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We've "regulated [it] away" in the sense that drugs that only pull in $1m a year aren't considered economically viable. I'm not sure regulation is the appropria

We've "regulated [it] away" in the sense that drugs that only pull in $1m a year aren't considered economically viable. I'm not sure regulation is the appropriate villian in this case. FTA: >new antibiotics typically end up with list prices in the $2,000 — $3,000 range (for a one-time cure!) while payers gladly shell out tens or hundreds of thousands for cancer drugs or medicines for rare genetic diseases. Low sales volumes (due to stewardship) and low price points (due to DRG-driven pricing pressures) result in minimal sales for novel antibiotics. Achaogen’s new antibiotic was seeing unimpressive sales of around a million dollars per quarter before the company folded. At these sales figures, the company would have never recouped the cost of developing the drug. Of course, we don't want antibiotics to cost $10k a unit, much less $100k. Thus my question about the implicit assumption that the same development pipeline that's working on $100k+ cancer drugs is suitable for antibiotic development.

JamesBarney 7y ago
The current regulations are setup so that it costs a mountain of money to make an antibiotic and you can only make a molehill of money. That seems like regulating the R&D away. Of course what you want is antibiotics to cost a dollar and be as safe as apply pie and as plentiful as salt water. But that's not really an options. Our options are the status quo, heavily subsidize antibiotic research and pricing, reduce regulations so they can be developed incredibly cheaply, or change regulations to drive up sales.
- magduf 7y ago
  >The current regulations are setup so that it costs a mountain of money to make an antibiotic and you can only make a molehill of money. That seems like regulating the R&D away. So why can't pharma companies move their operations to countries with fewer regulations?
  - JamesBarney 7y ago
    If you get drug approved in Uganda the FDA won't let you sell it here. You still need to pass FDA phase 1 2 and 3 trials.
    - magduf 7y ago
      Well if you're making a drug to immunize against Ebola, you don't really need it to be FDA approved, since most of the Ebola is in Africa. Getting it approved in Uganda is sufficient. Then, if it comes across the Atlantic and starts killing Americans left and right, while Africans are immunized because their approval process was easier, it would be interesting to see what the FDA does.
ufmace 7y ago
The reason why $1m/yr isn't enough isn't because the pharma companies are just too greedy. It's because conducting the clinical trial required to get them through regulation is so massively expensive that they can't make anything at all at those revenue levels. Maybe it's time we back up and rethink what we really want here. It seems like the root cause is the highly risk-adverse regulation environment. The Government could take a bigger role in drug/vaccine development, but it seems unlikely that getting the Government more involved will result in a faster-moving and less risk-adverse development system that can rapidly apply sufficient resources to address a sudden threat, and then follow through with the development even after the immediate threat has already abated. It seems like the solution is to make the regulatory/approval environment less strict and expensive instead. That will allow anyone who develops drugs, whether large or small private companies or Government agencies, to get them to the public more rapidly.

JamesBarney 7y ago

The current regulations are setup so that it costs a mountain of money to make an antibiotic and you can only make a molehill of money. That seems like regulating the R&D away. Of course what you want is antibiotics to cost a dollar and be as safe as apply pie and as plentiful as salt water. But that's not really an options. Our options are the status quo, heavily subsidize antibiotic research and pricing, reduce regulations so they can be developed incredibly cheaply, or change regulations to drive up sales.

magduf 7y ago
>The current regulations are setup so that it costs a mountain of money to make an antibiotic and you can only make a molehill of money. That seems like regulating the R&D away. So why can't pharma companies move their operations to countries with fewer regulations?
- JamesBarney 7y ago
  If you get drug approved in Uganda the FDA won't let you sell it here. You still need to pass FDA phase 1 2 and 3 trials.
  - magduf 7y ago
    Well if you're making a drug to immunize against Ebola, you don't really need it to be FDA approved, since most of the Ebola is in Africa. Getting it approved in Uganda is sufficient. Then, if it comes across the Atlantic and starts killing Americans left and right, while Africans are immunized because their approval process was easier, it would be interesting to see what the FDA does.

ufmace 7y ago

The reason why $1m/yr isn't enough isn't because the pharma companies are just too greedy. It's because conducting the clinical trial required to get them through regulation is so massively expensive that they can't make anything at all at those revenue levels. Maybe it's time we back up and rethink what we really want here. It seems like the root cause is the highly risk-adverse regulation environment. The Government could take a bigger role in drug/vaccine development, but it seems unlikely that getting the Government more involved will result in a faster-moving and less risk-adverse development system that can rapidly apply sufficient resources to address a sudden threat, and then follow through with the development even after the immediate threat has already abated. It seems like the solution is to make the regulatory/approval environment less strict and expensive instead. That will allow anyone who develops drugs, whether large or small private companies or Government agencies, to get them to the public more rapidly.