We should be skeptical of them. Though, very few of us have the knowledge, expertise, or resources to do so effectively. Better to pool our resources and create an organization to handle that for us.

It's not a perfect system, but the general trend over time has been for it to get better. One of the great ironies here is that, the better the FDA gets at finding problems, the more people criticize it for not finding problems. It's so difficult to consistently remember the full implications of the principle that absence of evidence is not, in and of itself, evidence of absence.

This case is particularly interesting because it happened immediately before the Food and Drug Administration Amendments Act of 2007, which included a considerable strengthening of the US's preregistration requirements. This clamped down on a way that pharmaceutical companies game the system that the general public, and even the majority of doctors, is ill-equipped to even understand, let alone push back against.

Granted, that act didn't, I don't think, include anything specifically about off-label usage. So it's somewhat tangential to the issue in question. I'm more trying to point out the shape of the situation. It's sort of a game of 4D chess, and, if one side were to be playing it in a purely "Twitch plays Pokémon" fashion, it would be at a severe disadvantage.