The FDA Should Stick to Safety

Article published in Wall Street Journal

Today the Wall Street Journal ran an opinion piece written by David R. Henderson and me. The topic is something that he and I have been discussing for years. [Solomon S. Steiner has also played a key role in these discussions.] In short, the FDA doesn’t need to and shouldn’t assess new drugs for efficacy. While that sounds crazy, it’s actually quite sane. Some excerpts:

Here’s a solution: Remove efficacy from the FDA’s approval process and focus on safety alone. That would improve doctors’ ability to match patients with the best drugs and help Americans live longer, healthier lives.

Safety and efficacy are fundamentally different. Lack of safety kills. Lack of efficacy requires trying a different drug.

We’ve done it before. From 1938 to 1962, the FDA assessed drugs for safety only. Why did the FDA rules change in 1962? Congress misunderstood the implications of the thalidomide tragedy and passed the Kefauver–Harris Drug Amendments, which required proof of efficacy. Thalidomide was effective; it wasn’t safe.

Economist Sam Peltzman compared the number of new chemical entities—not only drug reformulations—approved each year by the FDA before and after the law was changed. He found that approvals post-1962 were 61% below what he projected they would have been. We were getting four new beneficial drugs approved when we should have been getting 10. Mr. Peltzman found no increase in safety or efficacy after 1962.

In my next post I will add some material that had to be cut to fit the WSJ’s word limit and address some of the questions and comments we’ve gotten.