pose a health risk to some people.

He also notes that the FDA lately has been rejecting drugs because they aren't unique enough from what is already on the market. To which he responds:

According to the FDA's literature, its mandate is: "Once a new drug application is filed, an FDA review team — medical doctors, chemists, statisticians, microbiologists, pharmacologists, and other experts — evaluates whether the studies the sponsor submitted show that the drug is safe and effective for its proposed use."

Nothing in the FDA mandate requires that a drug has to be better than what's currently available in order to win approval.

Henderson and Hooper argue that in the worst-case scenario where Arcoxia is no better than existing drugs, it would compete with those drugs. Two centuries of economic theory and evidence show that competition is good. A new drug that competes with existing drugs would moderate drug prices and cause competitors to stay on their toes.