3 ms·

It doesn't for many known medications. But, it's a factor for new and less well understood medications. There is "on label" and "off label" usage of drugs. Jus

It doesn't for many known medications. But, it's a factor for new and less well understood medications. There is "on label" and "off label" usage of drugs. Just because this existing medication is being used in the EU, or has made its way into guidelines, does not mean that it would even make it through EU approvals. It's being used "off label" if it's used for a new condition. I've personally been treated "off label" for a condition using a drug developed and FDA approved for a serious condition that you wouldn't immediately associate with my condition. It was weird being unable to find any substantive literature on that medication and my condition, but that's the nature of uncommon conditions, or being at the edge like we are with COVID-19. US doctors will, based on the evidence available, make their own decision on whether to follow the treatments used by their colleagues in the EU and China. They are not going to be held up by FDA approval for off-label use, but they may find things that warrant FDA review and approval because they feel the outcome is not worth the risk. The impact on the US is trailing China and EU to some degree. This buys a little time for some very smart people to do some level of analyses of what's happening elsewhere. It'd be a little different if the early waves hit here first.

gnulinux 7y ago
So a US doctor doesn't need FDA approval to be able to prescribe something like chloroquine or Remdesivir for a COVID19 patient as long as they believe it'll be helpful to patient, did I understand it correctly?
- zerkten 7y ago
  Yes, but in practice it is rarely the situation where a doctor is making this call on their own. The hierarchy from doctor to senior leadership should be involved in decisions like this because there are many more ramifications than just one patient. From the doctor's perspective, at minimum this is a cover-your-ass move because they don't want to get blamed for an adverse event. The administration needs to manage the risk too, and find other experts to review the situation. They may also need to manage supplies, or costs. This is really no different from the usual medical bureaucracy in the US. One item that I'll end with is that approval processes (FDA, EU, etc.) provide no guarantees. There are many drugs that have been approved and then removed from general use based on additional experience, or long-term clinical trials. It's obviously good to do more trials and get approvals, but patients and doctors really want the best possible outcome given the situation.

gnulinux 7y ago

So a US doctor doesn't need FDA approval to be able to prescribe something like chloroquine or Remdesivir for a COVID19 patient as long as they believe it'll be helpful to patient, did I understand it correctly?

zerkten 7y ago
Yes, but in practice it is rarely the situation where a doctor is making this call on their own. The hierarchy from doctor to senior leadership should be involved in decisions like this because there are many more ramifications than just one patient. From the doctor's perspective, at minimum this is a cover-your-ass move because they don't want to get blamed for an adverse event. The administration needs to manage the risk too, and find other experts to review the situation. They may also need to manage supplies, or costs. This is really no different from the usual medical bureaucracy in the US. One item that I'll end with is that approval processes (FDA, EU, etc.) provide no guarantees. There are many drugs that have been approved and then removed from general use based on additional experience, or long-term clinical trials. It's obviously good to do more trials and get approvals, but patients and doctors really want the best possible outcome given the situation.