Yes, there are a lot of heavy, potentially onerous requirements to releasing a drug. Sometimes these requirements result in drugs taking a long time to be publicly available. But the goal of this process is public safety, not making a quick buck.
Yes, there are a lot of heavy, potentially onerous requirements to releasing a drug. Sometimes these requirements result in drugs taking a long time to be publicly available. But the goal of this process is public safety, not making a quick buck.
This means that they are incentivized to be cautious, sometimes excessively so.
How do you prove a new product from a hostile industry safe, without having regulations covering the types of tests and acceptable reporting necessary?
There is certainly evidence that since regulatory bodies get tons of flack for letting through bad drugs, but aren't imposed on that much for slowing down the process, they incline to being risk adverse. We also have evidence of outcomes in Europe where the regulatory regimes differ and seem to approve things faster with outcomes that aren't generally worse than the US.
I highly doubt we have the optimal regulatory solution at present and could do much better. And if anything we have standards that are too high.
The current solution seems to be to increase the barrier until the bad actors are gone; as this means there is less finger pointing.
Going the other way would seem to take active effort from a political representative, and the outcome will end in deaths directly attributable to them.... which would be career suicide.
Many countries with cheap drugs never had to pay all of the research and development costs.
If it's not government greed, it's government ineptness and the inability to understand how the market actually works.
The generic company in this article, for instance, never had to pay any R&D costs for the proprietary epipen applicator and can easily charge a much lower amount of money for a generic version (which is different).
The high cost of FDA approval also creates monopolies, because it's very difficult to get anything to market. To get better and cheaper drugs, we need to change this at the government level.