Gilead Sciences asked the FDA to take back orphan drug status for its experimental drug, remdesivir, which is being tested to treat COVID-19, after the drugmaker was criticized for pursuing a monopoly for the drug that could help combat the novel coronavirus pandemic, STAT reported.
Earlier this week, the FDA granted orphan drug status to remdesivir, which gave Gilead exclusive marketing rights to the drug for seven years.
The designation is supposed to be for drugs to treat rare diseases affecting 200,000 or fewer people. However, the law allows drugs treating more common illnesses to be designated as orphan drugs if the designation is granted before the 200,000-person threshold is met.
When remdesivir was given orphan drug status, there were 42,164 cases of COVID-19 in the U.S., according to STAT. But that number was already expected to grow "exponentially" in coming weeks.
The orphan drug status would have let Gilead block lower-cost generic versions of remdesivir for seven years, assuming the FDA decides to approve the drug to treat COVID-19, STAT reported.
Consumer advocate groups, such as Public Citizen, criticized the FDA for granting status to the drug that could combat the current coronavirus pandemic.
"If remdesivir proves to be a viable treatment for COVID-19, then the world cannot afford to have one manufacturer maintain a monopoly over it, particularly given the huge amount of public investment that has gone into the drug," Public Citizen wrote in a statement.
Gilead released a statement March 25 asking the FDA to rescind its orphan drug status for remdesivir and said it's waiving all the benefits it would have gotten from the designation. The drugmaker said it "recognizes the urgent public health needs posed by the COVID-19 pandemic."
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