4 ms·

Another way to restrict competition is to stop competitors getting samples of your drug. Without samples of the original, it's impossible to prove a generic is

Another way to restrict competition is to stop competitors getting samples of your drug. Without samples of the original, it's impossible to prove a generic is equivalent. Here's an example where patient safety rules were used to stop competitors getting samples: http://marginalrevolution.com/marginalrevolution/2014/09/co-opting-regulation-for-profit.html http://marginalrevolution.com/marginalrevolution/2014/09/co-...

bhickey 11y ago
> Without samples of the original, it's impossible to prove a generic is equivalent. I know we're in FDA-land where logic doesn't rule, but this beggars belief. This is similar to the nonsense by which HFA inhalers knocking generic CFC inhalers off the market. Any competent organic chemist can tell you if you've got pyrimethamine or not. This isn't some exotic chemical. There's published spectra (http://webbook.nist.gov/cgi/cbook.cgi?ID=C58140&Mask=80 http://webbook.nist.gov/cgi/cbook.cgi?ID=C58140&Mask=80). Having a competitor's drug will simply tell you anything new. If it does, they've behaving deceptively.
- refurb 11y ago
  It's not just having the right drug, it's having the right pharmacokinetics. You need original samples so you can see how the drug dissolves, enters the bloodstream and is metabolized. The FDA has a requirement that generics are bioequivalent, not just the same drug.
- kgwgk 11y ago
  "One way scientists demonstrate bioequivalence is to measure the time it takes the generic drug to reach the bloodstream and its concentration in the bloodstream in 24 to 36 healthy, normal volunteers. This gives them the rate and extent of absorption-or bioavailability-of the generic drug, which they then compare to that of the pioneer drug. The generic version must deliver the same amount of active ingredients into a patient's bloodstream in the same amount of time as the pioneer drug." http://www.fda.gov/Drugs/EmergencyPreparedness/BioterrorismandDrugPreparedness/ucm134444.htm http://www.fda.gov/Drugs/EmergencyPreparedness/Bioterrorisma...
- rayiner 11y ago
  I don't see what's illogical about it. Generics get approval without extensive testing under the idea that they're equivalent to an already tested drug. How do you do that without ensuring its actually equivalent in all respects?
  - bhickey 11y ago
    If the FDA has approved certain pharmacodynamics, these should be characterized. With well characterized bioavailability curves, re-running the original experiment doesn't tell you anything. If the FDA is instead approving other characteristics by happenstance, it leaves open the door to market abuses like the one we're seeing.

bhickey 11y ago

> Without samples of the original, it's impossible to prove a generic is equivalent. I know we're in FDA-land where logic doesn't rule, but this beggars belief. This is similar to the nonsense by which HFA inhalers knocking generic CFC inhalers off the market. Any competent organic chemist can tell you if you've got pyrimethamine or not. This isn't some exotic chemical. There's published spectra (http://webbook.nist.gov/cgi/cbook.cgi?ID=C58140&Mask=80 http://webbook.nist.gov/cgi/cbook.cgi?ID=C58140&Mask=80). Having a competitor's drug will simply tell you anything new. If it does, they've behaving deceptively.

refurb 11y ago
It's not just having the right drug, it's having the right pharmacokinetics. You need original samples so you can see how the drug dissolves, enters the bloodstream and is metabolized. The FDA has a requirement that generics are bioequivalent, not just the same drug.
kgwgk 11y ago
"One way scientists demonstrate bioequivalence is to measure the time it takes the generic drug to reach the bloodstream and its concentration in the bloodstream in 24 to 36 healthy, normal volunteers. This gives them the rate and extent of absorption-or bioavailability-of the generic drug, which they then compare to that of the pioneer drug. The generic version must deliver the same amount of active ingredients into a patient's bloodstream in the same amount of time as the pioneer drug." http://www.fda.gov/Drugs/EmergencyPreparedness/BioterrorismandDrugPreparedness/ucm134444.htm http://www.fda.gov/Drugs/EmergencyPreparedness/Bioterrorisma...
rayiner 11y ago
I don't see what's illogical about it. Generics get approval without extensive testing under the idea that they're equivalent to an already tested drug. How do you do that without ensuring its actually equivalent in all respects?
- bhickey 11y ago
  If the FDA has approved certain pharmacodynamics, these should be characterized. With well characterized bioavailability curves, re-running the original experiment doesn't tell you anything. If the FDA is instead approving other characteristics by happenstance, it leaves open the door to market abuses like the one we're seeing.