At first I was puzzled by the upvotes because pro-monopoly arguments are usually unpopular here, but then I realized that I didn't really express myself clearly and that probably my argument was misunderstood :) So I'm not against drug monopolies, or patents, (or copyright, for that matter) - in fact I'm staunchly pro those things; the problem in this case is the strictness of the FDA, setting an arbitrarily high bar, causing all but one manufacturers to not be able to produce the drug any more.
The point of the article was that the FDA used to approve other manufacturers, but then required higher standards which only one manufacturer can meet. So now there's a de facto monopoly - not because of a patent, but because of the requirements the FDA set (retro-actively). The FDA needs to restrict itself to more basic testing (rather, testing requirements) so that the market can take over in the price setting of the drug through competition.
(I'm not an expert on the chemistry and medical aspects of pharma; actually I don't know anything about it. I don't know if, in the specific case of the article, the additional requirements set by the FDA are really required, or just paranoia. I think the FDA, and similar bodies in general, need to relax on their 'err on the side of caution' principle. To put it extremely - yes it sucks to be harmed by a thus far unknown side effect of a drug or food, but requiring near-100% safety on everything on the market hampers progress, and we can't know if the positive effect outweigh the negative ones. I hypothesize they don't, but until we know, let's lay off the state nannying, and replace it with a clearer mechanism to let consumers know how far something has been tested, so that they can make their own choices on whether or not they want to take/eat the drug/food).
You do not seem to understand orphan drugs or this article. Basically every word of your second paragraph is incorrect.
These are drugs that have never been approved by the FDA. No manufacturers were previously approved and no standards have been changed.
The FDA wanted clinical trials on the drugs. There are incentives in place to encourage companies to develop drugs for rare conditions where there are not enough patients to warrant investing in for economic rewards (and yet you envision companies in competition over them). These include grants for the required trials, tax credits for half of the cost of developing the drug, and a seven year monopoly on the drug.
It was my understanding from the article that originally there were several versions of the drug, then something changed (the author seemed to blame the FDA) after which there was only 1 left, and then there was a price hike.
Now it's quite possible that I'm wrong - what was the cheap version that the author was taking before then? Wasn't it a product of a competitor? And if so, why isn't it available any more?
Whatever the prior sources (IIRC, pharmacists could just whip up a batch), making it was cheap, legal, and unrestricted due to grandfathering. FDA wanted to regulate it, and granted someone exclusive rights to achieve it.
It's not available now because the FDA wanted certain tests done which hadn't been. No company did the tests because it wasn't worth their time/money to do so. The FDA _made_ it worth someone's time and money by offering them exclusive rights for 3 years if they did the tests. One company ran the tests, got approved, and was granted exclusivity as a reward. Supply plummeted (manufacturing went from many sources down to one), demand remained high, and prices increased 50x as a natural consequence.
The Law of Supply and Demand rules. It always does. Screw with it and you'll get hurt. The FDA screwed with it, and people got hurt.
It was not legal to make these drugs. However, the FDA did not want to suddenly get rid of drugs people were already taking so focused their efforts on drugs that they thought were harmful first.
Drug testing is designed to prevent actually harm. With the manufacturer's plan it seems that the only people that will have to pay significantly more make over $100k/yr and probably have it covered under their health insurance anyways.
OK thanks, that's indeed a different chains of events than I initially thought, but the derived reasoning still holds - the FDA should've stayed out to begin with.
The point of the article was that the FDA used to approve other manufacturers, but then required higher standards which only one manufacturer can meet. So now there's a de facto monopoly - not because of a patent, but because of the requirements the FDA set (retro-actively). The FDA needs to restrict itself to more basic testing (rather, testing requirements) so that the market can take over in the price setting of the drug through competition.
(I'm not an expert on the chemistry and medical aspects of pharma; actually I don't know anything about it. I don't know if, in the specific case of the article, the additional requirements set by the FDA are really required, or just paranoia. I think the FDA, and similar bodies in general, need to relax on their 'err on the side of caution' principle. To put it extremely - yes it sucks to be harmed by a thus far unknown side effect of a drug or food, but requiring near-100% safety on everything on the market hampers progress, and we can't know if the positive effect outweigh the negative ones. I hypothesize they don't, but until we know, let's lay off the state nannying, and replace it with a clearer mechanism to let consumers know how far something has been tested, so that they can make their own choices on whether or not they want to take/eat the drug/food).