[oezi]

The doctors are assuming liability or let the patient sign waivers, which I guess is fine. But the lack of a pathway prevents a lot of commercial possibilities. For instance it is almost impossible to build a business around supporting off-label use cases (for instance selling necessary accessories).

[jnovek]

I have some difficult-to-treat medical issues and about 1/3 of the handful of pills I take every day are off-label. I think when you get into less common medical concerns off-label use becomes much, much more frequent.

E.g. gabapentin is an anti-seizure medication that has been found to reduce neuropathic pain as well. It has shot up to the 5th most prescribed medication in the last decade as it has replaced long-term opioid use for new chronic neuropathic pain patients. This is 100% off-label and is prescribed by everyone from NPs all the way up to neurosurgeons for this purpose.

I’ve never been asked to sign a waiver and I can’t imagine that for-profit hospitals would allow their doctors to prescribe off-label medications willy-nilly if they represented big liability. (I don’t know this for sure, this is just what my experience implies.)

[fc417fc802]

> I’ve never been asked to sign a waiver

That presumably has to do with the risk profile of the medications you've taken. If there was a high risk of devastating side effects and it was off label presumably the prescriber wouldn't be willing to take on the liability.

[nradov]

Do you know that for a fact or are you just guessing?

[mothballed]

I would wager if those waivers actually did anything they'd boilerplate a generic version of it in the legal mumbo jumbo you have to sign even if you come in to have the doctor look at a stubbed toe.

[overgard]

That's not my experience at all, my doctor's have prescribed plenty of things off label. No special waivers.

[Aurornis]

Off label prescribing is extremely common.

This isn’t a new or novel concept. Doctors manage patients with off-label prescriptions all day long.

[mothballed]

To get a drug approved you have to go through regulatory approval for a particular use. If the fuck-fuck game is you can just off-label for whatever but only if first approved by the FDA to solve some other problem, why not just bypass the bullshit and get straight to the point of approving the drug without any approved use? Oh yes, because that assures the barriers to entry are arbitrarily higher, and Pfizer and other ilk can insulate themselves from competition. Thanks FDA!

[_DeadFred_]

Like a lot of the systems we have today, it grew from good intentions. We need to figure out a way to refresh our systems without throwing them away. The current system does provide new drugs and benefit. The question is is it limiting, and are the tradeoff of those limits worth while.

In other words it takes hard work, with politically risky outcomes and an upside that becomes invisible as far as political careers go. We need to figure out how to refresh our systems in an environment where that type of thing just stumbles along. Maybe a couple of politicians elected who have lost out because of the status quo, but that want to improve it not throw it away. Maybe working with them to motivate them to take it on as a pet project and move things.

[mothballed]

If we're just letting doctors yolo off-label, i have no problem with that, but that functionally relegates FDA protections to testing risk profile at some particular dose regimen, with a bunch of extra bullshit tacked on that is highly inefficient process for off-label use even if partially applicable.

It's pretty clear if you're allowing off-label use you can just gate dose-risk profile at one gate and then just add additional gates for on-label uses if you want to approve one.

Of course the issue is the FDA regulator gets the hammer and damned if anything goes wrong but nothing good happens to them if they approve something. So they have no real incentive to approve anything except ideological satisfaction to whatever extent it lives within their mind, plus whatever revolving door benefits industry is offering them.

Probably best to reward the FDA employees for approving good drugs so that the prisoners' dilemma doesn't always fall back to erring on the side of denials, and being easier on them for taking some risk that approves bad drugs to the point they're willing to take some risk to let potentially good drugs through. The regulator doesn't get to see all the bad they cause by not approving drugs because that's invisible, and that's the unintended consequence of their activities and something they're not really held to account for.

[toomuchtodo]

> For instance it is almost impossible to build a business around supporting off-label use cases (for instance selling necessary accessories).

There is no need for a business. Off label use is hacking around the existing commercial and regulatory system. The innovation to be had is fixing said commercial and regulatory system, not another business. Make cheap drugs or medical supplies, distribute them to those in need with as little margin and risk to the patient as possible. This is a utility system masquerading as a market. More duct tape by way of new business are suboptimal.

[forgetfreeman]

The business is already built given the drug in question is already being manufactured and available on the market.