[jonlucc]

That's true because it's not trivial to launch a new drug/delivery system. Even generics have to prove that their drug matches the kinetics of the patent drug and has other similar properties. There is still an FDA process to approving a new drug, and if I'm not mistaken, the new delivery device also has to have it's own approval through the FDA medical devices division.

All of that is before you even take into account how much it costs to re-tool your production line to make something different. Sure, you could lower the barriers to entry until they're barely existent and offer almost no consumer protection, but I'm not really sure we want to make it so easy that a company will spin up a production line to make a drug for 6 months while they think they can undercut the competition.

Then again, I'm a big pharma biologist, so I probably am a bit biased toward safety and large, slow movements.

[mattnewton]

A solution to this particular problem could be to make the patents on the existing, known to be safe methods expire earlier, so that in order to retain a monopoly on something big pharma must make a significant patentable improvement.

Critics of this policy say that it would disincentive new drug development. That may be true, but for many people it doesn’t matter because they can’t afford them at current monopoly rates anyways, and our insurance industry is broken for them.

I wonder how you would go about researching a better patent-expiration scheme and the effects it would have.

Edit: maybe I misunderstood you- are you saying even with no patent protection, the barrier to entry is still high enough to disincentivize new entrants because of safety regulation and retooling costs? So patents aren’t the only roadblock, or not even necessarily the main roadblock?

[jonlucc]

I mean what you say in your edit. Even off-patent drugs require basic proof that they are what they claim to be, are similar to the patent drug in important ways, have a safe formulation, require a company to make a production line for it, and even require some marketing in many cases to make sure people know there's a new manufacturer of that drug.

I've never worked in generics, so I'm certainly not an expert, but I am saying both that we need some of the safety and quality controls by the FDA (or some system to replace them without relying on companies' good will) and that there are big hurdles even disregarding the FDA or other regulatory bodies.