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Comment by gamepsys | Hacker News Reader

I like this trend of the FDA making more and more things OTC.

I don't get why things like CGMs require a prescription. It's just a kind of a wearable sensor. While typically only a diabetic person would need it, I fail to see any harm for any adult human if they get curious and want to stick one.

There are odd things like glasses or CPAP machine prescriptions - but at least I understand it's theoretically possible to cause some harm to oneself with those, if someone is really uneducated, reckless or stupid. With a CGM I just can't think of a sensible scenario. Except for the really stupid ones, but then a simple kitchen fork is a four times worse hazard.

Don't be fooled by the reason though

> The markup on OTC products is generally higher than on prescription medications.

https://www.eposnow.com/us/resources/how-do-pharmacies-make-....

For medical products though, it seems great. OTC hearing aids are a big win for society.

I have an extremely hard time buying into the idea that that the reason for making glucose monitors available over the counter is simply to increase the profit margins of drug stores.

I haven't noticed this as a consumer in the context we're talking right now. I think that article is measuring the difference between OTC and pharmacy pricing after a drug is approved OTC. But it is not looking at prices pre- vs. post- OTC approval.

Olopatadine eye drops are amazing for allergy season, and they used to be like $250-400/bottle just 5 years ago or so, even the generic version. Then they went OTC for like $10/bottle.

This pricing difference might be true for things that are already mostly cheap, like Omeprazole -- where branding on consumer products drives OTC markup, but consumers don't pick the brand when doctors prescribe it and the pharmacy just gives them whatever cheapest generic they have in the back that they negotiated excellent pricing on.

Though you can easily close the gap on these prices by shopping for the store-brand generics at Costco, Walmart, Sam's Club, etc.

It turns out when you strip out as much of the billing bureaucracy as possible, that things become cheaper.

I think "captive market" probably contributes more than "billing bureaucracy" ... the billing is still the same issue after the generics have gotten OTC approval for doctor prescriptions filled by a pharmacist. It's still very common for doctors to prescribe, and pharmacists to fill OTC drugs, and the payments go through the same insurance company red tape as any other Rx.

And yet, the article from GP shows that the added cost of this insurance billing bureaucracy is still less than the added cost of consumer shelf-branding markups.

> “CGMs can be a powerful tool to help monitor blood glucose. Today’s clearance expands access to these devices by allowing individuals to purchase a CGM without the involvement of a health care provider,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “Giving more individuals valuable information about their health, regardless of their access to a doctor or health insurance, is an important step forward in advancing health equity for U.S. patients.”

Says nothing about it being cheaper; and honestly, taking the requirement to see a doctor out of it may end up reducing the total cost for a patient anyways.

Is the FDA capturing any of that markup somehow? I fail to see how it would impact their decision process on approving if it had no impact on their incentives.

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