I appreciate the long response, and I kind of feel bad because I meant my question in a rather different way. And (assuming you even notice my response at this

I appreciate the long response, and I kind of feel bad because I meant my question in a rather different way. And (assuming you even notice my response at this point) perhaps I'm going to take us down a road of talking past each other. My question is about incentives. An unchallenged organization, I would think, would have the tendency to perpetuate itself, and sing its own praises, and deem itself very important. Let me put it this way: The analogous question isn't what Microsoft does to maintain quality. The question is, how does the world at large maintain Microsoft's quality (and efficiency?). A decade or so of security embarrassments and OSX's and Linux's better reputation got them to step up their security game. Recently, Apple's design got them to step up their design game. If you asked a manager for a canceled project inside the company they might have a great process plan, a great argument for why they need more time and resources, and a great explanation for why they and their team are important. But they may have no sense of the needs of the outside world. This exchange between Steve Jobs and an (apparent) Apple employee highlights this mentality, vs the mentality of an entrepreneur who does respond to the outside world: https://www.youtube.com/watch?v=FF-tKLISfPE https://www.youtube.com/watch?v=FF-tKLISfPE It very well may be that the FDA does a fantastic job of filtering out bad stuff. And, as (I may as well come out and say it) a libertarian, perhaps I am guilty of not appreciating all the work that has gone into setting it up. But it doesn't mean that they have a sense of the correct amount of rigor to apply, money to spend on various aspects of their operation, etc. That's why we like to see competition in the field of certification. "That a business should go bankrupt before 1 bad drug is approved." and "some of the largest fines against businesses in history" are great examples of perhaps being a bit too rigorous or punitive. You can always apply more and get at least marginally safer drugs. But you may also get fewer drugs through the process, or more expensive drugs, or companies that decide not to even bother starting the process (which you'll never hear about), and (maybe) more people die on net as a result. I will grant to you, taking your claims at face value, that you make a convincing case that the FDA at least hasn't gotten lax for the lack of outside corrective influence. I guess the mechanism for improvement there is simply human dedication, and I will buy that argument.