3 ms·

You are right about the current role. But I think the frustration with the FDA comes from their textbook following of the rules without any apparent concern for

You are right about the current role. But I think the frustration with the FDA comes from their textbook following of the rules without any apparent concern for trade-offs beyond their immediate purview. Their algorithm for decision making is limited and that leads to uncreative decisions. My personal frustration with them has been their slowness to approve vaccines (and to do common sense things like offer boosters or lower doses for those who want them) because it goes against procedure written years ago for illnesses that are not time-dependent at all.

refurb 5y ago
Your frustration is they "follow rules"? I mean their role was created by law and if they overstep it, it gets shut down. For example, the FDA can't say "we're not approving this drug because the price is too high". That's not in their mandate and if they did do it, they'd pretty quickly get sued and forced to approve the drug. And slowness in approving vaccines? The FDA was one of the first globally to approve the Covid vaccines (I think the UK was first). And nothing stops your doctor from giving you a vaccine booster right now. In fact, I believe many people are getting them. The FDA does not dictate how drugs can be used once approved - that's at a doctors discretion.
- handmodel 5y ago
  The FDA is making the rules that the only way to take a vaccine is by their approval. By FDA rules, there is no in-between of being illegal to administer and being recommended (aka no "up to you" zone) Right now, for instance, they are conducting tests on a couple thousand 11 year olds even though we have data on millions of 12 year olds. Data from the 12 year olds will not be used to determine if it is safe for 11 year olds. If you are a parent of an 11 year old not only is the vaccine not recommended - you are now allowed to get it. I am saying the FDA should allow more flexibility instead of demanding to be the arbiter of every decision. They want, however, to be the arbiter of every decision because it makes them more integral to the system.
nradov 5y ago
If the FDA prematurely approved a vaccine which was later found to have serious side effects that would destroy public confidence in vaccines for generations. Be patient.
- derbOac 5y ago
  So here's the thing: the FDA has already given full approval to the vaccine. They've approved it. And yet, somehow we're still having this discussion about whether it's ok to give a third dose, after several months, despite good evidence that doing so would often be helpful. We can argue about the data, but a reasonable person, looking at the data, could come to the conclusion that there is good reason to give a third dose of a vaccine the FDA has already approved. So where's the ability of physicians to exercise their expert discretion? Why are we even having this discussion? Contrast this with the opioid epidemic, where lives and communities were being destroyed wholesale. Why wouldn't it be appropriate for the FDA to step in and temporarily put greater restrictions on the medications? They regulated dispensation of pseudoephedrine and do all sorts of things. Why not do it with opioids? When there's actual serious harm, the FDA shouldn't do anything because the drug has some legitimate uses sometimes, but when there's evidence of very little harm, the FDA should leverage its complete authority to prevent it, despite evidence it might be of public health benefit? I can give other examples of drugs where in the peer-reviewed literature there are review articles concluding that a medication is completely safe to be offered over-the-counter, but conclude that it shouldn't be so as to not establish a precedent. The problem is this inconsistency: what real authority -- not legally inherited authority, but actual authority, in the sense of moral authority -- does the FDA have if it bans substances like cannabis, all the while allowing alcohol (which has much more serious consequences), letting an opioid crisis burn like wildfire, and then putting the hammer down on a third dose of a pharmaceutical it has already approved? Think of it this way: is it any wonder there are so many vaccine skeptics when the FDA behaves as if a third dose of a vaccine it has already approved is so dangerous physicians shouldn't be allowed to use their discretion to prescribe it? It's no surprise that there's such a crisis of skepticism about expertise in this country. The credentialing associated with the expertise is empty of meaning anymore, and it is constantly overstepping its role.

refurb 5y ago

Your frustration is they "follow rules"? I mean their role was created by law and if they overstep it, it gets shut down. For example, the FDA can't say "we're not approving this drug because the price is too high". That's not in their mandate and if they did do it, they'd pretty quickly get sued and forced to approve the drug. And slowness in approving vaccines? The FDA was one of the first globally to approve the Covid vaccines (I think the UK was first). And nothing stops your doctor from giving you a vaccine booster right now. In fact, I believe many people are getting them. The FDA does not dictate how drugs can be used once approved - that's at a doctors discretion.

handmodel 5y ago
The FDA is making the rules that the only way to take a vaccine is by their approval. By FDA rules, there is no in-between of being illegal to administer and being recommended (aka no "up to you" zone) Right now, for instance, they are conducting tests on a couple thousand 11 year olds even though we have data on millions of 12 year olds. Data from the 12 year olds will not be used to determine if it is safe for 11 year olds. If you are a parent of an 11 year old not only is the vaccine not recommended - you are now allowed to get it. I am saying the FDA should allow more flexibility instead of demanding to be the arbiter of every decision. They want, however, to be the arbiter of every decision because it makes them more integral to the system.

nradov 5y ago

If the FDA prematurely approved a vaccine which was later found to have serious side effects that would destroy public confidence in vaccines for generations. Be patient.

derbOac 5y ago
So here's the thing: the FDA has already given full approval to the vaccine. They've approved it. And yet, somehow we're still having this discussion about whether it's ok to give a third dose, after several months, despite good evidence that doing so would often be helpful. We can argue about the data, but a reasonable person, looking at the data, could come to the conclusion that there is good reason to give a third dose of a vaccine the FDA has already approved. So where's the ability of physicians to exercise their expert discretion? Why are we even having this discussion? Contrast this with the opioid epidemic, where lives and communities were being destroyed wholesale. Why wouldn't it be appropriate for the FDA to step in and temporarily put greater restrictions on the medications? They regulated dispensation of pseudoephedrine and do all sorts of things. Why not do it with opioids? When there's actual serious harm, the FDA shouldn't do anything because the drug has some legitimate uses sometimes, but when there's evidence of very little harm, the FDA should leverage its complete authority to prevent it, despite evidence it might be of public health benefit? I can give other examples of drugs where in the peer-reviewed literature there are review articles concluding that a medication is completely safe to be offered over-the-counter, but conclude that it shouldn't be so as to not establish a precedent. The problem is this inconsistency: what real authority -- not legally inherited authority, but actual authority, in the sense of moral authority -- does the FDA have if it bans substances like cannabis, all the while allowing alcohol (which has much more serious consequences), letting an opioid crisis burn like wildfire, and then putting the hammer down on a third dose of a pharmaceutical it has already approved? Think of it this way: is it any wonder there are so many vaccine skeptics when the FDA behaves as if a third dose of a vaccine it has already approved is so dangerous physicians shouldn't be allowed to use their discretion to prescribe it? It's no surprise that there's such a crisis of skepticism about expertise in this country. The credentialing associated with the expertise is empty of meaning anymore, and it is constantly overstepping its role.