Efficacy testing -- those phases 2 and 3 -- are entirely unnecessary. They didn't exist prior to 1962's Thalidomide backlash, ironically despite the fact that Thalidomide failed safety testing in the US and was not approved for use.
So it's simple: After phase 1 safety testing, allow drugs to be marketed, but mandate postmarketing surveillance for a period of 5 years to try and tease out real-world safety, efficacy, and drug interactions. This would ultimately result in a better and safer system, as quite a lot of drugs have problems that aren't revealed in phases 2/3 anyway. (e.g. rosiglitazone.)
This simple fix would not only speed up drug development, it would also make drug development a lot cheaper. Compared to the current paradigm, it would heavily incentivize R&D, and bright young minds might see the development of therapeutics as something potentially rewarding. Whereas, today, nobody in their right mind wants to get into pharmaceutical development when they could be making much more money, with much less red tape, in tech.
how would someone under such a system decide to take a drug or not? what information would they have?
Physicians' associations, such as the American Heart Association, can issue treatment guidelines based on available clinical evidence, real-world data, and expert consensus. They already do this anyway, and in most cases their guidelines are the default prescription.
Also: Postmarketing surveillance data, peer-reviewed journals, mechanistic analysis, etc. There are lots of ways to decide which drugs might be of benefit. Leaving the decision to the FDA has, to this point, done far more harm than good.
Insurance companies would decide.
Raise your hand if you think that would be better.
The largest single payer in the US is the Federal government. Medicare, Medicaid, Tricare, the VA... The problem won't be fixed for the vast majority of expenditures because the government will need to perform the same function the FDA is now for it's drug costs.
Maybe. But cheaper drug development should also make for cheaper drugs, which will weaken the stranglehold the insurance companies have on drug supply and distribution.
That's what USA has now. It sucks.