Does the cost to get a drug approved depend on how novel or irreplaceable it might be? Did it cost the same amount to approve Silenor for insomnia as it would cost to approve a really novel drug much better at combating insomnia than any existing one?
If the FDA imposes equal costs on any new drug, then it’s not “imposing [costs] on a company trying to [...] parasitize the healthcare system”. It’s neutrally imposing costs on all companies developing drugs. And this probably does a lot more harm on net (fewer drugs marketed) then it does good (punishes some drugs that harm society).
Silenor may be a bad example for the anti-FDA narrative, but I don’t think this is strong evidence against the narrative, given all the other (hopefully good) examples that we have.
To be clear, it’s very important and beneficial to call out bad examples in a narrative, thank you for doing that. We should update on this information. But I don’t agree with your conclusions.
Pharma companies can probably estimate the cost of bringing a new drug to market, and make a rational cost-benefit decision (citation needed). Somaxon presumably made a bad decision with Silenor, and was ‘punished’ by losing money.
That’s what happens to any companies in a market. Even if it was cheap to bring a drug to market, companies would still make money on some drugs but lose money on others. Why do we need an agency like the FDA imposing extra costs?
One of the complaints about the FDA is that only big and well-established companies can afford to bring a drug to market. It’s a moat against new competitors, and a net harm to society because fewer good drugs are developed and approved.
Suppose the FDA found a way to make drug approval cost 50% less, while still approving the same drugs in the same amount of time. That is, pharma companies would pay half what they do now to go through the process. Most people would say this is a good thing, i.e. less dead loss. Would you call it a bad thing because it would reduce the ‘punishment’ of companies? If so, do you think the cost should be increased, or does it happen to be just right?
Did it cost the same amount to approve Silenor for insomnia as it would cost to approve a really novel drug much better at combating insomnia than any existing one?
The FDA wants proof that drugs have a statistical significant effect. The stronger the effect of your drug happens to be the less people you need in your phase III trials.
Does the cost to get a drug approved depend on how novel or irreplaceable it might be? Did it cost the same amount to approve Silenor for insomnia as it would cost to approve a really novel drug much better at combating insomnia than any existing one?
If the FDA imposes equal costs on any new drug, then it’s not “imposing [costs] on a company trying to [...] parasitize the healthcare system”. It’s neutrally imposing costs on all companies developing drugs. And this probably does a lot more harm on net (fewer drugs marketed) then it does good (punishes some drugs that harm society).
Silenor may be a bad example for the anti-FDA narrative, but I don’t think this is strong evidence against the narrative, given all the other (hopefully good) examples that we have.
To be clear, it’s very important and beneficial to call out bad examples in a narrative, thank you for doing that. We should update on this information. But I don’t agree with your conclusions.
Pharma companies can probably estimate the cost of bringing a new drug to market, and make a rational cost-benefit decision (citation needed). Somaxon presumably made a bad decision with Silenor, and was ‘punished’ by losing money.
That’s what happens to any companies in a market. Even if it was cheap to bring a drug to market, companies would still make money on some drugs but lose money on others. Why do we need an agency like the FDA imposing extra costs?
One of the complaints about the FDA is that only big and well-established companies can afford to bring a drug to market. It’s a moat against new competitors, and a net harm to society because fewer good drugs are developed and approved.
Suppose the FDA found a way to make drug approval cost 50% less, while still approving the same drugs in the same amount of time. That is, pharma companies would pay half what they do now to go through the process. Most people would say this is a good thing, i.e. less dead loss. Would you call it a bad thing because it would reduce the ‘punishment’ of companies? If so, do you think the cost should be increased, or does it happen to be just right?
The FDA wants proof that drugs have a statistical significant effect. The stronger the effect of your drug happens to be the less people you need in your phase III trials.