Recently, a number of college students at Princeton and UC Santa Barbara have caught Meningitis B, with some of them dying and others becoming permanently disabled. There is a FDA approved vaccine for other types of Meningitis, but not for type B. The vaccine for Meningitis B has been approved in Europe and Australia, but not in the U.S. I blame the FDA for those young students who have become permanently disabled. I feel this issue particularly because my son attends UCSB and one of his roommates was on the Lacrosse Team with one of the students who was victimized by the illness.
Critics of our regulation of medicines and vaccines have long pointed out that the FDA has a strict standard for approving drugs which means that many drugs that could provide benefits to the population are denied to them. While a strict standard protects against harm from dangerous medicines, it also prevents and delays the introduction of beneficial drugs. Getting the balance right is essential.
FDA critics have long claimed that the FDA standards are too strict in part based on examining the results of the agency’s actions. But they have also argued that the FDA has biased incentives. If they approve a drug that later turns out to be dangerous, the FDA is blamed for it. But if they delay a drug that is beneficial, they usually don’t receive much criticism.
Since the vaccine has been approved elsewhere (and because FDA allowed the vaccine to be imported by Princeton University), I assume it is safe and effective – and therefore blame FDA for the harm caused by the illness. But even if it turns out that the FDA is correct and the vaccine should not be approved, I still paradoxically believe it is appropriate to blame the FDA. It is only if they are blamed for not approving drugs (even if they sometimes are right) that they will no longer face biased incentives to approve safe and effective drugs.