[jschwartzi]

Every time one of these articles comes out, people say that the FDA should have been more involved. Every time we hear about some new drug that Europe, India, or China has that is still being cleared in the US, people say that the FDA needs to step back and let pharma companies innovate.

Which is it? I honestly don't think the FDA is culpable in this. They're there to ensure that the manufacturer is meeting a minimum standard of proof, and if the manufacturer is falsifying that proof and ignoring clinical feedback then the manufacturer is solely responsible and needs to be held accountable. But to say that the FDA isn't doing its job here isn't particularly accurate, because they're doing their best to apply the law and ensure that the claims being made are accurate.

[marcosdumay]

The article paints the FDA as very involved with this. To the point it claims the person that approved the drug moved to work in the company shortly after.

Besides, "stepping back and letting pharma companies innovate" is not the same as not participating. The FDA can make drug development cheap by many means, and the required fiscalization or catching that kind of behavior is not done by increasing the weight of the approval process.

[maxerickson]

I don't really have a strong opinion about either issue, but it isn't necessarily incoherent to simply want the FDA be be better in both cases.

Like what if some of the requirements for new drugs are arbitrary (slowing approval) and the standard of proof for novel release mechanisms is too low?

[mtdewcmu]

If the manufacturer claims that it works for 12 hours and it clearly doesn't, then then that's false marketing. The FDA could stop them from making that false claim without taking the product off the market.