The big news late yesterday afternoon was the resignation of Scott Gottlieb as FDA commissioner. I have no idea why he’s leaving, naturally. He’s spoken about wanting to spend more time with his family and being dissatisfied with going back and forth between Connecticut and DC, and I have no doubt that both of those are true. But one has to wonder if they’re the full story.
Gottlieb has done a good job, and there are too few appointments at his level in the current administration that you can say that about. He’s been active and public-facing (as a look at his Twitter account will demonstrate), and he’s been addressing some big issues in both public health and in drug industry regulation. I’m unhappy to see him leaving, and there’s a tiny bit of evidence at right that others feel the same way. The XBI biotech index staggered the minute the news came out, and it’s down even more today. That’s many billions of dollars of market cap disappearing before your eyes, and it’s due both to the loss of Gottlieb and the fear of what might come after.
I suspected that that fear was one of the things that smoothed Gottlieb’s own confirmation, but the issue is back. Names were floated earlier of people with rather. . .vigorous. . .views on the role of the FDA in drug research, views mostly leaning towards images of a bunch of old tractor tires dumped across a busy road. You’d think naively that the biopharma industry would be all for someone who would reduce the regulatory burden, but that’s really not the case. The thing is, a relatively high bar for approval has a lot of good futures. It forces companies to innovate, to come up with things that are worthy of close scrutiny, and it simultaneously discourages shortcuts and sloppiness. The worry is that if someone tries to do the world a favor by getting the big ol’ slow FDA out of the way, that the result will not be a flood of grateful innovation, but rather a flood of lower-quality drug submissions. At the extreme, you’ll get junk, but even short of that you run a real risk of letting therapies through that are both less effective and more harmful.
The moral hazard – well, one of the moral hazards – is that such moves would be justified by pointing to an apparent surge in drug applications and approvals. See, just get the government out of the way and everything starts to flourish! But as I’ve said many times, the FDA is not the real roadblock in this business. It’s biology. More specifically, it’s our lack of understanding of biology. Lowering standards will do nothing to help that at all.