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. This comment has been flagged by the community. Click here to show it
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    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.


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