I’ve got a feeling when stupid or uninformed or those inclined to gamble people die from taking a highly experimental drug their families are going to turn around and sue.
The FDA needs to be more efficient and we just have to accept they’re not going to be 100% which means not trying to burn the FDA when they approve something that wasn’t quite there yet or never should have been approved. No system is perfect, but the fear of getting it wrong shouldn’t slam the system to a halt.
So many sensible things are not done due to fear of liability. I don’t know what you can do about it other than try to appoint reasonable judges.
I’m thinking the trick is being able to distinguish between protecting a valuable institution from screwing over the little guy in favor of entrenched interests. What it looks like to you probably depends a lot on which side of the table you are on. Even if you could figure out the objective, ‘greater good’ response, it is likely to come across as very cold to someone who’s lost a loved one.
And who is paying for this very expensive drug that’s in no way endorsed by any agency in this country. These last couple of examples are actually drugs the FDA approved and insurance is paying for. Your solution is to let these drugs be sold directly to the patient, insurance isn’t going to cover the experimental, and wouldn’t that just lead us back here where we get to discuss, again, how unfair it for patients to pay that much only this time we’re talking a drug that hasn’t completed the process. Are you saying we have to go to a single-payor system where the government will pay for anything and any amount as long as someone with a 10% survival rate thinks they’re get 15% if they try this 10k a month drug?
If the FDA is not serving it’s purpose or that purpose is not well defined, I would say we have to fix it and make the judges more reasonable and efficient. It’s not their job to protect the pharm companies. Their interest should be aligned with the public and facts. It’s the job of the pharm companies to consider profit and shareholders, not the FDA.
You would expect that, sure, but I don’t think most people realize the full cost of a drug. We’ll be right back here in a year or two after such a change talking about how unfair it is one rich person gets this life saving drug and how the poor are left out. The rich can also fly to another country and get it anyway today so we’re just helping the upper-middle class then to front the drug but not the travel. What do we do if they start taking the drug and the FDA says no it’s not safe… let the drug company continue selling it outside of the health industry… sort of. I assume the physician will still prescribe it and the pharmacist still offer it. it almost creates a kind of grey market doesn’t it? I am not opposed to the idea. I know back when AIDS was just a death sentence they were denied options and basically just told to wait and die early on.
What right would this be? What right are we talking about? Be specific because I don’t have a right to buy whatever I want right now. There’s a long list of illegal drugs and items I can’t buy based on Federal and State laws.
I’ve completely lost the thread here. Why are we talking about people being allowed to take non-FDA approved drugs? That idea is a complete non-starter. For reasons of legal liability no drug company would allow such sales and no physician would prescribe such drugs.
The link is the FDA process itself may be causing some issues as to why something like the EpiPen doesn’t have a great competitor, and the competition it does have can’t be listed as a generic. There was also an article floating around saying how it’s safer for the FDA to drag its feet and not approve drugs or approve them slowly than accidentally approve one it shouldn’t have. One they’re held to a lot more accountability than the other.
I believe the suggested option in that article is a bit too far to swing the pendulum. I think almost all of us agree that changes are needed, however. I’d argue that some way to “magically” expand drug trials would be best (it would require magic/subsidization from taxes, because it would otherwise add significant cost to pharmaceutical companies). With drug trials, there’s extensive follow up and a vested interest to make sure everything goes well. In addition, it will be excruciatingly clear to the participants that what they’re taking is a trial drug and not fully vetted for widespread use as they’ll have to sign a bunch of waivers in the process.
The right you speak of doesn’t actually exist, so it’s really more of a wish than a right. I realize the Libertarian party keeps pushing these ideals, but they’re not even in the running in most races or even on many issues.
You might think if you remove the FDA you’re just removing a barrier, and if you reduce or remove government in healthcare insurance that solves the problem too. Except this private insurance company could charge whatever they want, whether it’s 750 out of pocket for a drug that helps a fraction of the population or a 600 out of pocket charge for an EpiPen that can save thousands of lives a year.
No… I’m pretty sure that is in fact a right. You could theoretically try and argue that it isn’t codified in the US Constitution, but even there i think an argument could be made. For instance, why are you allowed to have an abortion?
It’s because your right to privacy extends to give you control over your own body. I would argue that, likewise, i have the same right to do what i see fit to my own body.
In terms of being able to purchase commodities that do not harm others, i would argue that such a right stems from basic property rights, where I have ownership of my own property and am able to engage in free commerce and economic contracts with whomever i choose. And in cases like drug laws, i do not believe that what is gained (which is, empirically, nothing) does not justify the restriction on rights it requires.
You may think that such rights don’t matter, but then i would suspect that you don’t have a very deep understanding of any rights at all beyond simple dogma.
Sure, you have rights to do what you want. I don’t think anyone is saying you can’t perform experimental medical treatments on yourself. I think people are suggesting that government agencies staffed with people who presumably have a great deal more expertise than the general public can and should regulate what treatments are made commercially available to the general public.
I think dragging recreational drug laws into the conversation just muddies it. Whole different set of circumstances vs medical treatments.
I certainly can’t speak for Nesrie, but my opinion is that Nesrie seems to be a well informed individual. I’d like to humbly suggest that closing a post with “agree with me or admit you don’t understand” is not conducive to discussion.
I’m not sure why it is so baffling. I mean, if you were given such a choice, what would you do? Would you do take a bunch of uncertified drugs? No, not likely.
Indeed, i don’t really think this is much of a solution to something like an epipen, perhaps, although at the same time we’re taking about a generic. FDA approval may not really be necessary to know that a generic epipen would perform identically based on its chemical composition, right? I’m not certain their required processes for generic versions of drugs really make sense.
But that’s separate from what i was taking about, which was experimental drugs. In a case where a drug has yet to be approved, a consumer should be able to take that chance as long as it’s made clear that it is not certified yet. I don’t believe that the government should be able to prevent them.
Well, but no, you can’t really do that. The only time you could take drugs which were unapproved, I believe, is in the context of government regulated drug trials.
Well, it was bright up by nesrie, so i explained the rationale for why such usage actually should be legal, and thus how it’s illegality isn’t a legitimate argument for the government restricting use of prescription drugs.
If you don’t believe that being able to engage in economic transactions freely, or controlling your own body, are important fundamental pillars of all rights, then I’m sorry, i have to say that your understanding of rights is based on dogma.
Without those fundamental pillars, you don’t really have much left to base anything on.
People are not individually qualified to decide if a treatment is safe. That’s why we hold to doctors the power to prescribe any drugs more potent than Advil.
Drug companies are insulated from the legal liability of drug side effects or misuse by the FDA approval process. That certifies a drug with known effects and known risks and puts the onus on the prescribing doctors to use it appropriately. Without that protection the companies won’t put stuff on sale even if they legally could. They’d get sued to oblivion the first time someone got hurt or killed by going youtube and finding a quack preaching about alternative dosages or off label uses or whatnot.
Same as 2, but instead of drug companies substitute doctors. Who would also be afraid of being sued into oblivion by unintended side effects.
So basically, it’s a bad idea for individuals to be allowed access to uncertified drugs, it’s a bad idea of doctors, and a bad idea for drug companies. When a proposal seem to have trial lawyers as a sole beneficiary I’m a bit leery of whether it’s really a good idea.
If you don’t believe that you have a right to your own body or property, then what are you basing your notion of rights upon?
In truth, does anyone here actually disagree with that assertion? That we have rights to control our own bodies and property? And if you do, then what do you believe we DO have rights over? And upon what are those rights based, if not dogma?