FDA Won't Say When Gilead Applied For Orphan Status On COVID-19 Treatment, Calling It 'Secret'

from the oh-come-on dept

Update: Facing tons of public pressure and ridicule, Gilead has agreed to give up the orphan designation.

I'm still pretty ticked off about the FDA's absolute bullshit decision to grant remdesivir "orphan drug" status for COVID-19 status. As I explained in the post yesterday, orphan drug status is supposed to be for rare diseases, in order to create an extra incentive for drug makers to find and deploy drugs to treat those diseases with a smaller than usual market. It would be ridiculous to argue that COVID-19 fits the bill. However, as the law in the US currently stands, the definition of a "rare" disease, is one that effects fewer than 200,000 people. The problem -- and the loophole that Gilead Sciences is exploiting here -- is that there's no concept of time and infection rate. The law was written with an idea that the rate of a disease would be relatively constant, so if you apply for orphan drug status at under 200k possible cases, it would remain that way.

Gilead, instead, is exploiting this loophole by basically rushing to the FDA before we'be even tested COVID-19 enough to know how widespread it is, and before we have enough real data or understanding of how wide it has spread. However, given what's happening around the country and the globe, to argue that this is a small market drug that needs extra protections is obviously ludicrous. Even worse, under the law, having the disease later impact more than 200k people is not a reason that the FDA can remove the status.

When a drug has been designated as an orphan drug because the prevalence of a disease or condition... is under 200,000 in the United States at the time of the designation, its designation will not be revoked on the ground that the prevalence of the disease or condition (or the target population) becomes more than 200,000 persons.

So, basically, rushing to the FDA works wonders. Meanwhile, Claire Cassedy from Knowledge Ecology International, wrote to the FDA to ask for clarification on just why Gilead got the orphan drug status, and was told (of course) that it was because of the "fewer than 200,000 people" criteria. She also asked exactly when Gilead applied for the designation and was told that was a "commercial secret."

What the actual fuck? How is that a commercial secret? We publish when patent, copyright and trademark applications are made. How could this possibly qualify as a secret?

Of course, the much bigger what the fuck is why would the FDA go along with this obvious abuse of process? At the very least, Congress needs to close this loophole so that the next big, fat, and happy drug maker can't abuse it for the next pandemic as well...

Filed Under: covid-19, fda, orphan drugs, remdesivir, secrecy, transparency
Companies: gilead sciences


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  1. icon
    Gorblimey (profile), 25 Mar 2020 @ 9:54am

    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-coronaviru s-drug-yet/


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