https://www.google.com/amp/s/amp.washingtontimes.com/news/2020/apr/2/hydroxychloroquine-rated-most-effective-therapy-do/

Cant Think of a Name said:

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Longer term, we would want to be to a point where you could get testing on demand at the start of symptoms, and give hcq and zpac the same way we give tamiflu for a positive flu test. Once we get there, then this isn't a major problem anymore.

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This is the end game. With essentially temporary government takeover of manufacturing under the Defense Production Act, why cant there be stacks of this stuff in every walgreens and cvs in america in a month or less? Then just start mass perscribing itl to everyone with a cough. Then we can all go back to work! What am i missing here?

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It's not that easy in pharma. If the tablets are manufactured at a site that has fixed capacity, you just can't start on-boarding new manufacturing sites to make the dosage forms. There's the tech transfer to the site including the qualification and validation of the manufacturing method and the transfer and qualification/validation of the analytical methods that will be used to test the quality of the drug and release it to the market. There is also a minimum amount of stability data that you would like to have to ensure the quality of the drug going to the market (e.g., that the shelf life is not compromised by switching to another manufacturing site). Not to mention the bioequivalence studies that would need to be performed in humans to ensure that dosage forms made at one site are similar to dosage forms made at the original site.

A lot of what I mentioned above is covered by FDA guidance on Scale-Up and Post-Approval Changes (SUPAC) as well as FDA guidances on Abbreviated New Drug Product Applications (ANDA's).

Now, if you have a large generic manufacturer such as Perrigo, Sandoz, Mylan, or Teva that are already manufacturing the drug, then it would be much easier to increase their capacity by mandating in an emergency that they increase the output of these drugs by diverting resources from other drugs they manufacture. But it's a totally different animal from Ford or GM making ventilators or My Pillow making PPE.

queso1 said:

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I wonder if we had these requirements when we had women making bombs during WW2. There comes a point when you have to consider that government regulations are hampering an effort and just say "**** it."

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Everything I mentioned above is in the Code of Federal Regulations (CFR's). Like I said, it's a totally different animal.
My last paragraph would be the best chance at increasing production.

queso1 said:

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I completely understand. I'm just wondering if we reach a point where we bypass the CFR to save lives and to get the economy back and running.

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FDA has a very good idea of the number of producers for these branded and generic meds (both stateside and offshore) and likely have an idea of what their max output could be. There would have to be some seriously extenuating circumstances and strong proof from clinical trials (not anecdotal) for FDA to give away their power like that.

Cant Think of a Name said:

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Like a plague that is crippling our economy and threatens our very way of life?

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Can't answer that question, unfortunately.

Aggie Pharmer said:

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Cant Think of a Name said:

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Quote:

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Longer term, we would want to be to a point where you could get testing on demand at the start of symptoms, and give hcq and zpac the same way we give tamiflu for a positive flu test. Once we get there, then this isn't a major problem anymore.

---

This is the end game. With essentially temporary government takeover of manufacturing under the Defense Production Act, why cant there be stacks of this stuff in every walgreens and cvs in america in a month or less? Then just start mass perscribing itl to everyone with a cough. Then we can all go back to work! What am i missing here?

---

It's not that easy in pharma. If the tablets are manufactured at a site that has fixed capacity, you just can't start on-boarding new manufacturing sites to make the dosage forms. There's the tech transfer to the site including the qualification and validation of the manufacturing method and the transfer and qualification/validation of the analytical methods that will be used to test the quality of the drug and release it to the market. There is also a minimum amount of stability data that you would like to have to ensure the quality of the drug going to the market (e.g., that the shelf life is not compromised by switching to another manufacturing site). Not to mention the bioequivalence studies that would need to be performed in humans to ensure that dosage forms made at one site are similar to dosage forms made at the original site.

A lot of what I mentioned above is covered by FDA guidance on Scale-Up and Post-Approval Changes (SUPAC) as well as FDA guidances on Abbreviated New Drug Product Applications (ANDA's).

Now, if you have a large generic manufacturer such as Perrigo, Sandoz, Mylan, or Teva that are already manufacturing the drug, then it would be much easier to increase their capacity by mandating in an emergency that they increase the output of these drugs by diverting resources from other drugs they manufacture. But it's a totally different animal from Ford or GM making ventilators or My Pillow making PPE.

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I believe 10 generic manufacturers are approved. The availability of doses will most likely depend on the availability of API vs the availability of manufacturing capacity. The larger generic sites have capacity to make billions of doses per year. Also, this is an immediate release formulation which is much easier to transfer the manufacturing and testing processes among sites.

pbrancazio said:

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Aggie Pharmer said:

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Cant Think of a Name said:

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Quote:

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Longer term, we would want to be to a point where you could get testing on demand at the start of symptoms, and give hcq and zpac the same way we give tamiflu for a positive flu test. Once we get there, then this isn't a major problem anymore.

---

This is the end game. With essentially temporary government takeover of manufacturing under the Defense Production Act, why cant there be stacks of this stuff in every walgreens and cvs in america in a month or less? Then just start mass perscribing itl to everyone with a cough. Then we can all go back to work! What am i missing here?

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It's not that easy in pharma. If the tablets are manufactured at a site that has fixed capacity, you just can't start on-boarding new manufacturing sites to make the dosage forms. There's the tech transfer to the site including the qualification and validation of the manufacturing method and the transfer and qualification/validation of the analytical methods that will be used to test the quality of the drug and release it to the market. There is also a minimum amount of stability data that you would like to have to ensure the quality of the drug going to the market (e.g., that the shelf life is not compromised by switching to another manufacturing site). Not to mention the bioequivalence studies that would need to be performed in humans to ensure that dosage forms made at one site are similar to dosage forms made at the original site.

A lot of what I mentioned above is covered by FDA guidance on Scale-Up and Post-Approval Changes (SUPAC) as well as FDA guidances on Abbreviated New Drug Product Applications (ANDA's).

Now, if you have a large generic manufacturer such as Perrigo, Sandoz, Mylan, or Teva that are already manufacturing the drug, then it would be much easier to increase their capacity by mandating in an emergency that they increase the output of these drugs by diverting resources from other drugs they manufacture. But it's a totally different animal from Ford or GM making ventilators or My Pillow making PPE.

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I believe 10 generic manufacturers are approved. The availability of doses will most likely depend on the availability of API vs the availability of manufacturing capacity. The larger generic sites have capacity to make billions of doses per year. Also, this is an immediate release formulation which is much easier to transfer the manufacturing and testing processes among sites.

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I agree with this 100%. I wasn't considering the availability of raw materials in my response, but you are correct. This would be my #1 concern right now because you would basically be competing with every other in the country in the work for available API to produce your tablets.

These drugs are proven safe enough. Don't take if you don't want to but don't deny to others.

We are spending Trillions of $ and the economy is getting destroyed.

We should spend a large portion of that money and resources getting these meds out to every American and get back to work right away. If it only helps 10% of the population that is a giant win. Companies are donating millions of pills which means millions more could be produced quickly. All these meds are generic.

Good grief the people worried about side effects in a tiny population issue is flat out ignorant. If your too scared to take the meds then don't. I for one will take them and head back to work today!! Everyone at risk should stay at home and self quarantine but we cant continue like this.

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You will likely be seeing commercial's in the near future were you give HCQ in the pandemic and suffered a heart arrhythmia, kidney damage, liver damage or vision damage you could be entitled to a cash settlement.

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And the same people willing to sue would take this drug in a heartbeat right now. I absolutely hate the fact that drug companies can be sued for doing a good thing 99% of the time.

I'm guessing most cardiologists are closed down for in office visits these days? Ptetty positive my "clinic" doesn't do EKGs to have a recent one available.

That's always how it works. You'll never see a dark green Chevy Tahoe. Dispatch broadcasts a BOLO for one and you'll see 15 in first 5 minutes

Aggie Pharmer said:

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Cant Think of a Name said:

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Quote:

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Longer term, we would want to be to a point where you could get testing on demand at the start of symptoms, and give hcq and zpac the same way we give tamiflu for a positive flu test. Once we get there, then this isn't a major problem anymore.

---

This is the end game. With essentially temporary government takeover of manufacturing under the Defense Production Act, why cant there be stacks of this stuff in every walgreens and cvs in america in a month or less? Then just start mass perscribing itl to everyone with a cough. Then we can all go back to work! What am i missing here?

---

It's not that easy in pharma. If the tablets are manufactured at a site that has fixed capacity, you just can't start on-boarding new manufacturing sites to make the dosage forms. There's the tech transfer to the site including the qualification and validation of the manufacturing method and the transfer and qualification/validation of the analytical methods that will be used to test the quality of the drug and release it to the market. There is also a minimum amount of stability data that you would like to have to ensure the quality of the drug going to the market (e.g., that the shelf life is not compromised by switching to another manufacturing site). Not to mention the bioequivalence studies that would need to be performed in humans to ensure that dosage forms made at one site are similar to dosage forms made at the original site.

A lot of what I mentioned above is covered by FDA guidance on Scale-Up and Post-Approval Changes (SUPAC) as well as FDA guidances on Abbreviated New Drug Product Applications (ANDA's).

Now, if you have a large generic manufacturer such as Perrigo, Sandoz, Mylan, or Teva that are already manufacturing the drug, then it would be much easier to increase their capacity by mandating in an emergency that they increase the output of these drugs by diverting resources from other drugs they manufacture. But it's a totally different animal from Ford or GM making ventilators or My Pillow making PPE.

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There is also the issue of the raw materials and the supply chain logistics

There is no chance the FDA green lights production at a manufacturing facility without the proper protocols being followed.