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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  • icon
    Anonymous Anonymous Coward (profile), 25 Mar 2020 @ 7:51am

    Even though we work for you, we also work for them, and us

    The real secret is the deal made with FDA officials for either current or future compensation to allow the 'orphan drug' status to apply. Allowing anyone to know 'when' that status was applied for would lead to additional, uncomfortable, questions about 'why, who, how' and with 'what' justifications in light of all the rest of the evidence. 'Where' isn't important in this context.

    reply to this | link to this | view in chronology ]

  • identicon
    Anonymous Coward, 25 Mar 2020 @ 9:52am

    So, now we know the real reason 'testing' wasn't available...

    It makes sense now, they had to give Gilead time to file for Orphan status before the 'recorded' cases exceeded the 200k limit...

    Nice to see our politicians sacrafice the public and global health rather than allow a billion dollar company to only make 100,000X their investment (since they invested NOTHING), rather than a billion times their investment (of almost nothing).

    Drug development needs to change, any drug development and testing funded by taxpayer or government funding needs to be changed to an open license where any company can produce the 'publicly funded' drugs that have been developed with government funding at a set markup (profit margin) that is reasonable for the work of PRODUCING the drug, not fake R&D that's actually 90% marketing. If you add the Marketing and Advertising expense in a drug company, it will be more than 2x the R&D funding (at most companies, 1000X more at theranose)... which says all we need to know about Research and Development.

    reply to this | link to this | view in chronology ]

    • icon
      PaulT (profile), 25 Mar 2020 @ 10:42am

      Re: So, now we know the real reason 'testing' wasn't available.

      "Nice to see our politicians sacrafice the public"

      As I often, with great sadness, state - if this is a surprise to you, then you really should have been paying attention a long time ago. You're living in a time where your president has recently stated that he's willing to sacrifice lives to get the stock market back on track (because he's tied his re-election to it).

      reply to this | link to this | view in chronology ]

  • 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/

    reply to this | link to this | view in chronology ]

  • icon
    Mike Masnick (profile), 25 Mar 2020 @ 10:36am

    Surprise! Gilead agrees to give up orphan drugs designation

    Story coming soon...

    reply to this | link to this | view in chronology ]

  • identicon
    Anonymous Coward, 25 Mar 2020 @ 10:58am

    I told everyone at techdirt this breakout of coronaV was going to be a FUCKALL for big pharma. CoVid19 is the perfect big pharma trillion dollar generator weapon.

    reply to this | link to this | view in chronology ]

    • identicon
      ROGueS, 28 Mar 2020 @ 9:36am

      Re: Stop the CONSPIRACY THEORIES already!

      Techdirt.com is NOT a place for these sordid, unfounded conspiracy theories!!!!

      Stop spreading RUMORS and #fakenews!!!

      ( but isn;t it funny how the Maatje Benassi has been fingered in this debacle now?) Lulz.

      CoVid19 is the perfect big pharma trillion dollar generator weapon.

      There. I fixed that for ya.

      Its not just the "CIA" anymore that feuls these "theories", because they have outsourced all their dirty tricks to corporations, Non Governmental Organizations, and universities and Big Tech.

      COVID-19, properly investigated, will make the Tuskeegee/Guatemala syphillis experiments look like a child's playground. Lord of the Flies comes to mind.

      (and have you seen what they are actually doing with children around the world, via their scurrillous NGOs that claim to "save the children"? Fuckall...we are truly doomed. Those poor kids....and the deists.agnostics, seculars. atheists are all too rational, "scientific" and "sceptical" to stop it.)

      reply to this | link to this | view in chronology ]

  • identicon
    Bob, 25 Mar 2020 @ 11:13am

    Flights

    Based on the flights of their aircraft, they were in DC greasing the wheels on March 8-10th - Falcon 2000S N410GS Also take a look at their other aircraft, N278GS, N585GS and N977GS

    reply to this | link to this | view in chronology ]

    • identicon
      ROGueS, 28 Mar 2020 @ 12:02pm

      Re: Flights

      Flightaware.com is a GREAT website,to monitor the monitors.

      We monitored the Ferguson and Baltimore protests at that amazing site,with replicable results.

      And, I personally had shitbag DHS/FBIIsraeli/FVEYs/local police/ Law Enforcement Intelligence units (LEIUs) breaking in to my house at that time(of course I photographed those faggots on hidden camera, and publicized it widely).

      At Ferguson, my internet connections were routed through the Tennessee Fusion Center (with evidence), and elsewhere.

      So, yeah, Flightaware.com is an indispensible journalistic resource, Thanks for the plug, Bob.

      reply to this | link to this | view in chronology ]

  • icon
    Tim R (profile), 25 Mar 2020 @ 11:47am

    What the actual fuck? How is that a commercial secret?

    I'm wondering if a clue to that question comes in the previous article Mike wrote on this subject:

    It gives the company extra exclusivity regardless of the validity of Gilead's patents. The FDA will not allow others to use the same chemical for seven years -- again, no matter the status of Gilead's patents. On top of that, Gilead can potentially get a 25% tax credit.

    One can't help but wonder when the clock actually started running on this, and how they might be able to strong-arm other companies that don't exactly know when that seven years is really up.

    reply to this | link to this | view in chronology ]


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