> The FDA is partially to blame for this situation: ...

> The cost of performing a New Drug Application starts in the mid hundreds of millions of dollars range and can extend into the billions for some drugs.

> So nobody could feasibly introduce it to the market here without investing $500 million or more up front. At that price, your only viable option is to stick a big price tag on it and try to milk that money back from insurers.

It's interesting that you seem so passionate about this because you're totally incorrect. The cost of a NDA for a novel prescription drug requiring clinical data (the most expensive application) is ~$4.5mil. In fact, the estimated TOTAL revenue to the FDA from ALL PD application fees in FY 2025 is ~$1.3billion (or, just under 300 novel prescription drugs). So, obviously, FDA fees can't be as much as you're claiming.

What you're actually describing is the total cost of the entire drug development pipeline (research, design, lab costs, chemical costs, application costs, marketing costs, etc.) to develop a brand new, novel drug. And it's only ~$200m, increasing to $500m if you include dead ends / failures in the process, and ~$900m if you include both failures and capital costs--yep, that's right the capital costs alone are almost as much as the entire rest of the drug development pipeline.

See: https://jamanetwork.com/journals/jamanetworkopen/fullarticle...

And that's for novel Prescription Drugs.

> They required a complete New Drug Application before they would let anyone bring it to market, even though it's over the counter in other countries.

No. In that case they would pay the FDA OMUFA fees, not the FDA PDUFA fees, which are ten to fifty times cheaper than the PDUFA fees.