Today the FDA granted Gilead Orphan Drug status for remdesivir for the treatment of COVID-19, on grounds this is a rare disease. The morning of the designation, the U.S. had confirmed, through testing, more than 35 thousand cases, including 8,477… Continue Reading →
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FDA gives Gilead a seven year regulatory monopoly for remdesivir to treat COVID-19, on grounds it is an “Orphan” treating a rare disease
So what just happened?
There are patents on remdesivir held by Gilead. But under 28 USC 1498(a), the US can overcome the patent monopoly, and buy a generic. It can contract with the generic company to make and import to the US. There is already at least one generic company that we have talked to that is developing a generic version. But to sell a drug in the United States, you need FDA approval.
The FDA is not allowed to register an generic version for use for COVID-19 for 7 years under the action the FDA took today, because the U.S. government did not include an exception to the regulatory monopoly in the Orphan Drug Act. Congress can and should fix this. There should not be an exception proof monopoly for rare diseases.
Also, the FDA should be challenged for even declaring COVID-19 a rare disease, given the expectations of how many people are already infected and how many will be infected in a few days.