5 ms·

The idea that we should all simply trust one entity to "approve" drugs is pretty farfetched. I think there should be multiple "stamps" of approval from a varie

The idea that we should all simply trust one entity to "approve" drugs is pretty farfetched. I think there should be multiple "stamps" of approval from a variety of entities that consumers can use to determine whether they want a particular drug... Why not have stamps from the FDA, insurer groups, physicians groups, etc.

criley2 9y ago
It's not farfetched in the least to have one entity approve the drugs based on roughly $1 billion dollars over 10 years[1] worth of research. What's more farfetched to me is allowing private, profit-motivated corporations the unfettered ability to produce this expensive research. Fortunately the all-but-oppressive regulation of the FDA from GLP and GMP to insanely rigorous science-based four phase system of testing is IMO the greatest achievement in science-based regulation in human history. People simple do not understand or respect the awesome power of the scientific method being the basis of government regulation. [1] http://onlinelibrary.wiley.com/doi/10.1002/9780470403587.ch1/summary http://onlinelibrary.wiley.com/doi/10.1002/9780470403587.ch1... or go to https://www.amazon.com/Drugs-Discovery-Approval-Rick-Ng/dp/047019510X https://www.amazon.com/Drugs-Discovery-Approval-Rick-Ng/dp/0... and use the "look inside" feature to see page 4: "It is estimated that, on average, a drug takes 10-12 years from initial research to reach the commercialization stage. The cost of this process is estimated to be over $1 billion USD" (2005) Another fun tidbit you'll find in the book: On average, for every 10,000 NME's that begin research, 1 NME will receive FDA approval. (where NME is a new molecular entity, a novel new drug). So you've got a market where you have to begin development on 10,000 products to get 1 product into the market, on a 10 year runway. Could you imagine that in tech? 9,999 pivots per product!
- orblivion 9y ago
  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
- DougWebb 9y ago
  An idea that I've had, for an approach to reduce the cost of drug development, would be to give the FDA the job and resources of carrying out the entire clinical trial process. They would be responsible for choosing which drugs to trial, running the trials, evaluating the results, and publishing the results. The pharmas would do the basic research, but they'd have to come up with a convincing argument that their new drug was worthwhile before the clinical trials could start. I'd hope that this would reduce costs because it eliminates all of the oversight that the FDA needs to do now to make sure the trials are being run properly, and that bad results aren't being hidden from view. It lets the FDA scientists control the whole process, and it would let the FDA short-circuit the process in cases where the scientists are satisfied by their counterparts in other countries approval of a drug. By giving adequate funding to the FDA, this approach would also allow the FDA to run trials on non-patentable drugs, nutrients, and remedies, which rarely happens today and could lead to much lower-cost treatments overall. The other big aspect of this idea is that the FDA publishes results. I'd have them publish a journal for medical professionals which includes notices of new drugs being considered for trials, the current trial schedule, reports on on-going trials, overviews of completed trials, and announcements for drugs that have been approved that includes usage guidelines for doctors. I'd also have them maintain a website targeted towards patients that includes handouts and detailed information for patients, similar to what's on Wikipedia, drugs.com, webmd, etc, but all centralized, searchable, and from a well-trusted official source. If the FDA takes care of all of that, then we can ban drug advertising. Doctors won't need it because they'd get the journal (which would be free), and patients don't need it because they'd have the website. So that eliminates a huge cost that the pharmas are incurring, and will no longer need to recover from sales. I don't know how feasible this is; I'm not an insider in the system. It would be a major shift in policy and a major budget increase for the FDA, so politically it'd be very difficult to accomplish. But if the end goal can work, then the political fight would be worth it.
maxerickson 9y ago
Insurance companies all evaluate drugs before putting them on their formulary and doctors do at least a little bit before they start writing a prescription. So there ya go.
- grandalf 9y ago
  Right, so why is the FDA the bottleneck to drugs coming to market? It makes no sense and creates a massive, overly risk-averse bureaucracy. There are tradeoffs involved for allowing a drug too soon, failing to take it off market fast enough in the face of new evidence, and for needlessly delaying time to market.

criley2 9y ago

It's not farfetched in the least to have one entity approve the drugs based on roughly $1 billion dollars over 10 years[1] worth of research. What's more farfetched to me is allowing private, profit-motivated corporations the unfettered ability to produce this expensive research. Fortunately the all-but-oppressive regulation of the FDA from GLP and GMP to insanely rigorous science-based four phase system of testing is IMO the greatest achievement in science-based regulation in human history. People simple do not understand or respect the awesome power of the scientific method being the basis of government regulation. [1] http://onlinelibrary.wiley.com/doi/10.1002/9780470403587.ch1/summary http://onlinelibrary.wiley.com/doi/10.1002/9780470403587.ch1... or go to https://www.amazon.com/Drugs-Discovery-Approval-Rick-Ng/dp/047019510X https://www.amazon.com/Drugs-Discovery-Approval-Rick-Ng/dp/0... and use the "look inside" feature to see page 4: "It is estimated that, on average, a drug takes 10-12 years from initial research to reach the commercialization stage. The cost of this process is estimated to be over $1 billion USD" (2005) Another fun tidbit you'll find in the book: On average, for every 10,000 NME's that begin research, 1 NME will receive FDA approval. (where NME is a new molecular entity, a novel new drug). So you've got a market where you have to begin development on 10,000 products to get 1 product into the market, on a 10 year runway. Could you imagine that in tech? 9,999 pivots per product!

orblivion 9y ago
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
DougWebb 9y ago
An idea that I've had, for an approach to reduce the cost of drug development, would be to give the FDA the job and resources of carrying out the entire clinical trial process. They would be responsible for choosing which drugs to trial, running the trials, evaluating the results, and publishing the results. The pharmas would do the basic research, but they'd have to come up with a convincing argument that their new drug was worthwhile before the clinical trials could start. I'd hope that this would reduce costs because it eliminates all of the oversight that the FDA needs to do now to make sure the trials are being run properly, and that bad results aren't being hidden from view. It lets the FDA scientists control the whole process, and it would let the FDA short-circuit the process in cases where the scientists are satisfied by their counterparts in other countries approval of a drug. By giving adequate funding to the FDA, this approach would also allow the FDA to run trials on non-patentable drugs, nutrients, and remedies, which rarely happens today and could lead to much lower-cost treatments overall. The other big aspect of this idea is that the FDA publishes results. I'd have them publish a journal for medical professionals which includes notices of new drugs being considered for trials, the current trial schedule, reports on on-going trials, overviews of completed trials, and announcements for drugs that have been approved that includes usage guidelines for doctors. I'd also have them maintain a website targeted towards patients that includes handouts and detailed information for patients, similar to what's on Wikipedia, drugs.com, webmd, etc, but all centralized, searchable, and from a well-trusted official source. If the FDA takes care of all of that, then we can ban drug advertising. Doctors won't need it because they'd get the journal (which would be free), and patients don't need it because they'd have the website. So that eliminates a huge cost that the pharmas are incurring, and will no longer need to recover from sales. I don't know how feasible this is; I'm not an insider in the system. It would be a major shift in policy and a major budget increase for the FDA, so politically it'd be very difficult to accomplish. But if the end goal can work, then the political fight would be worth it.

maxerickson 9y ago

Insurance companies all evaluate drugs before putting them on their formulary and doctors do at least a little bit before they start writing a prescription. So there ya go.

grandalf 9y ago
Right, so why is the FDA the bottleneck to drugs coming to market? It makes no sense and creates a massive, overly risk-averse bureaucracy. There are tradeoffs involved for allowing a drug too soon, failing to take it off market fast enough in the face of new evidence, and for needlessly delaying time to market.