My wife gets regular infusions and had to ration for months; the local hospital canceled elective surgeries as well.
For those downvoting me, here's the American Medical Association:
https://www.ama-assn.org/delivering-care/public-health/fixin...
> The Biden administration has invoked the Defense Production Act “to help speed up recovery efforts and get that North Cove plant back up and running,” Garcia noted. Hospitals, meanwhile, are turning to alternative options such as hydration tablets and sports drinks while prioritizing IV fluids for the higher-acuity and higher-risk patients.
> The FDA, meanwhile, has “released new guidance that eases up on rules regarding the compounding of IV solutions,” she added. “That's to make it easier for hospitals and other facilities to do this during the shortage period.”
NBC https://www.nbcnews.com/health/health-news/long-helene-iv-fl...:
> So, why are these essential fluids — a lifeline for hospitals — so hard to come by?
> As is often the case with drug shortages, it comes down to money, and IV fluids don’t bring in much of it for manufacturers, said Erin Fox, senior pharmacy director at the University of Utah Health.
> “These are life-saving products, but at the same time these are absolutely treated as kind of commodities,” Fox said.
> The high barrier to entry — including the time and cost required to meet the regulatory requirements for setting up a manufacturing facility — along with the pressure to keep prices low, means drugmakers aren’t really motivated to jump into the market, Fox said.
NPR: https://www.npr.org/sections/shots-health-news/2024/10/11/nx...
> On Wednesday, the Food and Drug Administration announced it has authorized 19 IV products for temporary importation from Canada, China, Ireland and the U.K.
having worked in the space... you are at the level of knowledge of "you don't know what you don't know." it's regulated for good reason. WFI is ultra pure water and costs quite a bit of money to make and is one of the main ingredients in a lot of pharmaceuticals.
IV fluids aren't difficult to produce, but it IS difficult to produce PACKAGED IV fluids consistently, every time, in such a way that they don't make people sick.
Because that is difficult and important, there are tests and certifications. In turn the tests and certifications are difficult - and yes at this point there is extra cost, and that extra cost becomes a moat, which drives up price.
Unfortunately, the moat is both consumer protection and rent seeking business advantage. That is, part of the excess cost beyond the base ingredients goes to protecting consumers, however a lot of the excess cost comes from the fact that not everyone is willing to undergo all of the paperwork and process that consumers and insurance have asked the government to require.
You are not completely wrong, just mostly wrong.
"Pure government regulation" is so rare as to be non-existent in most people's daily life. "Government regulation" is someone's moat. Sometimes it's a consumer group, sometimes it's special interest, sometimes it's a business. Very rarely it is for the government's own sake.
I’ve worked in parenteral pharmaceutical manufacturing (IV drugs) and making sterile products at scale is actually quite hard to do.
It is true the ingredients are basic. Where the challenge comes in is running a manufacturing line where all products that come out the other end are guaranteed to be 100% sterile.
And actually calling them “sterile” isn’t true, they need to be “pyrogen-free” or "aseptic". Pyrogens are basically “fever causing” materials like fragments of bacterial cell walls.
You can’t just mix up the ingredients and then sterilize it (heat or radiation). There may not be any viable infectious agents (bacteria or viruses) but it will contain fragments like LPS (lipopolysaccharides) which will make patients very sick.
And the finished product is a fantastic growth medium for bacteria since it doesn't typically contain any preservatives to prevent bacterial growth.
So the process requires a number of steps to remove all pyrogens (micro pore filtration) on a large manufacturing plant which is quite challenging when you’re dealing with ten thousand liter process vessels then filling millions of IV bags. Every vessel, line, filter, connection and package in the plant is a potential source of contamination. You also need extensive testing throughout the process to ensure nothing goes wrong.
It’s one of the reason why there are often shortages of generic IV drugs. It’s expensive to set up and requires expertise to maintain the process. If problems happen, production lines can be shutdown for months while the issue is fixed. As a result a lot of manufacturers just exit the market when prices drop because the profit margin gets eaten up every time an issue arises.
You can read the FDA's guidance document and the cGMP guidance to get a sense as to the complexity.
It is very much known that you can arbitrage medical costs, drug costs by going to Canada and Mexico. It is very much also very simple to research, search and find vendors or manufacturers located outside different geographic areas.
Therefore, your "qualifications" rebuttal becomes nil, this is basic adult literacy.
Call it economics/subsitution research, call it being informed, or just googling.
It is very much not ignorance but a very valid question to a very valid concern - most market restrictions are not because of "safety" (unfortunately, but it does become a boogey man) or "non-availability" (there is supply, but it isn't allowed.) but because it benefits some one/some company financially.
Bread has four ingredients. Flour, water, salt, and yeast. Do you think all breads are therefore the same?
We had similar situation in communist czechoslovakia. There was a plan to manufacture female hygiene products, in a single factory for entire country. This factory burned down on second year of five year plan. So for some time our ladies were forced to use toilet paper. We still managed to make IV fluids though!
My guess US planning is a bit similar. Too special to import medical supplies from neighbours or from Europe.
https://www.reuters.com/business/healthcare-pharmaceuticals/...
Losing 60% of production in a country of 350M people is hard to make up from elsewhere, though.
The US is unlikely to be unique in this sort of thing. Everyone depends on Taiwan for chips, for example.
It looks like the problem is a for-profit health system. I want IV fluids, injected directly into the bloodstream of very sick people, to be very carefully regulated.