On June 22, the Wall Street Journal published an editorial defending the Food and Drug Administration’s accelerated approval of the controversial new Alzheimer’s drug Aduhelm. The drug has been shown to reduce the amyloid plaque that develops in the brains of Alzheimer’s patients. However, researchers are unsure if the plaque is a cause or an effect of Alzheimer’s disease, and if reducing the plaque will have any clinical benefit. Critics of the FDA decision claim that clinical trials have failed to produce convincing evidence that the drug does any good.

In a recent blogpost I argued that the debate over the new drug misses a larger point: that it was a mistake for Congress to add the efficacy requirement for FDA approval to the agency’s original mission of assuring safety and proper labeling. The efficacy requirement only serves to delay approval and increase the cost of new drugs. Ironically, here we have a situation in which the FDA approves a drug despite the fact that its advisory board thinks it lacks evidence of efficacy. Yet, most other times, physicians and suffering patients wait years for the FDA to decide a drug is efficacious and permit them to use it, after which physicians are free to use the drug “off-label,” based upon their expertise, judgment, and knowledge of the clinical literature. 

Furthermore, I point out that complaints about the new drug’s cost to Medicare should be directed at federal rules requiring Medicare to cover virtually every FDA-approved drug and prohibiting Medicare from negotiating drug prices.

I wrote a Letter To The Editor of the Wall Street Journal that made some of these points and it ran in the newspaper today. You can read it here.

I also invite you to watch a Cato online event on this very topic that I will moderate on July 20 at noon EDT. You can register for the event here.