"Demand" is not a good metric for proper medical or safety review. There is constant demand for products that promise amazing things, but they should not be approved more rapidly because of their claims until they have gone through the proper process and reviews to show both that they do what they claim and that they do not have other serious side effects or consequences.
We're talking about allowing an "essentially" generic version of an existing FDA approved drug made by licensed compounding pharmacies that has been legally distributed for years due to the shortage. If it's safe enough for people to take in a shortage then it's probably safe enough for people to take in a not shortage.
You’re putting more things I. The FDA’s regulatory basket than the law intends.
Whether or not “people who could benefit have access” is not relevant to the FDA’s mandate. The intent of the FDA is to regulate the safety and efficacy of medicines - not access, not price.
Once supply was addressed, the FDA’s regulatory objectives were complete
I don’t understand how it’s not legally required to be covered by all insurance in the US given all the health problems downstream of being overweight.
Because then the companies that have been given legal license to monopolize this technology (through the legal technology known as "patents") could charge whatever price they wanted and insurance companies would have to pay for it? The ability for an insurance company to say no is literally their only negotiation leverage.
Every country arranges their payment mechanism slightly differently- the US is worse than pretty much all of them but they are all slightly different- but every form of insurance has to be able to walk away in the negotiations, or else the monopoly producer will hike the price up.
I imagine if you forced insurance to cover but also removed patent protection and allowed generics immediately... drug companies would be even more unhappy than the insurance companies would if you forced them to cover GLP-1's.
Well, 67% of Americans are overweight and the mandatory drug costs $1k. So premiums must be $670 per person or higher to cover nothing but this drug. The drug manufacturers will know that the insurers must provide it so they’ll use the highest price they used at scale: $1k.
That means that every healthy person is also paying $670 per month just so that the 2/3 of the country can get this drug. But current medical loss ratios are at least 85% and if we did nothing but pay $670 we’d be at 100% loss ratio and the drug paid for.
Boy the economics for the average person look pretty bad, considering they can just get it off the internet for a fraction. I have 240 mg of retatrutide in my fridge for about a dollar a mg in comparison.
It would have to be mandated across the board. Problem with insurance in the US is that it is tied to employment and therefore temporary. The majority of least problems downstream from obesity will be felt by some future insurance company, very likely not your current one.
If I were Trump for a day I'd force Lilly to sell the tirzepatide patent to the federal government (I'd even pay them a fair amount) and then make it a generic. Maybe a subsidized generic, even. Then in a decade or so the citizenry might actually be okay naming things after me. Though it might require dialing back some other activities, but whatever.
Arainach|22 days ago
Spivak|22 days ago
refurb|22 days ago
Whether or not “people who could benefit have access” is not relevant to the FDA’s mandate. The intent of the FDA is to regulate the safety and efficacy of medicines - not access, not price.
Once supply was addressed, the FDA’s regulatory objectives were complete
lotsofpulp|22 days ago
mandevil|22 days ago
Every country arranges their payment mechanism slightly differently- the US is worse than pretty much all of them but they are all slightly different- but every form of insurance has to be able to walk away in the negotiations, or else the monopoly producer will hike the price up.
I imagine if you forced insurance to cover but also removed patent protection and allowed generics immediately... drug companies would be even more unhappy than the insurance companies would if you forced them to cover GLP-1's.
renewiltord|22 days ago
That means that every healthy person is also paying $670 per month just so that the 2/3 of the country can get this drug. But current medical loss ratios are at least 85% and if we did nothing but pay $670 we’d be at 100% loss ratio and the drug paid for.
Boy the economics for the average person look pretty bad, considering they can just get it off the internet for a fraction. I have 240 mg of retatrutide in my fridge for about a dollar a mg in comparison.
Someone1234|22 days ago
PS - And, yes, compound versions are $100/month, but insurance doesn't cover those.
refurb|22 days ago
Insurance companies are allowed to limit access to more expensive therapies unless cheaper therapies have been tried and have failed.
rootusrootus|22 days ago
If I were Trump for a day I'd force Lilly to sell the tirzepatide patent to the federal government (I'd even pay them a fair amount) and then make it a generic. Maybe a subsidized generic, even. Then in a decade or so the citizenry might actually be okay naming things after me. Though it might require dialing back some other activities, but whatever.
koolba|22 days ago
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