The secrecy sucks, but "Orphan Drug" status is not always for "rare" diseases; this Ars Technica article discusses the details.
"However, the Orphan Drug Act does have an exception for more common diseases with unmet needs. So the FDA is allowed to consider granting orphan drug status to a treatment for "[a] disease affecting over 200,000 persons in the US, but for which there is no reasonable expectation that the cost of developing and making available a drug for such disease will be recovered from sales in the US." It's this provision that Gilead used with its remdesivir orphan drug application."
Also, the status has not been APPROVED; that can take years, Gilead already has a patent on it, and the FDA could give permission for other companies to make/market it.
The Stitcher podcast app is no longer updating with TechDirt. https://www.stitcher.com/podcast/techdirt-podcast I will also contact them about this....
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The secrecy sucks, but "Orphan Drug" status is not always for "rare" diseases; this Ars Technica article discusses the details.
"However, the Orphan Drug Act does have an exception for more common diseases with unmet needs. So the FDA is allowed to consider granting orphan drug status to a treatment for "[a] disease affecting over 200,000 persons in the US, but for which there is no reasonable expectation that the cost of developing and making available a drug for such disease will be recovered from sales in the US." It's this provision that Gilead used with its remdesivir orphan drug application."
Also, the status has not been APPROVED; that can take years, Gilead already has a patent on it, and the FDA could give permission for other companies to make/market it.
https://arstechnica.com/science/2020/03/no-a-biotech-hasnt-used-loophole-to-lock-down-coronavirus-drug-yet/
Techdirt podcast not updating on Stitcher?
The Stitcher podcast app is no longer updating with TechDirt.
https://www.stitcher.com/podcast/techdirt-podcast
I will also contact them about this....