8 ms·

> With the price now high, other companies could conceivably make generic copies, since patents have long expired. One factor that could discourage that option

> With the price now high, other companies could conceivably make generic copies, since patents have long expired. One factor that could discourage that option is that Daraprim’s distribution is now tightly controlled, making it harder for generic companies to get the samples they need for the required testing. > The switch from drugstores to controlled distribution was made in June by Impax, not by Turing. This is the culprit, and honestly I have no idea what "controlled distribution" means in this context. Anybody would like to clarify?

paulmd 11y ago
In order to produce a generic, you need to prove that it has the same efficacy as the namebrand drug. It's not the same thing as a full FDA trial, it's small-scale and you're basically just proving that you're ending up with the same active ingredient and that it has the same effects in patients (i.e. you're not doing something differently in the formulation/delivery that's causing problems or impeding the efficacy of the drug). You can't do that for these drugs, because the only way to get ahold of the namebrand drug is from the official supplier, and they won't sell it to you.
- danmaz74 11y ago
  Thanks for the explanation. But this rule - ie, not allowing the competitor to buy the original product for testing - is incredibly anti-competitive and should be banned.
  - aianus 11y ago
    Or, you know, you could remove the stupid regulations around generics. I trust Bayer is capable of copying some crappy 60-year-old drug without the FDA taking 6 months to approve it.
    - cowsandmilk 11y ago
      Because Bayer has never had manufacturing issues[1]? And who decides what companies are trustworthy enough to manufacture drugs? Yes, Bayer is capable, but like many companies, they also have people in their facilities that try to cut corners to make themselves look good. Passing the FDA review is fairly straightforward. [1] http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm182206.htm http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/u...
      - aianus 11y ago
        > And who decides what companies are trustworthy enough to manufacture drugs? You could consider them innocent until proven guilty if they have enough capitalization and/or insurance to settle any lawsuits if they screw up.

paulmd 11y ago

In order to produce a generic, you need to prove that it has the same efficacy as the namebrand drug. It's not the same thing as a full FDA trial, it's small-scale and you're basically just proving that you're ending up with the same active ingredient and that it has the same effects in patients (i.e. you're not doing something differently in the formulation/delivery that's causing problems or impeding the efficacy of the drug). You can't do that for these drugs, because the only way to get ahold of the namebrand drug is from the official supplier, and they won't sell it to you.

danmaz74 11y ago
Thanks for the explanation. But this rule - ie, not allowing the competitor to buy the original product for testing - is incredibly anti-competitive and should be banned.
- aianus 11y ago
  Or, you know, you could remove the stupid regulations around generics. I trust Bayer is capable of copying some crappy 60-year-old drug without the FDA taking 6 months to approve it.
  - cowsandmilk 11y ago
    Because Bayer has never had manufacturing issues[1]? And who decides what companies are trustworthy enough to manufacture drugs? Yes, Bayer is capable, but like many companies, they also have people in their facilities that try to cut corners to make themselves look good. Passing the FDA review is fairly straightforward. [1] http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm182206.htm http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/u...
    - aianus 11y ago
      > And who decides what companies are trustworthy enough to manufacture drugs? You could consider them innocent until proven guilty if they have enough capitalization and/or insurance to settle any lawsuits if they screw up.