> It might be better if the FDA and its counterparts instead regulated for drug _safety_ in humans and let the academic and clinical communities evolve their pr

> It might be better if the FDA and its counterparts instead regulated for drug _safety_ in humans and let the academic and clinical communities evolve their professional consensuses. The problem is that safety is not binary - it's a question of severity and probability of adverse effects vs the benefit of the drug (the risk of adverse side effects is more acceptable for a cancer treatment than a cough medicine for instance). The purported purpose of regulation is to balance risk vs benefit. Therefore the regulator needs to incorporate the indication into their decision, and so they must evaluate if it actually works.