Gilead to start limiting access to remdisivir?

They probably aren't prepared for commercial scale manufacturing.

I can't read behind the paywall, do they describe why?

Copy and paste the article pls.

The drug was still in development so the quantity has been limited.

Nothing like that at all. It's all about profit. This is as far from a rare disease as you can get. There's a loophole that if you can rush to get rare disease status before the number of cases reaches the threshold then you get grandfathered in. This is shameful to me and exploits a law that has a purpose, but this is not that purpose

https://www.google.com/amp/s/mobile.reuters.com/article/amp/idUSKBN21A3PR

Doesn't surprise me at all that a drug manufacturer would exploit the system to maximize profits, even in a crisis.

However, until there is sufficient evidence that shows that this actually improves outcomes, and specifically improves morbidity and morality, we should not be rushing make this a standard treatment. That's not how medicine works, and not how it should work. I understand in a crisis you get more freedom in how to do things, but what if you put all your money in on this treatment and it turns out later that it does only helps people that would've survived anyways? Or maybe it does nothing or minimally helps, and something else out there could've done more?

The same applies to hydrloxychloroquine, which people actually need for other reasons and there's currently a shortage of an otherwise very available med.

1) Orphan drug status streamlines the approval practice. This is taking advantage of a legislative loophole to cram in a pragmatic potential solution. If mislabeling this as an orphan drug cuts a bunch of red tape, I don't see how that is a bad thing.

2) One thing Gilead is doing is asking people who want compassionate access to the drug is to sign up for the phase III clinical trials. I don't see how this is a bad thing either. It gets more people to participate in getting good data on efficiency, and limits the distribution of the drug to specific cases.

Not critical of either move. Both seem to be to trying to get an effective treatment on the market ASAP, which could save the entire world economy.

https://www.google.com/amp/s/amp.usatoday.com/amp/2934583001

Thankfully they disagreed with you. This was a money grab pure and simple, and absolutely shameless to apply for, and be granted orphan drug status. We don't know if the drug will be effective, but if it is then Gilead will still make good profits off royalties. They were trying to make returns measured in the 1000s of % in the middle of a worldwide pandemic. Frustrating because the pharmaceutical industry is doing heroic work, and some greedy execs gave the uninformed public the excuse to keep hating big pharma.

Thought this was about Handmaids Tale

jt16 said:

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https://www.google.com/amp/s/amp.usatoday.com/amp/2934583001

Thankfully they disagreed with you. This was a money grab pure and simple, and absolutely shameless to apply for, and be granted orphan drug status. We don't know if the drug will be effective, but if it is then Gilead will still make good profits off royalties. They were trying to make returns measured in the 1000s of % in the middle of a worldwide pandemic. Frustrating because the pharmaceutical industry is doing heroic work, and some greedy execs gave the uninformed public the excuse to keep hating big pharma.

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Your source says " There was such an outcry against what many called profiteering that Gilead made the rare decision to ask the FDA to rescind the status." so it sounds as if the orphan drug status is going away.

The article says they were having so many requests they had to briefly halt requests to revamp their approval process.

jt16 said:

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https://www.google.com/amp/s/amp.usatoday.com/amp/2934583001

Thankfully they disagreed with you. This was a money grab pure and simple, and absolutely shameless to apply for, and be granted orphan drug status. We don't know if the drug will be effective, but if it is then Gilead will still make good profits off royalties. They were trying to make returns measured in the 1000s of % in the middle of a worldwide pandemic. Frustrating because the pharmaceutical industry is doing heroic work, and some greedy execs gave the uninformed public the excuse to keep hating big pharma.

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When you say 1000's of %, is that on manufacturing, or manufacturing+R&D+Testing? Most big pharma critics, and journalists, like to look solely at the pierce to manufacture a pill or doses and take a percentage from price. It's a willfully ignorant take.

Also, if they don't make anything on this, it might as well be just another bust where they spent a bunch of money on development that didn't pan out. The profit from a single drug goes to find the losses on R&D for many others.

Orphan drug status is about rewarding a company for putting money into R&D that they are not otherwise likely to recoup.

FDA definition for rare disease:

Quote:

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• Affects less than 200 000 individuals in the USA ;
• Affects more than 200 000 individuals in the USA without it being possible to cover the cost of development and distribution by sales on national territory.

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With the likes of Bernie Sanders and others saying that a COVID-19 treatment should be available to all for no cost, I see no problem with granting potential therapies orphan drug status and providing them with the benefits that come with that (if the drug proves itself and is then approved.) The benefits to the developing company include:

• a 50% tax credit on the cost of clinical trials undertaken in the USA; --> I would support this as a means to encourage quick action during this pandemic and providing access to US patients to the potential therapy in a clinical trial setting
• a seven year period of marketing exclusivity following the marketing approval; --> this is the piece that most seem to be hung up on
• some written recommendations provided by the FDA concerning clinical and preclinical studies to be completed in order to register the new drug ; --> this is huge for pharma companies, it's additional interaction with the agency during the product development to ensure your studies will answer the question the FDA wants answered
• a fast-track procedure for the FDA to evaluate registration files ; --> no one should argue with this one either

NawlinsAg01 said:

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Orphan drug status is about rewarding a company for putting money into R&D that they are not otherwise likely to recoup.

FDA definition for rare disease:

Quote:

---

• Affects less than 200 000 individuals in the USA ;
• Affects more than 200 000 individuals in the USA without it being possible to cover the cost of development and distribution by sales on national territory.

---

With the likes of Bernie Sanders and others saying that a COVID-19 treatment should be available to all for no cost, I see no problem with granting potential therapies orphan drug status and providing them with the benefits that come with that (if the drug proves itself and is then approved.) The benefits to the developing company include:

• a 50% tax credit on the cost of clinical trials undertaken in the USA; --> I would support this as a means to encourage quick action during this pandemic and providing access to US patients to the potential therapy in a clinical trial setting
• a seven year period of marketing exclusivity following the marketing approval; --> this is the piece that most seem to be hung up on
• some written recommendations provided by the FDA concerning clinical and preclinical studies to be completed in order to register the new drug ; --> this is huge for pharma companies, it's additional interaction with the agency during the product development to ensure your studies will answer the question the FDA wants answered
• a fast-track procedure for the FDA to evaluate registration files ; --> no one should argue with this one either

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Orphan status is used to incentivize drug companies to design drugs for rare diseases that they would otherwise not invest in. That's why there are guidelines of 200,000 people. There isn't anyone on this planet that thinks this will meet that hurdle. If this drug works, the drug will be used extensively for years. They'll recoup their investment many times over. The FDA can, and is, fast tracking development independent of orphan status. Orphan status isn't required for that to happen. I really don't see how anyone can see this as anything other than a money grab at the worst possible time. Thankfully the company realized this and is doing the right thing. Gilead, and all drug companies should take advantage of orphan status, and all the things you mentioned above where it makes sense. You know, when there is literally no money being invested on something because lack of a return. This is as far from that as you can get.

You realize the company took government money to help develop the drug in the first place right?