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David, The Economic Model's avatar

I can't help but notice that the FAA has done a better job killing general aviation, the DOE has done a better job of killing nuclear power, etc. than the ATF has done of killing civilian firearms ownership. Seems like the rest of society would do well to take a note from the firearms community's playbook and adopting a "not one more inch" adversarial stance to any administrative regulation at all. Sorry if this was too off-topic, just thought it worth pointing out that the industry with the most adversarial relationship with its regulatory agency is also the most healthy.

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Eye Beams are cool's avatar

"If the regulations were of good form there wouldn’t need to be a ‘negotiation’ because there’d be very clear rules and nothing left to negotiate. If there is a negotiation, either the FDA is claiming the right to make arbitrary demands, there is no way to know when you’ve done what the FDA requires without getting them to say so, or Abbott actually can’t satisfy the requirements of a safe plant and the FDA is finding a way to let them operate anyway."

Its not with the FDA, but I have profesional insight into this. Yes, this is *exactly* how every single interaction with a regulator works. They make a list of demands on my client. The client gives the list to us. We pull out the big book of regulations that regulate how the regulator must regulate out client, and then we send a document to the regulator outlining how the regulator is not following the regulation regulations. The regulator then provides this letter to the person who decides if the regulator regulated us according to the big book of regulations. This person is the regulator who made the illegal regulations in the first place. The regulator will comply with our demands just enough to make "bring in the lawyers and sue the agency" a negative EV proposition. We bluff and say "we are bringing in the lawyers" and the regulator says "well, what if instead of this one illegal demand, I illegally require this other illegal demand." Then we figure out how expensive that will be and either take him up on the offer or appeal to the person who decides if his new illegal demand is illegal. This is also the same person. Then we help our client do whatever illegal demands are placed on them. Sometimes we help them do the legal demands from the regulator, but usually the regulators don't care about that. They want to 1) minimize their work and 2) not get red flagged on the automated quality control check after they give us a little slip of paper stating that, while we aren't in full compliance, we aren't going to be shut down today.

Sadly, this isn't nearly enough information for me to dox myself because there are so many industries regulated like this you'll never know which one I am talking about.

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