The strict FDA requirements are there to make sure only safe and effective products come onto the market. That's a good thing. What's bad is that some can use this system to their advantage to create artificial monopolies.
If you're the only maker of a drug, and even if it's not covered by any patents, you know it'll still take months or perhaps years for a competitor to get FDA approval and compete with you. You can jack up your prices until competitors go through the approval, and you can signal to the market that you will quickly drop the prices if another competitor comes onto the market. This discourages the competitors from even spending the time and money on FDA approval.
Two possible solution to this: (1) reduce the cost of FDA approval for companies that want to make generic copies; or (2) impose taxes or price caps on FDA products that have no competition and command market power.
This all assumes patents are not involved (as is the case here), but both solutions would reduce the intensive for companies to game a system that is intended to make sure only safe products make it onto the market.
It's about the drug delivery device (i.e. the "pen"), and the failure of Pfizer/Meridian (the contract manufacturer of the device) to follow correct design and manufacturing practices.
They don't have a proper CAPA system in place, they don't have proper design control or procedures, the DHFs are missing up to date inputs, risk analysis isn't up to date, etc.
It's pretty damning, but it's not about the pharma aspect of this. Basically the manufacturer lacks a functional quality system, which is table stakes for this stuff.
I would guess because once approved, the FDA has a much more limited role. I believe they can force a recall though. Technically the problem was mechanical, not pharmaceutical. I'm not sure if that had anything to do with it though.
If you're the only maker of a drug, and even if it's not covered by any patents, you know it'll still take months or perhaps years for a competitor to get FDA approval and compete with you. You can jack up your prices until competitors go through the approval, and you can signal to the market that you will quickly drop the prices if another competitor comes onto the market. This discourages the competitors from even spending the time and money on FDA approval.
Two possible solution to this: (1) reduce the cost of FDA approval for companies that want to make generic copies; or (2) impose taxes or price caps on FDA products that have no competition and command market power.
This all assumes patents are not involved (as is the case here), but both solutions would reduce the intensive for companies to game a system that is intended to make sure only safe products make it onto the market.