7 ms·

I see two issues being conflated here. The first issue is the outrageous prices for generic drugs. The second issue is the true cost of research. Drug prices h

I see two issues being conflated here. The first issue is the outrageous prices for generic drugs. The second issue is the true cost of research. Drug prices have been rising out of control even for generic drugs (think epipens). It seems that competition is not driving down prices of generics. Perhaps it is time for government to break up "big parhma". Perhaps the FDA sets quality requirements so high that competitors cannot meet it, allowing that single manufacture to control prices. The other issue is the true cost of research. The production cost is a fraction of the true cost. Research is expensive. There would be no Remdesivir if we only paid production costs. As a biomedical researcher, I am always on the fence about jumping jobs for something that will pay better. Many investors and techies vastly underestimate the cost of scientific research BY ORDERS OF MAGNITUDE.

tomohawk 6y ago
Add to that the legal and regulatory costs. Getting a drug approved is very expensive and time consuming. The legal costs to defend the drug and its use in court after release can also be staggering. Most developed countries have the English Rule, which requires plaintiffs to pay the legal costs of defendants if they bring a suit and lose. The US does not.
javajosh 6y ago
I tend to agree that gov needs to step in, however the libtertarian in me also wants to know: why doesn't someone start a business selling this drug for, say, $200 instead of $540? If the answer to that is that the regulatory burden is basically insurmountable thanks to decades of regulatory capture, then yeah, government needs to act. Presumably such a company doesn't need to do any research, or get new approvals! They just need to make the thing and distribute it.
- deleted 6y ago
  [deleted]
- api 6y ago
  Here is an idea: anyone can make a generic drug if an independent FDA lab cannot tell the difference between unlabeled samples from the new manufacturer and unlabeled identically packaged samples from a currently approved manufacturer. You would need to do this testing continuously at random, so the FDA could just charge a fee for this. It would be way cheaper than full regulatory compliance.
  - pochamago 6y ago
    I like this idea, that seems like an elegant solution I haven't heard before.
  - mc32 6y ago
    “Anyone” ends up with cases where packaging operations are run right next to shipping, meaning all kinds of contamination can happen. Avoiding this situation means costly facilities with costly, inefficient but necessary regulation.
  - javajosh 6y ago
    Sounds good to me, but I don't think it would fly. It's too reactive. The FDA needs to be able to take proactive steps to avoid mistakes. So, I take your idea and raise you: Put cameras everywhere in your lab/factory, and give the FDA inspectors 24x7 access to every feed. This is in addition to allowing onsite random inspections, of course. I mean, as a consumer, this would make me feel warm and fuzzy about buying drugs from that company. I mean, you could even allow the public access to those feeds, as a marketing tool!
    - javajosh 6y ago
      You might even pay someone like the Vertitasium guy to do a walk through of how everything works, and then give the public access to your feeds.
  - deleted 6y ago
    [deleted]
  - pvaldes 6y ago
throwawaysea 6y ago
Research also isn’t priced at just its face value - there’s the opportunity cost of very smart and hard working people making it happen at overwhelming risk of failing. I think the main bloat is likely regulatory capture - we could start with the question “why can’t I make this drug in my garage” and work through each barrier. Equipment is part of it but the time and expense of navigating extensive regulations, building relationships with bureaucratic agencies, needing legal support, and so on prevents competition. Even if it isn’t as hard as it may seem to deal with all that, the reputation of it being an insurmountable barrier is enough to discourage would-be innovators.
- hellisothers 6y ago
  Thing is I don’t want life saving medicine from some guy who just started producing it in his garage last month. Fortunately I can afford the “regulated” dose myself if I had to. Most people can’t though and this is a role of govt, making sure everybody has access to a lifesaving drug _that the govt funded_. The solution isn’t “let poor people use bootleg garage drugs”, it’s the ensure lifesaving medication is priced affordably. This is one of those situations where capitalism by itself isn’t well configured to deal with. This and, say, emergency room visits...
  - Red_Leaves_Flyy 6y ago
    Since we can't figure out how to treat diseases in poor patients as they start we all pay a whole Hell of a lot more when they land in the er.
downvoteme1 6y ago
I think that in the case of epipen, the patent is on the drug delivery mechanism - the pen, rather than the epi. There are other competitive products out there but they cannot deliver the drug as efficiently or accurately as the epipen.
ykevinator 6y ago
But all research relies on massive banks of publicly funded research so the cost of research was already paid for by tax payers.
nabaraz 6y ago
Except: 1) Taxpayers paid $70.5 million 2) Remdesivir was discovered through a collaboration between Gilead and US Army. 3) Remdesivir received funding from DOD and CDC (for Ebola treatment)
- sdinsn 6y ago
  Note that the government giving companies money doesn't mean the government magically owns any rights to the medication.
  - atomi 6y ago
    Perhaps that's something the taxpayers should demand?
    - sdinsn 6y ago
      "The taxpayers"? I'm a tax payer, and I want no such thing. Speak only for yourself please.
      - Red_Leaves_Flyy 6y ago
        I'm another taxpayer. I support the the commenter above you.
      - mam2 6y ago
        Why not ?
        gtt 6y ago
        Well, some countries before tried to have a collective ownership of productive assets and it hasn't really worked out: it misaligns incentives all the way down.
        atomi 6y ago
        This is an extremely vague retort. Are you proposing the government should have no attached requirements to qualify for subsidies? Are you flatly against all regulation when a particular company is given tax money? For what it's worth, the government can regulate any industry regardless of whether it is subsidized.

tomohawk 6y ago

Add to that the legal and regulatory costs. Getting a drug approved is very expensive and time consuming. The legal costs to defend the drug and its use in court after release can also be staggering. Most developed countries have the English Rule, which requires plaintiffs to pay the legal costs of defendants if they bring a suit and lose. The US does not.

javajosh 6y ago

I tend to agree that gov needs to step in, however the libtertarian in me also wants to know: why doesn't someone start a business selling this drug for, say, $200 instead of $540? If the answer to that is that the regulatory burden is basically insurmountable thanks to decades of regulatory capture, then yeah, government needs to act. Presumably such a company doesn't need to do any research, or get new approvals! They just need to make the thing and distribute it.

deleted 6y ago
[deleted]
api 6y ago
Here is an idea: anyone can make a generic drug if an independent FDA lab cannot tell the difference between unlabeled samples from the new manufacturer and unlabeled identically packaged samples from a currently approved manufacturer. You would need to do this testing continuously at random, so the FDA could just charge a fee for this. It would be way cheaper than full regulatory compliance.
- pochamago 6y ago
  I like this idea, that seems like an elegant solution I haven't heard before.
- mc32 6y ago
  “Anyone” ends up with cases where packaging operations are run right next to shipping, meaning all kinds of contamination can happen. Avoiding this situation means costly facilities with costly, inefficient but necessary regulation.
- javajosh 6y ago
  Sounds good to me, but I don't think it would fly. It's too reactive. The FDA needs to be able to take proactive steps to avoid mistakes. So, I take your idea and raise you: Put cameras everywhere in your lab/factory, and give the FDA inspectors 24x7 access to every feed. This is in addition to allowing onsite random inspections, of course. I mean, as a consumer, this would make me feel warm and fuzzy about buying drugs from that company. I mean, you could even allow the public access to those feeds, as a marketing tool!
  - javajosh 6y ago
    You might even pay someone like the Vertitasium guy to do a walk through of how everything works, and then give the public access to your feeds.
- deleted 6y ago
  [deleted]
- pvaldes 6y ago

throwawaysea 6y ago

Research also isn’t priced at just its face value - there’s the opportunity cost of very smart and hard working people making it happen at overwhelming risk of failing. I think the main bloat is likely regulatory capture - we could start with the question “why can’t I make this drug in my garage” and work through each barrier. Equipment is part of it but the time and expense of navigating extensive regulations, building relationships with bureaucratic agencies, needing legal support, and so on prevents competition. Even if it isn’t as hard as it may seem to deal with all that, the reputation of it being an insurmountable barrier is enough to discourage would-be innovators.

hellisothers 6y ago
Thing is I don’t want life saving medicine from some guy who just started producing it in his garage last month. Fortunately I can afford the “regulated” dose myself if I had to. Most people can’t though and this is a role of govt, making sure everybody has access to a lifesaving drug _that the govt funded_. The solution isn’t “let poor people use bootleg garage drugs”, it’s the ensure lifesaving medication is priced affordably. This is one of those situations where capitalism by itself isn’t well configured to deal with. This and, say, emergency room visits...
- Red_Leaves_Flyy 6y ago
  Since we can't figure out how to treat diseases in poor patients as they start we all pay a whole Hell of a lot more when they land in the er.

downvoteme1 6y ago

I think that in the case of epipen, the patent is on the drug delivery mechanism - the pen, rather than the epi. There are other competitive products out there but they cannot deliver the drug as efficiently or accurately as the epipen.

ykevinator 6y ago

But all research relies on massive banks of publicly funded research so the cost of research was already paid for by tax payers.

nabaraz 6y ago

Except: 1) Taxpayers paid $70.5 million 2) Remdesivir was discovered through a collaboration between Gilead and US Army. 3) Remdesivir received funding from DOD and CDC (for Ebola treatment)

sdinsn 6y ago
Note that the government giving companies money doesn't mean the government magically owns any rights to the medication.
- atomi 6y ago
  Perhaps that's something the taxpayers should demand?
  - sdinsn 6y ago
    "The taxpayers"? I'm a tax payer, and I want no such thing. Speak only for yourself please.
    - Red_Leaves_Flyy 6y ago
      I'm another taxpayer. I support the the commenter above you.
    - mam2 6y ago
      Why not ?
      - gtt 6y ago
        Well, some countries before tried to have a collective ownership of productive assets and it hasn't really worked out: it misaligns incentives all the way down.
        atomi 6y ago
        This is an extremely vague retort. Are you proposing the government should have no attached requirements to qualify for subsidies? Are you flatly against all regulation when a particular company is given tax money? For what it's worth, the government can regulate any industry regardless of whether it is subsidized.