I'm not disputing the existence of safety/efficacy standards. I'm disputing the implementation.
A "gentlemen's agreement" is bound to disintegrate - it's just begging for someone to defect. If regulatory mechanisms allow exploits like this they are clearly broken.
Of course it's unlikely the FDA will fix this since their incentives are just as broken. If they prevent millions of people from getting potentially lifesaving drugs they keep their jobs. But if a few photogenic babies die due to a drug that they approved, congressional inquiry incoming!
Since we are talking orphan drugs that are no longer under patent, they do look like a natural monopoly to me, and there are tools in the economic toolbox to handle these. Regulated utilities show how it's done.
There is no need for FDA dissing here. What "photogenic babies" are you even talking about? And who are the "millions of people"? We are talking orphan drugs! Do you have any examples or nothing beyond rhetoric?
The biggest problem facing R & D in the phrmaceutical industry is that incentives for investment that the market provides are completely at odds to what is needed on the ground.
Since you claim these drugs are a natural monopoly, what prevents a competitor from producing them?
I'm discussing the fact that the FDA has incentives misaligned with the public good. If they approve X and something bad happens, they get heat from Congress and the media. If they reject something unnecessarily no one cares.
The biggest problem facing R & D in the phrmaceutical industry is that incentives for investment that the market provides are completely at odds to what is needed on the ground.
It's well-known in the trade that there is an upcoming public health crisis because of antibiotic resistance, yet the biggest research efforts go to cancer drugs because that's what provides the highest return on investment. Hell, I am on cancer money, but what we really need is new antibiotics! Also, no one wants to introduce any new class of drug to the market because the research effort is too expensive and the market does not exist. The market in current statins is so much bigger than it was when Merck introduced the first one, and they had to go and verify the target, the mechanism, everything. Merck did all that for every other competitor that wants to bring another statin to market.
It really is the financing model that is opposed to the public good. People will admit it freely. And the heat that the FDA gets when something slips past them is incomparably smaller than the heat the pharmco gets. Anyone remember Vioxx and the cardiac side effects?
The FDA's incentives are aligned with the public good. There are already drugs for most conditions, and if there is anything that performs outstandingly well in clinical trials there is the fast track.
As for the natural monopoly, it's a fact that the number of manufacturers for any given drug is surprisingly small. For orphan drug the market is so small that it's inevitably just one manufacturer. The upfront costs to qualify equivalence are just a contributor.
A "gentlemen's agreement" is bound to disintegrate - it's just begging for someone to defect. If regulatory mechanisms allow exploits like this they are clearly broken.
Of course it's unlikely the FDA will fix this since their incentives are just as broken. If they prevent millions of people from getting potentially lifesaving drugs they keep their jobs. But if a few photogenic babies die due to a drug that they approved, congressional inquiry incoming!