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Comment by RheingoldRiver | Hacker News Reader

> It took generic $5 inhalers off the market and replaced them with $95 inhalers.

OOTL, what is stopping companies from making generics of the older version & patients just not using the new version?

It is illegal to use the previous propellant, so they can’t be manufactured anymore.

Where can I read more about this? If that’s true, it seems like a problem of over-regulation, not drug companies being exploitative.

R-12 is banned for manufacture by international treaty (which carries the force of law): https://en.wikipedia.org/wiki/Dichlorodifluoromethane

https://en.wikipedia.org/wiki/Dichlorodifluoromethane

> In compliance with the Montreal Protocol, its manufacture was banned in developed countries (non-article 5 countries) in 1996, and in developing countries (Article 5 countries) in 2010 out of concerns about its damaging effect on the ozone layer.

Seems a reasonable regulation to me.

Not reasonable if it prevents the minuscule amounts required for inhalers.

A more nuanced regulation would limit the production volume if there are still valid use cases.

The sentence immediately after the quoted section provides additional nuance, reading as follows:

> Its only allowed usage is as a fire retardant in submarines and aircraft.

There is no reason to continue the use of R-12 in inhalers when R-134a is a drop-in replacement, though you're welcome to do your own research if you still disagree with the legislation.

> There is no reason to continue the use of R-12 in inhalers when R-134a is a drop-in replacement, though you're welcome to do your own research if you still disagree with the legislation.

I disagree with that statement. As mentioned above if it causes the drug companies to be able to re-patent the same drug again at 20x the price, then it’s not a drop-in replacement.

If this is a propellant used in life-saving medicine and this regulation increased the price then it’s a bad regulation, period. If there’s already an exception to be used as a fire retardant then medical applications can be included in there as well. The immeasurable output from an inhaler isn’t going to damage the ozone layer.

Over time you can migrate the production to the newer chemical and still achieve the same effect without hiking the price, since the drug companies won’t charge 20x the price if the cheaper generic still exists.

Politicians unfortunately do this all the time where they create a regulation without going through an analysis of tangentially related cause and effect.

The problem is the patent, not the regulation

You’re correct that the patent should’ve never been awarded, but the regulation still caused a problem today - something that could’ve been avoided if a cause-effect analysis was done. This is a problem statement that is applicable to most regulation today.

This is why blanket bans are almost always bad.

That logic cuts both ways as a tool to prevent important regulation that harms a small interest for the public benefit.

That’s why you an analyze cause and effect. You should target the highest driving factor and ban that, not blanket ban and catch things in the crossfire that don’t make a statistical difference to what you’re trying to improve - that way you don’t cause ill effects elsewhere.

You might not get the price-benefits you expect.

If the only remaining allowed use for R-12 is in inhalers, the manufacturing volume might be so low that you end up in a similar situation to today: Fewer manufacturers (likely just one), higher prices, and supply-chain issues.

You can read about it in the wikipedia page [0]. This refrigerant isn't manufactured anywhere anymore because it was creating a hole in the ozone layer.

[0] https://en.wikipedia.org/wiki/Dichlorodifluoromethane

The first I know about is the montreal protocol for the ozone. Countries (all 19X of them) agreed banned CFCs and pharmaceutical products weren't excluded.

Well, patents are only supposed to be granted if an idea is non-obvious to someone skilled in the field. Replacing an illegal propellant with a legal one should be obvious to anyone in the field, so this patent deserves to be challenged.

and while we're at it, maybe punish the ones who granted it? perhaps even make the people who did it, and anyone who knew of it, and didnt try combat it PERSONALLY liable for it?

It is true, which implies your understanding of the situation is confused. I dislike bigPharma as well, but I at least point the blame canon at the right target and not just indiscriminately point it at the person I dislike the most in the fight.

That's just your bias.

> Several inhaler manufacturers formed the International Pharmaceutical Aerosol Consortium, a lobbying group dedicated to, among other goals, persuading lawmakers and regulators to ban inhalers with CFCs. The group spent hundreds of thousands of dollars, and in 2005, the FDA ruled that CFC inhalers would be phased out beginning in 2009. As a result of the ban, newer albuterol products — including Proventil HFA (which was approved in 1996), Ventolin HFA (approved in 2001), and ProAir HFA (approved in 2004) — would be free from competition from inexpensive CFC-containing generics. HFA inhalers were protected by new patents on both the HFA propellants and the devices themselves, and they generally cost much more than generic CFC inhalers.

"Product Hopping in the Drug Industry - Lessons from Albuterol"

N Engl J Med. 2022 Sep 29;387(13):1153-1156. doi: 10.1056/NEJMp2208613. Epub 2022 Sep 24.

https://pubmed.ncbi.nlm.nih.gov/36155425/

[pdf] https://wvpublic.org/wp-content/uploads/2023/06/Tu-2022-Wout...

Among other things, they pay them not to.

https://www.nbcnews.com/news/amp/ncna447916

> Known as "reverse settlement payments," or "pay-to-delay" deals, the financial arrangements are a unique but common practice in the pharmaceutical industry. Essentially, they allow drug manufacturers in some instances to pay competitors not to manufacture generic versions of their products, thereby ensuring that they maintain patent protection for as long as possible.

How is this NOT a violation of antitrust laws? How does this not hurt market competition or even more basic, how is this not collusion or a price cartel?

It is. They make far more money than they lose in penalties when officials bother enforcing on any technical violations. It's such a huge pain in the ass to try enforcing these little violations and there's so much corruption and bureaucracy preventing effective enforcement of the big ones that any action against these companies at all is a noteworthy accomplishment for a regulatory agency.

Lina Khan is punching way above her weight and using the FTC to do the job it's ostensibly designed for. She's aggressively poking some very ornery and obnoxious bears, hopefully some precedents will be set and corruption repaired. Most regulators are incentivized to play within the whole wink-wink-nod-nod government revolving door system of crony capitalism, but Khan doesn't seem to be playing that game, which is nice.

Drug salespeople, doctors, pharmacists, and insurance companies.

If you get a prescription for a ProAir HFA inhaler, which is parented because it uses R134a, even if you did want to do your own research and evaluate whether the generic with the different propellant would work you can't just go buy the generic, you have to do extra work to get a prescription that applies.

Doctors don't write prescriptions for albuterol sulfate, they write ProAir HFA and it's up to the consumer to push back. They don't even advise taking OTC ibuprofen or pseudoephedrine, they say Advil and Sudafed. It's a pet peeve of mine, but it seems I'm the weird one in that respect...

In Canada pharmacists will generally just ignore brand names written by MDs and fill with generics unless there’s a known difference or the patient specifically asks (and is willing to pay more).

It’s similar in both countries with some slight variation in the US depending on the state.

Unless the prescription is marked as “do not substitute” pharmacists generally have the discretion to substitute for a generic, in fact a few states require it.

In the US if a doctor prescribed a brand name, the Rx works for the generic as well. For me, it usually happens automatically at the pharmacy with no action on my end.

If you don't need to be able to carry it around, albuterol solution is still cheaply available for nebulizers - but you'll need a nebulizer (which isn't portable) to use it.

ProAir HFA is one in which the legally permissible substitutions by the pharmacist are limited, largely because the old propellant (and thus generics based on it) is not legal for sale.

We use trade names because they're shorter and easier for patients (and doctors) to remember. Outside of a few specialized areas - epilepsy, warfarin, thyroid hormone - very very few doctors use branded products when a generic is available (and there's nothing wrong with the generics there, except that you need to get the same product every time to titrate the dose, and unless you know that X pharmacy will only stock the drug from Y manufacturer, it's a crapshoot).

A group of pharmaceutical companies that held patents for non-CFC inhalers got together and created the "International Pharmaceutical Aerosol Consortium" to lobby in order to get the generic version banned.

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