Public Pressure Works: Gilead Asks FDA To Rescind Orphan Drugs Designation For Possible COVID-19 Treatment

from the good-to-see dept

Earlier this week, we wrote about the sham orphan drug designation that the FDA gave to Gilead Sciences for remdesivir. As we explained, remdesivir was developed with mostly public funds, and Gilead Sciences already held three patents on it, with a fourth one pending. Orphan drugs designations are supposed to be extra incentives for drug makers to target rare diseases. The issue here was that part of the definition of a rare disease under the Orphan Drugs Act is that it has to affect fewer than 200,000 people in the United States. Ridiculously, the law does not take into account the rate at which the disease spreads -- just how many people have it at the time a drug maker requests the designation. Even worse, the law explicitly says that the FDA cannot remove the designation if the affected group later grows to over 200,000.

Over the last few days, anger continued to grow at Gilead and the FDA -- including with the news that the FDA won't even say when Gilead applied for Orphan Drug status, because that's apparently "a commercial secret." Either way, this morning a ton of public interest groups, organized by Public Citizen, sent a letter to Gilead asking it to renounce its claim for orphan drug status:

We were shocked to learn that your company sought a lucrative orphan drug designation from the Food & Drug Administration for remdesivir, one of relatively few medicines being explored as a possible treatment for COVID-19 this year.

This is an unconscionable abuse of a program designed to incentivize research and development for treatments for rare diseases. COVID-19 is anything but a rare disease. Some estimates suggest that half or more of all Americans may ultimately contract the disease.

We are writing to demand you reverse course and renounce your claim to orphan drug designation privileges for remdesivir.

As you know, Gilead was able receive an orphan drug designation only by rushing to file its application while there were fewer than 200,000 COVID-19 U.S. cases.

The United States most likely will surpass 200,000 COVID-19 reported cases in a matter of days. The real number of people suffering with the new coronavirus likely already has passed this mark. Calling COVID-19 a rare disease mocks people’s suffering and exploits a loophole in the law to profiteer off a deadly pandemic.

And here's the crazy thing. It worked!

Almost immediately after that letter was sent, Gilead announced that it has asked the FDA to rescind the designation:

Gilead has submitted a request to the U.S. Food and Drug Administration to rescind the orphan drug designation it was granted for the investigational antiviral remdesivir for the treatment of COVID-19 and is waiving all benefits that accompany the designation. Gilead is confident that it can maintain an expedited timeline in seeking regulatory review of remdesivir, without the orphan drug designation. Recent engagement with regulatory agencies has demonstrated that submissions and review relating to remdesivir for the treatment of COVID-19 are being expedited.

In early March, Gilead sought and was subsequently granted an orphan drug designation for the remdesivir as a potential treatment for COVID-19. Orphan drug designation is granted by the FDA in situations where the disease affects fewer than 200,000 patients in the United States.

The notice tries to give some justification for the orphan designation, suggesting that it would have made approval easier:

Among the benefits of orphan drug designation, this status results in a waiver of the requirement to provide a pediatric study plan prior to the submission of a New Drug Application – a process that can to take up to 210 days to review.

Gilead recognizes the urgent public health needs posed by the COVID-19 pandemic. The company is working to advance the development of remdesivir as quickly as possible, and will provide updates as they become available

So, in the end, public pressure worked, and the right thing was done.

As a side note, I've seen some people point to this article to suggest that because the FDA had only designated remdesivir as an orphan drug for COVID-19, and not yet approved it, that this story was blown out of proportion. This is wrong. The designation almost certainly eventually leads to the approval, and the mere designation creates a massive chilling effect on others working in the space, as it effectively tells them not to go down that path at all. The designation was a big deal, and a terrible scam pulled off by the FDA and Gilead, and it's good to see that Gilead was realizing that it was being seen as a pandemic profiteer and has backed off.

Filed Under: covid-19, exclusivity, fda, greed, orphan drugs, pandemic, patents, public pressure, remdesivir
Companies: gilead sciences


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  1. icon
    Samuel Abram (profile), 25 Mar 2020 @ 12:01pm

    Public Pressure works.

    Whoda thunk it?

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

  2. identicon
    Michael, 25 Mar 2020 @ 1:09pm

    style guide

    Just as you're allowed to spell "Macy*s" as "Macy's" and "Yahoo!" as "Yahoo," so can you spell "remdesivir" with a capital R to help with readability.

    Remdesivir.

    See?

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

  3. This comment has been flagged by the community. Click here to show it
    identicon
    Andrea Iravani, 25 Mar 2020 @ 1:21pm

    This is a financial problem that we must not allow to turn into a health problem! 

    $640 trillion in derivatives might be a clue that the math is off!
    Anoth clue that the math might be off is that Market Capitalization to GDP ratio went from the ridiculously high 110% at the end of 2016 to the insanity on hallicinogenics of 155% at the end of 2019, growing by 29% while GDP grew 2.25% during the same time frame. Another clue that the math might be off is that less than a dozen publicly traded companies now use GAAP. Another clue that the math might be off is the fractional reserve system itself! 

    Another clue that the math might be off is that the QE under Obama which led to zero interest rates caused a pension crisis, particularly for the federal, state, and local government employees whose pension plans suffered as a result of not earning interest and attempted to make up for the shortfalls through investing in risky stocks, explaining the sky high valuations. It had nothing to do with reality, and everything to do with refusing to admit that the entire economy is based on outright fraud! Until that is addressed, and the guilty parties are held responsible, the problems will only get worse! That is just the reality, and the reality is based on math!

    In 2002, Rockefeller suggested that the U.S. "prepare" for a pandemic, and so did Bill Gates and other Davos World members with Event 201 and ID2020.

    Israeli intelligence "warned" that there will likely be interference and terrorist acts that will interfere with the 2020 election, the same way that Netenyahu "warned" that the World Trade Towers "might" be attacked by "radical Islamic extremists" a couple of years prior to the controlled demolition of the World Trade Towers and attacks on the defenseless, surveillanceless Pentagon, and the dancing Israelis.

    For the first time in income tax history, the government has delayed income taxes to protect their co-conspirators, the high rolling banksters who have once again gambled away customers assets since the repeal of Glass Steagall and the Graham Leach Bliley Act made it possible, in addition to the repeal of blue sky laws for tech start-ups in 1993 that was responsible for creating the Orwellian surveillance nightmare  on Main Street world that we now are forced to live in.

    I have never been to China, but as far as unclean eating habits are concerned, the U.S. homeless population dumpster dives and state and local governments have prohibited and shut down churches, charities, and businesses for feeding the homeless. So, yes, that definitely should be addressed for the sake of public health! BTW, imprisoning the homeless for dumpster diving is not the solution!

    San Antonio Texas has the world's largest bat cave population with 15 million Mexican free tailed bats, hosting tours and hikes at the Backen Bat Cave purchased by Bat Conservation International.

    Logic would place this as ground zero for the corona viruses that have been occuring in this country and throughout the world, then transported to Fort Detrick Bio-weapons lab to be used for population control in an act of domestic and international terrorism to prevent the spread of the truth about the fourth financial fraud induced economic collapse in 33 years.

    http://www.batcon.org/

    The Mexican free tailed bat is also referred to as the Brazillian free tailed bat. It was discovered in 2017 that the  species has had coronavirus A. Also worth noting is that coronavirus has not been detected in European or Asian bats.

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

  4. identicon
    Anonymous Coward, 25 Mar 2020 @ 1:48pm

    Re:

    Cool pasta bro

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

  5. identicon
    Anonymous Coward, 25 Mar 2020 @ 2:52pm

    Re: Public Pressure works.

    Wow, seriously. This is a completely unexpected turn of events. Is big pharma growing a conscience?

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

  6. identicon
    Anonymous Coward, 25 Mar 2020 @ 2:53pm

    Re: style guide

    Genius! You should start your own blog where you can be as big a pedant as you like!

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

  7. icon
    That One Guy (profile), 25 Mar 2020 @ 5:00pm

    Re: Re: Public Pressure works.

    Not a chance, the matter just got enough attention that their survival instinct kicked in and they realized that making themselves a perfect magnet for frustrations and kneejerk reactions from the public and any politician who wanted to make an example out of someone wasn't going to end well for them.

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

  8. identicon
    Andrea Iravani, 25 Mar 2020 @ 10:32pm

    Re:

    It must be just a coincidence that the NCBI website has suddenly been changing links as well as research conclusions on Coronavirus A found from San Antonio now changed to Florida, and previously saying that this was not found in China, now saying that it was. It is just a coincidence, or a deep fake. As well as the coincidence that the link that I posted has vanished again from NCBI, ( Nation Center for Bio Technology. ) 1984! The words change right before your eyes! From bullshit to batshit crazy! We were warned by the DNC and Netenyahu that this would happen! Whoever smelt it dealt it!

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

  9. identicon
    Anonymous Coward, 26 Mar 2020 @ 6:03am

    Re:

    Wait til they bring Henry Kissinger back and declare him to be GOD.

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

  10. identicon
    Anonymous Coward, 26 Mar 2020 @ 6:12am

    Re: Re:

    You think China doesn't know who did this? I think the new world order is counting on them to know. Trying to pick a fight with them with every new news conference from some people its so obvious. They think we are all a bunch of idiots to not be able to see clear through them.

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

  11. identicon
    Anonymous Coward, 26 Mar 2020 @ 6:26am

    Re: Re: Re:

    Its very likely that before China ever throws one missile our way, North Korea's favorite spoiled bad boy will unleash HIS ARSENAL across Europe and US.

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

  12. identicon
    Anonymous Coward, 26 Mar 2020 @ 6:32am

    Re:

    I'm guessing that Bill Gates was taken by surprise at how quickly he got fingered to be involved with this outbreak. He cut ties to ms and tucktailed back to his cave.

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

  13. identicon
    Anonymous Coward, 26 Mar 2020 @ 8:57am

    Re: Re: Re: Re:

    Across a map of the US and Europe laid in the courtyard in Pyongyang maybe. We all know his "missiles" can barely reach Japan but more often than not crash back into the launchpad.

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

  14. identicon
    Anonymous Coward, 26 Mar 2020 @ 8:58am

    Re: Re:

    Fingered by who? A bunch of right wing nutjobs?

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

  15. icon
    Atkray (profile), 26 Mar 2020 @ 12:45pm

    Close the loophole

    It would be nice if congress would just add a line stating that any drug grated orphan status that subsequently climbs above 200,000 cases in the US automatically becomes public domain.

    That would probably fit better with the original intent of getting companies to research drugs for rare diseases instead of the newest disease.

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

  16. identicon
    Pixelation, 26 Mar 2020 @ 1:16pm

    Re: Re: Re: Public Pressure works.

    This shines another light on how the system gets abused by greedy fucking companies. Let's hope enough people see it to create pressure to change the system.

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

  17. identicon
    ROGueS, 28 Mar 2020 @ 10:57am

    Re: Re: Re: Re:

    Thats just stupid, China has never assaulted the west, ever.

    Its more likely that the USA and its FVEYs apparatus is scheming on a way to launch bombs FROM China, and then, BLAME them for the landing.

    Thats the basic premise of ALL western theological war.

    Or, COVID-19 and Maatje Benassi, Bill Gates, et al. (Never Forget that Henry Kissinger and his troup of merry baby killers outlines all of this many years ago)

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

  18. identicon
    ROGueS, 29 Mar 2020 @ 8:36am

    Re: Andrea Iravani, Propaganda Combatant?

    Andrea, note that #brobot just beneath your flagged comment. It is a persistent TD stalker, and it NEVER contrivbutes anything of substance.

    I suspect that a troll farm, or one of TDs inhouse trolls is flagging you.

    As for the comment they tried to hide, I really like this:

    "I have never been to China, but as far as unclean eating habits are concerned, the U.S. homeless population dumpster dives and state and local governments have prohibited and shut down churches, charities, and businesses for feeding the homeless. So, yes, that definitely should be addressed for the sake of public health! BTW, imprisoning the homeless for dumpster diving is not the solution!"

    Excellent humor, and so true.

    And I can tell you that even the dirtiest Chinese takeout joint ( and I have eaten at thousands of them) serves excellent fare, sometimes with produce that the local farmers sell right off the dirty sidewalk.

    What matters is that their food preparation habits are in fact quite clean. And, many of those farmers at least can make a living selling things on the street, unlike in the US where that is criminalized or pathologized.

    You are so right about the homeless. Are you aware that the tension between the corporate/church/NGOs such as Salvation Army, Catholic Charities, etc. is caused by the US binary (bi-polar) narrative where churches compete with secular initiatives for project funding?

    Its really just a pitched battle for who will get the the real estate and the federal/state matching funds, to build a shelter.

    Then, throw in the psychiatric meta-narrative where every person who sleeps out doors must be crazy or a criminal and then the police, jails, medical facilities who derive massive profits every time they lock these guys up, etc.

    Its racketeering and a form of peonage/slavery at a different, but modern level. US is so broken, lol.

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


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