5 ms·

So if I get it right, FDA has enforced a monopoly by not allowing competitors to penetrate the market with the same drug.

roel_v 16y ago
Exactly, and this is the problem, not the drug manufacturers.
- zaidf 16y ago
  The counterpoint to that is if they don't grant the exclusivity, the cos won't be willing to invest money and resources to do the testing because the returns wouldn't be as strong. In these cases though, the counter-argument to that is the price jump is unjustified relative to the $ invested in doing the testing.
  - bad_user 16y ago
    I have never seen a government-granted monopoly that did public good, no matter the reasons. If the FDA can't do its job properly, then it should stay the hell out of the way.
    - iwwr 16y ago
      Perversely, these monopolies are often granted on the basis of 'natural monopoly theory'. If it's a natural monopoly, why does it need to be further enforced (preserved?) by a law?
      - roel_v 16y ago
        Eh, what? What monopolies are granted by law on the basis of natural monopoly theory? As you state, there is no reason to put them into law; natural monopolies are usually the ones who are broken up by regulators, to enforce competition (e.g. telecoms, energy manufacturing/distribution, public transport, ...)
        iwwr 16y ago
        These same monopolies you're mentioning (were|are) in fact legally protected from competition.
  - roel_v 16y ago
    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).
    - mukyu 16y ago
      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.
  - Symmetry 16y ago
    In the vaguely similar case of Cylert where there _wasn't_ a monopoly granted the drug just ended up disappearing and the people taking it were SOL. http://nielsenhayden.com/makinglight/archives/007140.html http://nielsenhayden.com/makinglight/archives/007140.html EDIT: Which is to say that the problem is the FDA jerking people around in general.

roel_v 16y ago

Exactly, and this is the problem, not the drug manufacturers.

zaidf 16y ago
The counterpoint to that is if they don't grant the exclusivity, the cos won't be willing to invest money and resources to do the testing because the returns wouldn't be as strong. In these cases though, the counter-argument to that is the price jump is unjustified relative to the $ invested in doing the testing.
- bad_user 16y ago
  I have never seen a government-granted monopoly that did public good, no matter the reasons. If the FDA can't do its job properly, then it should stay the hell out of the way.
  - iwwr 16y ago
    Perversely, these monopolies are often granted on the basis of 'natural monopoly theory'. If it's a natural monopoly, why does it need to be further enforced (preserved?) by a law?
    - roel_v 16y ago
      Eh, what? What monopolies are granted by law on the basis of natural monopoly theory? As you state, there is no reason to put them into law; natural monopolies are usually the ones who are broken up by regulators, to enforce competition (e.g. telecoms, energy manufacturing/distribution, public transport, ...)
      - iwwr 16y ago
        These same monopolies you're mentioning (were|are) in fact legally protected from competition.
- roel_v 16y ago
  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).
  - mukyu 16y ago
    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.
- Symmetry 16y ago
  In the vaguely similar case of Cylert where there _wasn't_ a monopoly granted the drug just ended up disappearing and the people taking it were SOL. http://nielsenhayden.com/makinglight/archives/007140.html http://nielsenhayden.com/makinglight/archives/007140.html EDIT: Which is to say that the problem is the FDA jerking people around in general.