4 ms·

I will admit that some of us may be inappropriately dismissive of the usefulness of regulators. However pointing to how long it takes and how much money is spen

I will admit that some of us may be inappropriately dismissive of the usefulness of regulators. However pointing to how long it takes and how much money is spent could just as well imply inefficiency as rigor. You say that we don't need competing regulation agencies because this one is rigorously scientific. By what mechanism, would you say, does this singular institution maintain quality?

criley2 9y ago
>By what mechanism, would you say, does this singular institution maintain quality? Interesting question, quality is such a foundationally important and vital subject for the FDA. Hard to answer, it's like asking what does Microsoft do to maintain software quality? The answer has to be long and in depth... And in this case, the FDA is over 100 years old, born out of atrociously horrendous food and chemical accidents in America, so this is a century-old organization founded out of a desire to improve quality in food and drugs (Upton Sinclair's 1906 book The Jungle is considered important reading when understanding the FDA's mission) So with the FDA (with CDER, the drug/med device/biologic/etc side of the FDA), the basic question they ask (and require all this work to prove is): Is your drug better than existing treatments and placebo treatments? So, fundamentally, they have an ethos which only grants approval not for equivalence, but scientifically proven, double blind tested superiority to existing approvals. This is an ethos that less is more. That only quality matters. That a business should go bankrupt before 1 bad drug is approved. But beyond that, to look into the question of quality, that's a great question that is very important to the core of the FDA's mission. I would point, in recent decades to the emergence of "phase 4" trials -- post-release trials. Now it is not enough to get approved, now we continue to test the efficacy and safety of the drug after it goes to market, and can and have pulled drugs (that cost billions in losses for companies) which seem to pass initial 3 phase approval but which, in market, demonstrates a lack of safety or efficacy, has side effects that change the calculus against existing treatments, or similar. Also, another angle of quality is enforcement. What happens if GLP, GMP, safety, efficacy, is violated? You might be happy to learn that the fines that the FDA levies are some of the largest fines against businesses in history. Outside of BP-Gulf and the 2008 mortgage fines, the FDA sweeps the list of billion-dollar-level fines. So you have a core commitment to quality at every level. An ethos continued from founding seeking scientifically provable superior quality at every judgement. GLP and GMP in the labs and factories which are the most rigorous site regulation you'll find in America. The 4 phase system of trials, including post-market data. And the most aggressive corporate enforcement arm in America, with an impressive list of profit-busting fines that no other regulator can stand next to.
- orblivion 9y ago
  I appreciate the long response, and I kind of feel bad because I meant my question in a rather different way. And (assuming you even notice my response at this point) perhaps I'm going to take us down a road of talking past each other. My question is about incentives. An unchallenged organization, I would think, would have the tendency to perpetuate itself, and sing its own praises, and deem itself very important. Let me put it this way: The analogous question isn't what Microsoft does to maintain quality. The question is, how does the world at large maintain Microsoft's quality (and efficiency?). A decade or so of security embarrassments and OSX's and Linux's better reputation got them to step up their security game. Recently, Apple's design got them to step up their design game. If you asked a manager for a canceled project inside the company they might have a great process plan, a great argument for why they need more time and resources, and a great explanation for why they and their team are important. But they may have no sense of the needs of the outside world. This exchange between Steve Jobs and an (apparent) Apple employee highlights this mentality, vs the mentality of an entrepreneur who does respond to the outside world: https://www.youtube.com/watch?v=FF-tKLISfPE https://www.youtube.com/watch?v=FF-tKLISfPE It very well may be that the FDA does a fantastic job of filtering out bad stuff. And, as (I may as well come out and say it) a libertarian, perhaps I am guilty of not appreciating all the work that has gone into setting it up. But it doesn't mean that they have a sense of the correct amount of rigor to apply, money to spend on various aspects of their operation, etc. That's why we like to see competition in the field of certification. "That a business should go bankrupt before 1 bad drug is approved." and "some of the largest fines against businesses in history" are great examples of perhaps being a bit too rigorous or punitive. You can always apply more and get at least marginally safer drugs. But you may also get fewer drugs through the process, or more expensive drugs, or companies that decide not to even bother starting the process (which you'll never hear about), and (maybe) more people die on net as a result. I will grant to you, taking your claims at face value, that you make a convincing case that the FDA at least hasn't gotten lax for the lack of outside corrective influence. I guess the mechanism for improvement there is simply human dedication, and I will buy that argument.

criley2 9y ago

>By what mechanism, would you say, does this singular institution maintain quality? Interesting question, quality is such a foundationally important and vital subject for the FDA. Hard to answer, it's like asking what does Microsoft do to maintain software quality? The answer has to be long and in depth... And in this case, the FDA is over 100 years old, born out of atrociously horrendous food and chemical accidents in America, so this is a century-old organization founded out of a desire to improve quality in food and drugs (Upton Sinclair's 1906 book The Jungle is considered important reading when understanding the FDA's mission) So with the FDA (with CDER, the drug/med device/biologic/etc side of the FDA), the basic question they ask (and require all this work to prove is): Is your drug better than existing treatments and placebo treatments? So, fundamentally, they have an ethos which only grants approval not for equivalence, but scientifically proven, double blind tested superiority to existing approvals. This is an ethos that less is more. That only quality matters. That a business should go bankrupt before 1 bad drug is approved. But beyond that, to look into the question of quality, that's a great question that is very important to the core of the FDA's mission. I would point, in recent decades to the emergence of "phase 4" trials -- post-release trials. Now it is not enough to get approved, now we continue to test the efficacy and safety of the drug after it goes to market, and can and have pulled drugs (that cost billions in losses for companies) which seem to pass initial 3 phase approval but which, in market, demonstrates a lack of safety or efficacy, has side effects that change the calculus against existing treatments, or similar. Also, another angle of quality is enforcement. What happens if GLP, GMP, safety, efficacy, is violated? You might be happy to learn that the fines that the FDA levies are some of the largest fines against businesses in history. Outside of BP-Gulf and the 2008 mortgage fines, the FDA sweeps the list of billion-dollar-level fines. So you have a core commitment to quality at every level. An ethos continued from founding seeking scientifically provable superior quality at every judgement. GLP and GMP in the labs and factories which are the most rigorous site regulation you'll find in America. The 4 phase system of trials, including post-market data. And the most aggressive corporate enforcement arm in America, with an impressive list of profit-busting fines that no other regulator can stand next to.

orblivion 9y ago
I appreciate the long response, and I kind of feel bad because I meant my question in a rather different way. And (assuming you even notice my response at this point) perhaps I'm going to take us down a road of talking past each other. My question is about incentives. An unchallenged organization, I would think, would have the tendency to perpetuate itself, and sing its own praises, and deem itself very important. Let me put it this way: The analogous question isn't what Microsoft does to maintain quality. The question is, how does the world at large maintain Microsoft's quality (and efficiency?). A decade or so of security embarrassments and OSX's and Linux's better reputation got them to step up their security game. Recently, Apple's design got them to step up their design game. If you asked a manager for a canceled project inside the company they might have a great process plan, a great argument for why they need more time and resources, and a great explanation for why they and their team are important. But they may have no sense of the needs of the outside world. This exchange between Steve Jobs and an (apparent) Apple employee highlights this mentality, vs the mentality of an entrepreneur who does respond to the outside world: https://www.youtube.com/watch?v=FF-tKLISfPE https://www.youtube.com/watch?v=FF-tKLISfPE It very well may be that the FDA does a fantastic job of filtering out bad stuff. And, as (I may as well come out and say it) a libertarian, perhaps I am guilty of not appreciating all the work that has gone into setting it up. But it doesn't mean that they have a sense of the correct amount of rigor to apply, money to spend on various aspects of their operation, etc. That's why we like to see competition in the field of certification. "That a business should go bankrupt before 1 bad drug is approved." and "some of the largest fines against businesses in history" are great examples of perhaps being a bit too rigorous or punitive. You can always apply more and get at least marginally safer drugs. But you may also get fewer drugs through the process, or more expensive drugs, or companies that decide not to even bother starting the process (which you'll never hear about), and (maybe) more people die on net as a result. I will grant to you, taking your claims at face value, that you make a convincing case that the FDA at least hasn't gotten lax for the lack of outside corrective influence. I guess the mechanism for improvement there is simply human dedication, and I will buy that argument.