Make Drug Approval Easier – Econlib

A few days ago, I listened to Russ Roberts’s EconTalk interview of cardiologist Eric Topol on the health issues involved with aging. For some reason, I’m getting increasingly interested in that issue.

An interesting issue comes up at about 36:00 point. Topol states:

We should be using better nanoparticles and keeping that mRNA from ever having untoward side effects. But, we haven’t. The companies that make these are stuck in the original version. But, we got about a billion people exposed to them.

Later, Russ follows up with this:

When you say companies are stuck with their original versions, is that because of the intellectual property protection that they’re relying on and that it’s expensive therefore for them to start from scratch, and therefore they just don’t have an incentive to innovate? Or is there something else going on?

Russ is onto something: the expense of starting from scratch.

Topol responds:

No, I think part of it is the intellectual property. Part of it is they have now had mass production of hundreds of millions of vaccines and to go to a new process–the point being, is: we’ve known that the nanoparticles can be optimized so they even have better penetration. We have these things called self-amplified vaccines where you give much tinier amounts of mRNA. And that’s approved in Japan. But there’s not even a bit of effort to get that going in the United States. That would help reduce the mRNA side effects.

So, these companies, they did very well during the pandemic and they got things going quickly. That’s great; but they’re not keeping up with the field. And we’re seeing in other parts of the world the innovations that we need.

What Topol doesn’t get into is why there’s progress in Japan that is not being replicated in the United States.

The answer is the Food and Drug Administration. Ever since the 1962 change in law, drug companies that want to introduce a drug into the lucrative U.S. market must show not only safety but also efficacy. The requirement for showing efficacy has added almost a decade to the drug development process.

So the issue is not intellectual property per se. It’s that the process of getting approval is daunting.

That’s why it makes sense, as Dan Klein has argued, for the FDA to automatically approve drugs that have been approved by the FDA’s counterpart in even one of, say, a list of 15 relatively wealthy countries.

You might argue that that’s too risky. But if you don’t like the risk, wait until the FDA approves it. Other people can take their chances. That’s what’s so great about freedom. We need more of it.