Orphan drug laws exist to ensure that drug development, manufacturing, and distribution happens for diseases that only affect a few thousand people. When the potential market for a drug is relatively small, having multiple companies competing for that market can often decrease the incentives to manufacture and distribute therapies down to the point where no company is willing to take the risk.
Under the FDA rules, the "case limit" for a therapy to qualify for the "orphan drug" rules is 200,000. If there are less than 200,000 cases of a given disease, the FDA will grant special privileges for exclusive marketing (essentially, a monopoly) for any company that is willing to take the risk for drug/therapy manufacturing for such a small market.
You are not going to fecking believe what I'm about to say.
Gilead recently applied for -- and was granted -- "orphan drug" status for remdesivir, a drug that is likely to be used in the treatment of COVID-19. Because confirmed US cases of COVID-19 are still below 200,000 (but will not be for long), Gilead was able to quickly slide in the orphan-drug application.
Since the massive public outcry, they have since rescinded that application.
That took some chutzpah to try to claim "orphan drug" status for the skyrocketing COVID-19
"The Intercept" did good work here.
