The volume of patients is irrelevant, the FDA could easily open up the market to competition by bringing in suppliers that were approved by other nations with similar medical standards. They could even compare the statistics regarding complications arising from the drug, it&#x27;s not exactly like there would be a shortage of applicable data. Why they choose not to do so is beyond me, perhaps other drug companies would fight back against such a move, even if it was only limited to generics.<p>On a side note, regarding those 2000, there&#x27;s evidence that toxoplasmosis is under treated in the US, particularly with regards to pregnant women.<p><a href="https:&#x2F;&#x2F;med.stanford.edu&#x2F;news&#x2F;all-news&#x2F;2011&#x2F;10&#x2F;u-s-not-taking-basic-step-to-prevent-toxoplasmosis-in-newborns-researcher-contends.html" rel="nofollow">https:&#x2F;&#x2F;med.stanford.edu&#x2F;news&#x2F;all-news&#x2F;2011&#x2F;10&#x2F;u-s-not-takin...</a>