[nhstanley]

Why would they need samples when the chemical structure is so widely known[1]? It's not like it's a biologic where sequence and other formulation details are critically important. Can you explain?

[1] https://en.wikipedia.org/wiki/Pyrimethamine

Edit: I noticed that paulmd, further down, explained why this is important. I didn't realize the rules were this stupid. The FDA should be able to force companies to make their product available for comparison testing. It's insane that it isn't the case.

[Bluestrike2]

Formulating the generics isn't the hard part (well, beyond the chemistry but that's straightforward enough - once you know something can be done, it's just a matter of time and effort). Once a generics company does that, they have to perform bioequivalence testing. It makes a lot of sense, because generics can have different inactive ingredients (fillers, etc.) that can still affect the patient.

But in order to perform that testing, they need examples of the brand-name drug to test against. If a manufacturer can prevent them from gaining access to those examples, then the generic is never coming to market. They can't get a doctor to just write up a prescription for somebody, so they have to go through established distribution channels. There are a lot of other, equally nasty ways manufacturers can use to try and forestall generic versions of their drugs. It's not easy to do, because the laws are written to incentivize generic competition, but if a company thinks it's profitable enough to try (and certain factors are in their favor, like with Daraprim), they can.

The FTC has a really interesting document available on their ongoing efforts to fight anti-competitive pharmaceutical practices if you're interested:

https://www.ftc.gov/system/files/attachments/us-submissions-...

[dperfect]

So perhaps in these cases we should place the blame on certain shortcomings of the FTC's regulation rather than the companies who take advantage of the loopholes. I don't agree with the practices of this company, but if the loopholes exist, I'm not sure we have much reason to expect companies to behave any way but capitalistically.

[tmd83]

Not american but yeah the law enforcement agencies should be more careful about these loophole or at least try to fix them as quickly as possible once they are found out. Maybe there are some other incentives (sometimes) at the top.

But none of that excuses what these guys (I don't have any reasonable word to describe them). Its like saying there was this loophole that makes this kind of murder (not self defense btw.) not punishable by law so I went ahead and killed 50 people. If people dies from these diseases I don't see how it's not fair to put these guys in some murder trail. I wish we had some reliable tools to detect lies and CEOs and PR guys like these had to pass the test before such claims and actions based off such claims (we are trying to make a better drug) could be taken.