Yes, I understand. What I am suggesting is that it would be better for the public if the FDA was only concerned about safety, and let others decide the issue of efficacy. This is especially relevant since efficacy might vary depending on the population involved. Age, sex, or normal variability in response might affect how efficacious a d…
Yes, I understand. What I am suggesting is that it would be better for the public if the FDA was only concerned about safety, and let others decide the issue of efficacy. This is especially relevant since efficacy might vary depending on the population involved. Age, sex, or normal variability in response might affect how efficacious a drug is in a particular situation, and the variability in experienced side effects might also be different. What would be the argument for the FDA requiring proof of efficacy before granting approval?
I'm not sure I understand your question. The new drug approval process is already incredibly expensive. If new drugs had to make there way through TWO bumbling, disorganized, inefficient bureaucracies before receiving approval it would make them even more expensive than they are now. I agree that safety trumps efficacy, but I don't know you one could check for both without creating another bureaucracy to do so.
Let me try again. Why check for efficacy? Why not ONLY check for safety? It would eliminate the most expensive part of the current FDA procedure and make drugs approvals easier and quicker as well as eliminate the FDA deciding trade-offs between safety and efficacy. Half the bureaucracy not twice.
In the case of the Covid vaccines, it's not clear that they really checked for either safety or efficacy. I guess with an EUA it doesn't seem to matter.
Yes, I understand. What I am suggesting is that it would be better for the public if the FDA was only concerned about safety, and let others decide the issue of efficacy. This is especially relevant since efficacy might vary depending on the population involved. Age, sex, or normal variability in response might affect how efficacious a drug is in a particular situation, and the variability in experienced side effects might also be different. What would be the argument for the FDA requiring proof of efficacy before granting approval?
I'm not sure I understand your question. The new drug approval process is already incredibly expensive. If new drugs had to make there way through TWO bumbling, disorganized, inefficient bureaucracies before receiving approval it would make them even more expensive than they are now. I agree that safety trumps efficacy, but I don't know you one could check for both without creating another bureaucracy to do so.
Let me try again. Why check for efficacy? Why not ONLY check for safety? It would eliminate the most expensive part of the current FDA procedure and make drugs approvals easier and quicker as well as eliminate the FDA deciding trade-offs between safety and efficacy. Half the bureaucracy not twice.
In the case of the Covid vaccines, it's not clear that they really checked for either safety or efficacy. I guess with an EUA it doesn't seem to matter.
I suppose if we did that Big Pharma would focus totally on safety and the drugs would be useless, but safe. Somehow efficacy needs to be established.