I highly recommend the book Legalize This!: The Case for Decriminalizing Drugs (Practical Ethics Series) by Doug Husak
Monopolization of the healthcare system and drug criminalization are two sides of the same coin. With headlines about opioid abuse epidemics, and looking back at how ridiculous the war on drugs is, and how ridiculous it is to have cannabis as a Class I substance, it's difficult to argue that the medical system is somehow functioning well when it comes to drug regulation.
Take acyclovir, which is an important antiviral medication. Research has shown that it's safe for over the counter use, which review panels have acknowledged, but those panels have still recommended against OTR availability because they're afraid of "setting a precedent" with regard to OTR availability.
Drug regulation really has not increased safety at all; it only increases the power of monopolies, legal or illegal.
That being said, clearly the current system has flaws. Perhaps the FDA could alter their requirements for sale to approximate "does not cause harm", with additional classes for "provides more benefit than harm", etc. The problem is, how do you get drug companies to pay for effectiveness studies if they don't have to? This would actually disincentivize such studies.
I think the real issue with FDA regulations are monopolism related more than approval - not that they haven't made the occasional boneheaded move like being reluctant to approve superior sunscreens.
Allowing reimportarion and government bulk purchase negotiations would cut margins and offer good safeguards against monopoly exploitation since if it is cheaper to ship something circularly you are getting ripped off.