Matthew Herper is saying “No, apparently not“. And here are the numbers:
As recently as 2008, companies filing applications to sell never-before-marketed drugs, which are referred to by the FDA as “new molecular entities,” faced rejection 66% of the time. Yet so far this year the FDA has rejected only three uses for new chemical entities, and approved 25, an approval rate of 89%.
Those numbers come from a new analysis commissioned by Forbes from BioMedTracker, a division of publishing giant Informa that helps investors track events in the pharmaceutical industry. And if you dig into them, the drop is even sharper.
If you eliminate new uses for the same drug, the approval rate is more like 96%. I’m willing to stipulate that this change is real – it looks pretty convincing. Now the question is, why did it take place? I think that companies are actually doing a better job of working with the agency to run the sorts of trials that it wants to see, and gather the kinds of data that will lead to approval. I also wonder if we’ve seen an increase in post-approval studies. Neither of these are necessarily bad things, as long as the FDA’s priorities are straight. But that’s the big question – has the agency eased up?
Herper’s article is open to the possibility. If that’s the case, then we should see an echo effect over the next few years as problematic approvals run into trouble. But there’s another possibility, that a number of not-great-but-not-unapprovable things are getting through – incremental advances. You hear that sort of description and you think “me-too drugs”, but that’s not necessarily the case. This can happen in totally new therapeutic areas, too, where some new drug is the first thing to treat patients, but doesn’t do it that well.
There’s a sports analogy here. Years ago, Bill James wrote about the baseball truism that “the good teams win the close ones”. He showed that this wasn’t true – in fact, the really good teams tended to have somewhat worse-than-average records in one-run games. That’s because, for one thing, they didn’t have as many one-run games – they tended to win pretty convincingly, and rarely got blown out. And when they did lose, a higher number than usual of those losses were where the other team just squeaked past them. When you think about it, a good record in one-run games really seems unlikely for a truly powerful team.
And so for drug approvals. A totally new therapeutic area rarely opens up wide enough for a mighty curative blockbuster therapy, at least not at first. Medicinal chemistry gets a toehold on some cliff face that no one else has ever climbed, and with any luck, later explorers will find some better way up. So if a number of marginal drugs are getting though, that might actually be a sign of innovation. More data!