6 ms·

> In principle I am opposed to regulation, but in this case, where all other measures have failed, I say regulate away. But the article says there would be com

by b6 10y ago

> In principle I am opposed to regulation, but in this case, where all other measures have failed, I say regulate away. But the article says there would be competition except that it's too hard to get a product to market. Doesn't the author mean it's too hard to compete because of regulation, like from the FDA?

endswapper 10y ago
Pardon if this point wasn't clear. I am talking about additional, direct regulation related to this product and this issue. Normally, I would say the logic doesn't follow that, the answer to failed regulation is more regulation. However, in this case, my opinion is that we should call this out for what it is and do something to counteract it.
- phil21 10y ago
  This is a ridiculous stance to take. So because one drug/company decided to raise prices 1500% we need to take immediate and specific action. But those companies who operate at 600% markup in the same industry are perfectly fine. I can guarantee you the latter are where the actual problem lies - since it's systemic. The outliers that get press are good - but only if people solve the problem vs. kneejerk reactions like specific legislation for a single drug. My point is that every drug company is doing this. And not a little bit. We shouldn't set some ridiculous threshold before we take action (as long as we're stolen from, it's ok if it's only a small amount right?) - we should fix the problem where it begins. This means adding competition to the market, in which case the usual race to the bottom should occur. You are basically advocating for a tiny measure that "fixes" a fraction of a fraction of a percentage of wasteful drug spending - and simply focusing on manufactured outrage. This is how the industry continues to win.
  - endswapper 10y ago
    It's not ridiculous at all. If we are talking about one company then specific action seems appropriate. I agree that there are systemic issues. I think that is a larger conversation that will take more time. There are merits to the European systems that are generally more liberal, or at least are characterized as such, and likewise, merits to the US system. We could probably cherry pick examples in each system and perhaps that is how it will continue in that larger conversation. However, in this instance, which is the context I am focused on we recognize that allowing a monopoly is a failure. It presents special circumstances, so special action to sidestep the bureaucracy seems appropriate to me. I believe that the proverbial 2x4 to the head (of Mylan, in this instance), would do more to further the larger conversation and the points we agree on, than waiting for the conversation to conclude with a pretty bow. It won't. Making examples of the most egregious perpetrators has an immediate, albeit incremental impact.
    - phil21 10y ago
      I guess we'll have to agree to disagree. I see negative value in stamping down the outliers. This just sweeps the conversation under the rug and people feel good about "doing something". We then all can rage against the latest scapegoat who is doing exactly what everyone else in their position is - they just got a bit too aggressive and got unlucky on the roll of the PR dice. The rest of the industry laughs and continues to reap 900% margin on generic products, and increases it 15% next year since 15% is totally reasonable. We then repeat the next two minutes of hate every 2-3 years. We are talking about a price increase from a floor that was already absolutely insane. $300 for a $20 or less to manufacturer device is already being ripped off, and we are only just now talking about it because it went to $600. Why is there a difference in reactions here? Are you the one who gets to judge a $580 profit is ok vs. a $280 profit? Why? They both seem obscene to me - why is this just now becoming a problem? Obviously $300 is an acceptable price - so is $400? $500? This is just the tip of the iceberg. If you start by clipping the tall poppies you might get some extremely slight downward pressure on prices in the market - but that does nothing to solve your actual problems. It's penny wise and pound foolish and is the approach we've thus far taken with predictable results.
      - endswapper 10y ago
        I think that, generally, in principle, we agree. Where we disagree is in practice. Doing nothing, or a little empty outrage is sweeping it under the rug, or "the approach thus far." What I am talking about has a practical benefit beyond targeting the worst offenders, which again seems appropriate. Establishing a precedent for what is "too aggressive" frames the conversation going forward. Otherwise, your logic, "Obviously $300 is an acceptable price - so is $400? $500?," is valid. When human lives are at stake I don't think it is. So, establishing a precedent and thereby the beginning of a framework we move the conversation forward rather than just another lap on the rotary. I also disagree that doing something is the same as doing nothing. I find that practically and logically false. Particularly, in the context of progress in a bureaucracy, it has been the modest incremental changes that have created the opening for larger reform.
        10y ago
jschwartzi 10y ago
Generally, yes. The FDA can block anything for any reason, including usability or safety concerns. The easiest process to move thorough is the 510k, but you can only do that if there are consensus-based standards or existing devices you can use as a predicate. Otherwise your product could be held up by the FDA for years or decades, with no clear path to release. It seems like cloning the Epipen could be a simple process, but you still have to show substantial equivalence and do a bunch of validation to ensure the product is safe and effective. I'm not an expert in this, by any means. All my knowledge comes from working in an FDA-regulated industry.

by b6 10y ago

endswapper 10y ago

Pardon if this point wasn't clear. I am talking about additional, direct regulation related to this product and this issue. Normally, I would say the logic doesn't follow that, the answer to failed regulation is more regulation. However, in this case, my opinion is that we should call this out for what it is and do something to counteract it.

phil21 10y ago
This is a ridiculous stance to take. So because one drug/company decided to raise prices 1500% we need to take immediate and specific action. But those companies who operate at 600% markup in the same industry are perfectly fine. I can guarantee you the latter are where the actual problem lies - since it's systemic. The outliers that get press are good - but only if people solve the problem vs. kneejerk reactions like specific legislation for a single drug. My point is that every drug company is doing this. And not a little bit. We shouldn't set some ridiculous threshold before we take action (as long as we're stolen from, it's ok if it's only a small amount right?) - we should fix the problem where it begins. This means adding competition to the market, in which case the usual race to the bottom should occur. You are basically advocating for a tiny measure that "fixes" a fraction of a fraction of a percentage of wasteful drug spending - and simply focusing on manufactured outrage. This is how the industry continues to win.
- endswapper 10y ago
  It's not ridiculous at all. If we are talking about one company then specific action seems appropriate. I agree that there are systemic issues. I think that is a larger conversation that will take more time. There are merits to the European systems that are generally more liberal, or at least are characterized as such, and likewise, merits to the US system. We could probably cherry pick examples in each system and perhaps that is how it will continue in that larger conversation. However, in this instance, which is the context I am focused on we recognize that allowing a monopoly is a failure. It presents special circumstances, so special action to sidestep the bureaucracy seems appropriate to me. I believe that the proverbial 2x4 to the head (of Mylan, in this instance), would do more to further the larger conversation and the points we agree on, than waiting for the conversation to conclude with a pretty bow. It won't. Making examples of the most egregious perpetrators has an immediate, albeit incremental impact.
  - phil21 10y ago
    I guess we'll have to agree to disagree. I see negative value in stamping down the outliers. This just sweeps the conversation under the rug and people feel good about "doing something". We then all can rage against the latest scapegoat who is doing exactly what everyone else in their position is - they just got a bit too aggressive and got unlucky on the roll of the PR dice. The rest of the industry laughs and continues to reap 900% margin on generic products, and increases it 15% next year since 15% is totally reasonable. We then repeat the next two minutes of hate every 2-3 years. We are talking about a price increase from a floor that was already absolutely insane. $300 for a $20 or less to manufacturer device is already being ripped off, and we are only just now talking about it because it went to $600. Why is there a difference in reactions here? Are you the one who gets to judge a $580 profit is ok vs. a $280 profit? Why? They both seem obscene to me - why is this just now becoming a problem? Obviously $300 is an acceptable price - so is $400? $500? This is just the tip of the iceberg. If you start by clipping the tall poppies you might get some extremely slight downward pressure on prices in the market - but that does nothing to solve your actual problems. It's penny wise and pound foolish and is the approach we've thus far taken with predictable results.
    - endswapper 10y ago
      I think that, generally, in principle, we agree. Where we disagree is in practice. Doing nothing, or a little empty outrage is sweeping it under the rug, or "the approach thus far." What I am talking about has a practical benefit beyond targeting the worst offenders, which again seems appropriate. Establishing a precedent for what is "too aggressive" frames the conversation going forward. Otherwise, your logic, "Obviously $300 is an acceptable price - so is $400? $500?," is valid. When human lives are at stake I don't think it is. So, establishing a precedent and thereby the beginning of a framework we move the conversation forward rather than just another lap on the rotary. I also disagree that doing something is the same as doing nothing. I find that practically and logically false. Particularly, in the context of progress in a bureaucracy, it has been the modest incremental changes that have created the opening for larger reform.
      - 10y ago

jschwartzi 10y ago

Generally, yes. The FDA can block anything for any reason, including usability or safety concerns. The easiest process to move thorough is the 510k, but you can only do that if there are consensus-based standards or existing devices you can use as a predicate. Otherwise your product could be held up by the FDA for years or decades, with no clear path to release. It seems like cloning the Epipen could be a simple process, but you still have to show substantial equivalence and do a bunch of validation to ensure the product is safe and effective. I'm not an expert in this, by any means. All my knowledge comes from working in an FDA-regulated industry.