I did joke I’m really surprised the vested interests selected someone competent who wants to hold these companies accountable to the public.
They patented inhalers for a second time. It's the exact same drug. The only thing that changed was the propellant. It went from R-12 to R-134a. Everyone who had to switch out R-12 from refrigeration to drug manufacturing switched to R-134a. There was absolutely _nothing_ novel about it.
It was _criminal_ to allow them the second patent for just the propellant change. It took generic $5 inhalers off the market and replaced them with $95 inhalers. It was was one of the most corrupt swindles I've ever personally seen.
It is also interesting when does the social benefit of a drug outweigh the benefit of creating an 'incentive' for drug companies. If GLP-1 drugs are worthy of the hype, we're basically talking about 20 years of unneeded suffering and trillions of dollars of avoidable damage to society all to give a drug company a limited monopoloy. At a certain point the US should just eminent domain the patent, give them some reasonable compensation, and make the drug broadly available to all Americans similar to COVID vaccines.
OOTL, what is stopping companies from making generics of the older version & patients just not using the new version?
"[T]he Orange Book lists patents that are purported to protect each drug. Patent listings and use codes are provided by the drug application owner, and the FDA is obliged to list them. In order for a generic drug manufacturer to win approval of a drug under the Hatch-Waxman Act, the generic manufacturer must certify that they will not launch their generic until after the expiration of the Orange Book-listed patent, or that the patent is invalid, unenforceable, or that the generic product will not infringe the listed patent. "
It sounds like it's easy for manufacturers to.keep adding patents, and the onus is on the generics to make the case that they're not violating. Perhaps most are just scared away, until every listed patent expires (and no new ones are added in the interim)
Note that this comes following “the Commission’s November challenges led to Kaleo Inc., Impax Labs, GlaxoSmithKline, and Glaxo Group delisting patents in response to the FTC’s warning letters” and subsequently “AstraZeneca, Boehringer Ingelheim, and GlaxoSmithKline all announc[ing] commitments to cap inhaler out-of-pocket costs at $35.” This process is precedented with delivering wins.
* Banned non-compete agreements for 40 million workers
* Raised overtime wages for 4 million salaried workers
* Forced airlines to automatically offer refunds for canceled flights and poorly handled baggage
* Banned illegal junk fees in mortgage lending
* Forced divestment of TikTok from Chinese ownership
* Blocked corporate merger in insulation
* Filed to block a corporate merger in fashion
* Announced tariff increases on steel to protect domestic producers
* Announced an end to the duty free period on Chinese solar panels to encourage U.S. manufacturing.
* Passed the first Federal privacy law to stop data brokers from selling sensitive information to China and Russia
It takes a long time to get drugs through trials and get the FDA to approve drugs for new uses. Pharmaceutical companies spend billions on drugs that never make it through trials. If you don’t enforce their patents, companies won’t make new drugs.
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.
> 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.
> Announced tariff increases on steel to protect domestic producers
The Trump Admin went after China far more than Biden has so far, the Democrats were overwhelmingly silent about how that qualified as impressive governing. He needs to do a lot more to bolster US labor and US manufacturing, it's not even a good start yet.
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...
For example, yes Bidens FTC is a standout actor, but 'both sides' just voted to perpetuate overseas wars with more American tax dollars. In terms of the American war machine, it's 100% accurate to say both sides are the same.
I still have a dozen vintage cans of R-12 but no vehicle that uses them.
It wasn’t. She was re-working her game. It looks like it worked and I’ve gone from critic to fan. But the FTC was mockably awful 2020 - 2022, and a non-entity early 2023.
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.
At the risk of sounding dismissive, I'd much rather they banned the selling of sensitive information. Full stop. China and Russia have much less reach into my day-to-day than any of the other buyers much closer to home like a local gov't bodies let alone private corps.
> 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...
These things get planned and implemented far outside of the normal 2/4/6 year election cycle, so it's easy to hide what's actually happening.
Fact is, red tie, blue tie, they're all drinking and merrymaking together, they attend the same parties, they bang the same hookers, and they're in the same corporation's pockets. You have some outliers here and there, but, aside from the occasional filibuster, they do little more than create a spectacle.
None of this is unusual, it's simply how systems of government have been exploited and subverted since humans had the idea the government should exist. That being a somewhat esoteric idea only serves to further the degeneration of a system, much in the same way doing nothing, which is likely what some find so offensive about the idea that "both sides are the same", furthers the degeneration of a system.
From what I understand, Khan was learning to manage a large team. She failed at it. Noticed. Corrected. And seems to have figured it out.
The early FTC was highly centralised. In its new iteration, staffers appear to be trusted to pursue probes on their own. This not only broadens their firepower, but brings to the table staffers’ decades of experience around what wins in court.
SpaceX and numerous other companies were able to draw in billions of dollars of funding for R&D to chase after US Government contracts that could only be won by proving massive technological feats (reusable rockets, etc).
Hypothetically, it seems we could do something similar for drugs. Instead of "If you make a medicine that works, you get a monopoly to sell it for X years" it could just be "If you make a medicine that works, you get a check for $X, and then the drug is immediately generic".
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.
The exceptional people were there from the start. In the early days, their complaint was around being locked out of decision making. Khan and a small group ran the FTC like academics.
That failed both internally and in the courts. To her credit, she noticed the failure, regrouped and re-oriented. But the change wasn’t in star hiring but recognising the talent that was being ignored.
- Ending non-competes
- Ending salaries being used to avoid paying overtime
- Un-banning marijuana
- Restoring net neutrality
- Fining carriers for sharing location data
- And now, challenging dumb patents
Despite your cynical take, that looks like a lot of stuff that's good for me as an individual person.
> 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.
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.
This is why blanket bans are almost always bad.
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.
> * Announced tariff increases on steel to protect domestic producers
These are bad things.
For example, many companies that had taken advantage of putting devices into the Hatch-Waxman Orange Book being an unchecked unmonitored way to lay claim took their devices off once they saw the FTC starting to get interested.
Adopting a narrow view of success is detrimental. Yes, it's hard as heck to figure out how to appreciate & be happy for "number of mergers never proposed because the FTChas actually started taking anti-trust seriously again". We will never have hard data. But for sure for sure for sure, companies are being more cautious, are thinking twice before trying to acquire their competitors or buying a company to land horizontal market control.
Even losing is a detriment. The FTC had done nothing under Borkism. It was free reign. Even winning to the FTC isn't fun. It's expensive as heck, and there's a ton of discovery that happens & sheds light in a lot of dark dark places in your corporation. And other people see, hey, the FTC is out there, they're doing things, and maybe we won't get as lucky.
Last, people act like, oh, the FTC lost, they must be incompetent & unable to build cases, but there's a ton of random chance & whim that goes into each case; replay a case in another courtroom or with different judges or juries and who knows what would have happenen.
Judge for life is a terrible precedent. Not that far from kings.
Especially the republican judges who take lavish trips funded by billionaires. Clear conflict of interest in open.
The harm is diffused among many, the benefits accumulates to a few.
https://taxfoundation.org/research/all/federal/section-232-t...
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).