> I suppose only things that definitely cause harm, because otherwise why not just ask for the same deal that Biogen got, and go out and prove efficacy while you turn a profit?

In a sense, this is how it's sort of always worked. The approval process is about protecting investors. If a drug is good it's usually pretty obvious. When it's not obvious, efficacy in a more abstract sense must account for cost, which is out of the FDA's jurisdiction.

The real problem with its organization is that it is, as you're saying, Medicare's procurement agent. But it is not empowered to consider cost.

The FDA only judges the medical evidence. That is complex enough.

Adding pricing to it's concerns would make what is already a nightmare process even worse.

> Adding pricing to its concerns would make what is already a nightmare process even worse.

TBH, I believe that is a huge root cause problem with our health care system. We need to stop pretending that money is infinite, and measure the cost against the benefit (in this case, little or none) when deciding whether Medicare/insurance companies should pay for a treatment.

Perhaps this shouldn't be the responsibility of the FDA, but SOMEWHERE there should exist a process that says, "OK, this drug increases lifespan on average by 1 week, but costs $10,000 a month in treatment, sorry we're not going to cover it."

This is how it works in the U.K.

The MHRA decides which drugs are safe and effective and for which diagnoses.

Then NICE decides which of those drugs are available on the public health system (NHS) by evaluating £/quality-adjusted life year. I don’t see why Medicare should be any different.

If it’s not available on the public health system you can still pay for it yourself or via private insurance provided it’s licensed by the MHRA.

Only a few short years ago, the eminently sensible idea of offering end of life planning (making a will, recording end of life medical desires) was demonized/weaponized as “death panels”.

What you’re saying seems sensible, but my cynicism…

Not for nothing, but, despite all the airtime this issue gets, my understanding is that pharmaceuticals are a pretty small component of health care spending; like, if you zeroed it out, you'd get less than a grocery store discount.

Data for 2019 [0]:

> NHE grew 4.6% to $3.8 trillion in 2019, or $11,582 per person, and accounted for 17.7% of Gross Domestic Product (GDP).

> Prescription drug spending increased 5.7% to $369.7 billion in 2019, faster than the 3.8% growth in 2018.

So that is around 10%. Still a pretty high amount of money.

[0] https://www.cms.gov/Research-Statistics-Data-and-Systems/Sta...

I disagree. See https://www.politifact.com/factchecks/2019/feb/22/amy-klobuc... (drug costs come between 15-17% of total spending). And given how you can divvy up spending (drugs, facilities, doctors, nurses, admin staff, overhead, etc.), one sixth of total spending seems like a very large amount.

And, it's especially the case that for certain individuals (this page also made the top of HN today, https://www.goodrx.com/blog/most-expensive-drugs-period/) that drug costs are a gargantuan, total-lifetime-salary kind of expenditure.

Look up QALY, quality-adjusted life-year. US insurance companies take it into consideration.

What if all drug prices were set based on efficacy, and drug manufacturers had no say in pricing?

Considering their own advisory committee advised against approving the drug because of the lack of evidence that it works, the FDA doesn't really judge the medical evidence very well!