FDA Issues First Approval for Mass Drug Imports To States From Canada (nytimes.com) 83
The Food and Drug Administration has allowed Florida to import millions of dollars worth of medications from Canada at far lower prices than in the United States, overriding fierce decades-long objections from the pharmaceutical industry. From a report: The approval, issued in a letter to Florida Friday, is a major policy shift for the United States, and supporters hope it will be a significant step forward in the long and largely unsuccessful effort to rein in drug prices. Individuals in the United States are allowed to buy directly from Canadian pharmacies, but states have long wanted to be able to purchase medicines in bulk for their Medicaid programs, government clinics and prisons from Canadian wholesalers.
Florida has estimated that it could save up to $150 million in its first year of the program, importing medicines that treat H.I.V., AIDS, diabetes, hepatitis C and psychiatric conditions. Other states have applied to the F.D.A. to set up similar programs. But significant hurdles remain. The pharmaceutical industry's major lobbying organization, the Pharmaceutical Research and Manufacturers of America, or PhRMA, which has sued over previous importation efforts, is expected to file suit to prevent the Florida plan from going into effect. Some drug manufacturers have agreements with Canadian wholesalers not to export their medicines, and the Canadian government has already taken steps to block the export of prescription drugs that are in short supply.
Florida has estimated that it could save up to $150 million in its first year of the program, importing medicines that treat H.I.V., AIDS, diabetes, hepatitis C and psychiatric conditions. Other states have applied to the F.D.A. to set up similar programs. But significant hurdles remain. The pharmaceutical industry's major lobbying organization, the Pharmaceutical Research and Manufacturers of America, or PhRMA, which has sued over previous importation efforts, is expected to file suit to prevent the Florida plan from going into effect. Some drug manufacturers have agreements with Canadian wholesalers not to export their medicines, and the Canadian government has already taken steps to block the export of prescription drugs that are in short supply.
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It's because the average age driver in Florida is about 87.
Seriously, though, the drivers here do suck and in a different way than California where I lived most of my life.
In California the drivers are simply incompetent. They do shit like mass tail gate at 70mph during the first rain when the roads are super oily. That's just dumb and unsafe.
In Florida, they come in 2 varieties. The constant tailgaters/cut-offers who try to wedge their way through in medium-high traffic when there's literally no where f
PhRMA (Score:3, Interesting)
It was said that officers of the De Beers company were instructed not to visit the USA unless absolutely necessary. But if they did and then suspected that they were about to be apprehended, they should make their way to O'Hare airport. Due to it's heavy passenger volume, that was believed to offer the best change of escaping anti-trust warrants.
Re:Nobody works for free (Score:4, Insightful)
The boot licker speaks.
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I doubt they are taking a loss selling in CA.
They are not getting the margins they do in the USA and it makes the time to break even when you amortize the development costs much longer.
I don't think we will see thee products pulled, It would be political suicide for the drug companies. Why we will see is new drugs not being offered in the CA market, or only being offered after some years have gone by. We will probably see minimal reformulations of some popular money makers to get the lasted and greatest
Cost Basis: R&D + production OR production o (Score:2, Interesting)
Re:Cost Basis: R&D + production OR production (Score:5, Interesting)
Here’s a thought. How about pharmaceutical companies stop spending billions on advertising? It’s literally a new drug every week on tv. Plus this is the only developed country where it’s legal. Nowhere else do drug companies tell consumers to ask for their products totally sidestepping those pesky physicians.
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Asking a physician for a particular drug isn't "sidestepping doctors," since the doctor has the option of prescribing or not prescribing the requested drug...
What will likely happen is that foreign countries will see their steep discounts relative to US drug prices will shrink, ultimately increasing Pharma companies margins and profits overall.
Canada can't force a pharma to sell a product in Canada, it can attract pharma to sell based on volume - ultimately Pharma has the upper hand... Say Canada demanded t
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Canada can't force a pharma to sell a product in Canada, it can attract pharma to sell based on volume - ultimately Pharma has the upper hand... Say Canada demanded too steep a discount compared to US drug prices, Pharma could simply pull the drug from the Canadian market - what would Canada do for a non-generic compound? Violate US Patents & copyrights and produce knock-off drugs in Canada? Import from elsewhere? Or, perhaps, just shift patients to other, less-effective compounds?
That's not true, what Canada and many other nations can and often do when pharma companies want to play silly buggers is compulsorily acquire the medication. The government can literally force the sale, sometimes going as far as to manufacture it locally (for the most part, just contract it out to another company who's not playing silly buggers) under a compulsory license.
So it's a choice of "sell it to us at a fair price or we'll make it ourselves (with blackjack and hookers)", if the pharma company pla
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Here’s a thought. How about pharmaceutical companies stop spending billions on advertising?
That does not solve the who pays for R&D problem.
Username (Score:2, Insightful)
USA prices down, EU/Can up, as R&D spread (Score:5, Informative)
If the US can import from overseas this US-pays-for-R&D model will have to end. US prices will decline and Canadian and European prices will rise as R&D expenses get distributed globally.
Re:USA prices down, EU/Can up, as R&D spread (Score:5, Informative)
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Yeah the government-granted monopolies charge the maximum that won't reduce profits. If it is 1000x the manufacturing + R&D costs great, if it doesn't cover the R&D they will still sell if it at least covers the manufacturing costs -- the R&D costs have nothing to do with the maximum price that the market will bear. That a government-granted monopoly is gauging the government granting its monopoly is just a bit of irony.
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... if it doesn't cover the R&D they will still sell if it at least covers the manufacturing costs ...
Such "ignore the sunken costs" logic ignore the reality that we have a pipeline here. That one generation of drugs pays for the R&D costs of the next generation of drugs. You could engage in the logic you mention but then you have not funds to pay for the next generation of drugs and the company is doomed.
R&D costs have nothing to do with the maximum price that the market will bear.
They absolutely do if you want the company to survive and develop and product drugs in the fuure.
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Go look at a P&L statement for Pfizer. They made enough money in 2022 to pay for health insurance for every man, woman and child in the entire US for a month, and decent insurance to boot. There's only one way to put it: we're being gouged.
They need that money to pay the up front R&D costs for current drugs under development. Pharma profits are like Social Security, one generation pays the costs of a different generation, not itself.
With your plan there would be no funds for R&D.
Re:USA prices down, EU/Can up, as R&D spread (Score:4, Informative)
Production costs peanuts. When prices are guided by production (the case of generics), you pay fractions of a dollar per pill. Commodity generic medications like paracetamol pills cost literally less than a bag of peanuts.
Branded medications are sold at market price everywhere, USA, EU and elsewhere; market prices is what varies due to local constraints, such as willingness to pay and market regulations. Developed countries (except USA?) have regulated markets with a single payer, so BigPharma has to negotiate with the state-owned social security which handles a very large fraction of all healthcare in a country, so BigPharma is not in a strong situation.
Disruptive medicines are priced at a percentage of what it would cost to handle a patient without a medicine, e.g. for a potential AIDS treatment BigPharma goes to the German Government and says if it costs 10 million (to the single payer) to manage an AIDS patient along their 40 years life expectancy then our cure for 5 million euros is a great deal. Then they go to the government of Greece (less rich) where the cost of managing the AIDS patient would be e.g. 4 million over the same 40 years (because Greece is so much less rich and nurse/doctor salaries are lower), so they try to charge 2 million for the same pill. (Dummy numbers for the example.)
There are specific examples where a EU government (the ministry of health which manages the state social security) says "you must be joking we'll only pay 1/10th of that" and it takes 3 years of negotiations to settle a final price and approve the medicine, while others (richer) governments accept the initial offer so they have the treatment faster.
In USA there is zero incentive to price lower; hospitals don't care, it's managed by insurance. Insurance is happy to manage larger amounts, because their profit is in proportion of the amounts they handle. If you have a healthcare idea that saves money, you basically can't sell it in USA, VCs from USA won't trust money on you; you won't have a medicine market for a product that is e.g. 50% cheaper than the others, it won't work; To the contrary they want you to price as high as you can so they get a higher return on investment.
Of course in the end it has to cover R_and_D but that's not the driving factor. Maybe R_and_D costs different in different countries, at least the cost of liability insurance can be expected to be much higher in USA. Also there are smaller pharma doing research in EU and they don't price their products at absurd levels.
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Production costs peanuts.
Not true - while lots of compounds are simple chemical formulas (aspirin, for example), lots and lots of drugs have very complex production requirements. Not every drug is a tablet or capsule containing one or two simple chemical compounds.
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Production costs peanuts. When prices are guided by production (the case of generics), you pay fractions of a dollar per pill.
Well production in this case includes buildings and equipment, the drug's share of corporate overhead, etc. Its not the incremental costs of making 1M more pills.
Commodity generic medications ...
Often benefit from the lower costs of product outside of the US or EU.
Developed countries (except USA?) have regulated markets with a single payer, so BigPharma has to negotiate with the state-owned social security which handles a very large fraction of all healthcare in a country, so BigPharma is not in a strong situation.
Its not that simple. Its not that they are unable to so no to state-owned buyers. Its that if they can get the US to pay for all the R&D they can now meed the lower expectations of that government without hurting margins. The governments know they are freeloading to get their
US exceptionalism? (Score:1)
Also, the US isn't the only underwriter of R&D. European Investment Bank and other governments can't be so easily discounted. Particularly i
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The reason Canadian drugs are cheaper is because they have anti-price-gouging laws and since the provinces buy Rx in bulk they are able to negotiate lower prices by leverage their buying power.
Higher prices will not be price gouging when they have to start including R&D. R&D is a legitimate expense. Buying power doesn't mean a damn thing if the producer loses money. The lower current prices are dependent on the cost being R&D free. If US states can get non-R&D pricing the system will collapse. Reform can only result in lower prices for the US and higher for Canada.
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Marketing costs are several times higher than R&D costs and in Europe advertising prescription drugs is usually forbidden. The US customers are not paying for the R&D, they are paying for the TV ads they get bombarded with.
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Marketing costs are several times higher than R&D costs and in Europe advertising prescription drugs is usually forbidden. The US customers are not paying for the R&D, they are paying for the TV ads they get bombarded with.
They are paying for both, and the R&D costs are not something options like TV ads. One generation of pharma products has to pay for the R&D of the next, and that includes all those products that failed during development and failed in the market. Its like venture capital, you need a big winner to pay for all the failures.
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But we can at least stop subsidizing Canada (and apparently the entire world since everyone else pays less). Meanwhile, if big pharma tries to cut Canada off, they'll bust the patents and fulfill their need through contract manufacturing.
I doubt very much they're taking a loss in Canada. They're just accepting a lesser profit because it's better than nothing.
Re: Nobody works for free (Score:2)
Youâ(TM)re not subsiding canada. Youâ(TM)re being bent over by the medical industry and they ate charging you for the lube.
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The ramifications of Canada violating US patents and copyrights would be significant. Our trading partner to the north would soon find their products tariffed, their favored trading-partner status impacted, and relations with the US generally impacted. Canada can act as independent as they want, but who gets hurt if the automakers pull production from Canadian factories, if we raise tariffs on imported oil and forestry products?
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The thing is, it wouldn't stop at Canada. Close off Canada for Americans needing drugs and they'll go to Mexico, India, any country in the EU, etc. Drug prices in the U.S. are the highest in the world, so the whole world looks like a better place to buy drugs.
Beyond that, how well do you think the U.S. would do punishing Canada for assuring their people a supply of a needed drug that the patent holder refuses to sell to them? What will the U.S. do when a non-U.S. pharma company produces a new breakthrough d
Re:Nobody works for free (Score:5, Interesting)
If that was true, Canada's prices for drugs would be lower than anywhere in the world. However, it isn't, it's that Canada's prices are among the highest in the world, minus the US.
It's just that Canada is a trusted place where you can get the same drugs cheaper. After all, why not get the drugs in Mexico, where they're cheaper than Canada (and some Canadians do)?
Or from Europe, where they're cheaper than Canada?
The reason drug prices are so expensive in the US is not subsidy - a new drug's cost is around 20% R&D and the rest... marketing. They spend billions on drugs, and most of that money is spent on shiny ads on why you need to get your doctor to prescribe it to you.
There is no reason other than pure greed in the US - after all, did insulin prices jump 800%? No, it didn't, but the drug companies decided that they wanted more money and it was easier that way.
In fact, it's not a panacea - in Canada, the drugs are negotiated by the province who buys them on behalf of pharmacies. The pharmacies then buy those drugs from the province at a fixed price. And many provinces have seen the future and require pharmacies to not only ensure a prescription is Canadian, but that the recipient is Canadian as well. Anyone else, say, a traveller can get some drugs, but only a limited supply. So a Canadian might be able to get 3 months supply, but an American, they may only get a week's supply before getting a refill. And yes, online pharmacies exist with the same restrictions. And since the source of drugs are controlled, if pharmacies are doing wrong, they may get cut off.
No subsidy involved - Americans are just getting screwed over because there is no reason that drug prices should jump 800% to 1200% in a year other than profit.
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Citation for this one-year 800% increase in the price of insulin?
Insulin in a vial has not gone up 800%, insulin in high-tech, self-dosing syringes that don't require refrigeration and simplify injection have gone up in price, but that's likely because insulin itself is so cheap, paying for the syringe is simply a multiple of a very cheap compound. Want/need your shelf-stable insulin to come in a cartridge for a proprietary insulin pump, that's just gonna be more expensive than a vial of generic insulin.
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It's because they can afford to supply a small market at a loss knowing they can make up for it by charging Americans more.
Rest assured they are doing nothing at a loss. The profits are simply not quite as obscene in the rest of the world where people are not as willing to bend over.
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I'm pleased you care about Canadian health-care.
Look, everyone: The first US corporations doing something that benefits only the rest of the world.
I'd celebrate but I need to buy binoculars: I'm looking for 3 wise men and 1 virgin, in a barn.
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"I'd celebrate but I need to buy binoculars: I'm looking for 3 wise men and 1 virgin, in a barn."
Rule 34?
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Rule 34?
One doesn't have to go far to hear of Santa porn, why is Madonna porn never mentioned? Also, why is focus on three strange men, not the "husband"? It shows what we're really think of female teenagers.
My thought always is, a teenager spending the night with men who treat her like an adult: It's obvious what happens next.
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Nah. Canada just has higher bargaining power when it's on behalf of the entire province/country in those cases.
That said, the US is more than capable of just doing it itself. It doesn't need to import from Canada, all it has to do is get all the medical facilities to sign on to only purchasing from the government stockpile and have the government negotiate directly with the pharmaceutical industry.
The only reason they won't is because states run by right-wing morons think medical care is a choice. Yeah, a c
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As an American, I fail to see the benefit of the US government controlling all drug sales and distribution directly as you describe.
US politicians can talk a good game on the campaign trail ("if you like your doctor, you can keep your doctor" and "if you like your insurance plan you can keep it" ring a bell?) but when push comes to shove, you get debacles like the rollout of healthcare.gov (remember that?) or more recently the discovery that no one in government prepared for the inevitable virus in 2019 des
Confused state (Score:2)
So they refused to expand Medicaid under the Affordable Care Act but they are ok with importing drugs from Canada.
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They refused to spend more money on healthcare, now they're trying to save money on healthcare?
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I'm sure if you put it to an actual public vote Florida would overwhelmingly approve of expanding Medicaid. The problem is that a significant portion of the electorate doesn't grasp the concept of how representative democracy means that by voting for the guy with a (R) next to his name, they're never going to get it.
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The voters know who they're voting for.
Expanding Medicaid subjects the states to spiraling healthcare costs, that's typically the reason some states refused. Kinda like the famous Bill Clinton "100,000 new cops on the street program" - Clinton/Federal Govt largely covered salaries for the new officers for the first few years, then states were on the hook for 100% of the additional officers salaries, and for many states that was not affordable. Or when the federal gov't offers to cover a significant portion
Bad for Canadians (Score:3)
This is bad for Canadians.
The drug companies will raise the prices of drugs in Canada to US level prices as the US import orders will eventually flood out the domestic Canadian orders, especially if other states do this too (even just Florida, is more than half the population of all of Canada).
Re:Bad for Canadians (Score:4, Interesting)
Nope, not really.
It doesn't matter what the "FDA" decides - they don't have jurisdiction in Canada. They can "allow" whatever imports to the US they want - but it won't make a lick of difference if the wholesale export of those drugs FROM Canada are controlled by the Canadian government (hint: they are)
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True, FDA "allows" and Canada "regulates", but pharma has the ultimate leverage - if pharma decides to simply not meet Canada's price demands on patented/copyright-protected medications, what will Canada do? Produce their own knock-offs and start a trade war with US? Buy the drugs from other countries (like Mexico)?
Canada can't "demand" Pharma sell them drugs at whatever price Canada wants to pay...
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Canada can't "demand" Pharma sell them drugs at whatever price Canada wants to pay...
You are wrong. Canada does exactly that. Our drug prices are actually reasonable because the government regulates the price. The US has *actual laws* PREVENTING the government from regulating drug prices FFS...
Why in the world USians believe they're going to be able to buy drugs at the price enforced by the Canadian government when they're not Canadians is completely ludicrous.
Get a real health care system and stop trying to foist your sick onto other countries.
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We could cut them off the research that Canadian Universities do on drugs and basically give to the drug companies. Sure it's only about 10% of what American tax payers contribute which is inline with our size difference.
Still waiting for that dollar payment for the insulin patent.
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Nope, not really.
It doesn't matter what the "FDA" decides - they don't have jurisdiction in Canada. They can "allow" whatever imports to the US they want - but it won't make a lick of difference if the wholesale export of those drugs FROM Canada are controlled by the Canadian government (hint: they are)
I think he means basic free market economics.
Canada, like most other western nations not only negotiate a price for a medication with pharma companies, they also tend to negotiate quantities, this is what makes the UK's NHS one of the most aggressive negotiators, sheer buying power. They'll shave off a percent or two because we can make it up in volume.
So if Americans start going over the border to buy medications that Canada has negotiated for itself because it's cheaper than buying them locally, it
Bad for Canadians but more equitable (Score:2)
This is bad for Canadians.
But more equitable as R&D costs are spread globally rather than being billed primarily to US consumers and federal and state governments.
Maybe Not Bad for Canadians (Score:1)
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You don't think Pharma will notice the matching drop in US sales and make the connection?
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Socialists rejoice! (Score:2, Interesting)
In other words, one vaccine designed to mitigate death from a virus is bad because it has the letters RNA in it, but all those other drugs which make changes to the chemicals and fluids in the human body are perfectly sound so long as you can get them for cheap.
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Just like all those MAGAs who whine and moan about how bad President Biden is boycott the stock market so their investments aren't tainted.
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In other words, one vaccine designed to mitigate death from a virus is bad because it has the letters RNA in it, but all those other drugs which make changes to the chemicals and fluids in the human body are perfectly sound so long as you can get them for cheap.
Yes, but only if the person taking them doesn't enjoy it too much.
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Remember when the c19 shot was supposed to stop transmission ( don't say otherwise, just don't; we all have the receipts )?
Yup, and that is exactly what they do [usatoday.com].
All three COVID-19 vaccines authorized in the U.S. were designed to prevent severe infection, hospitalization and death. But experts and public health officials say the shots also protect people from contracting and spreading the virus.
"What we know is that individuals who are vaccinated are much less likely to be infected therefore much less likely to spread the virus," Dr. Amesh Adalja, a senior scholar at the Johns Hopkins Center for Health Security, said in an email. .
. .
"Yes, it is true that vaccinated individuals can also be infected by and spread SARS-CoV-2 to others," Shweta Bansal, an associate professor of biology at Georgetown University, said in an email. "However, the evidence is crystal clear that risk of transmission for a vaccinated individual is significantly lower than for an unvaccinated individual."
Bansal pointed to data from the United Kingdom, which shows the COVID-19 vaccines reduce the chances of getting infected by 50%-75%. A preprint study, also conducted in the U.K., found that two doses of the Pfizer vaccine are 80% effective against preventing all infections with the delta coronavirus variant.
Then it was to prevent death? Guess what, it doesn't.
We have the receipts for that. People who are not vaccinated against covid die at a far higher rate than vaccinated people [scientificamerican.com]. In other words, getting vaccinated does prevent death.
As for the continual bullshit of boosting a company's bottom line, I'm presuming you take no medications of any kind
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This all got a bit wonky when the definition of vaccine went from "prevent disease" to "probably mitigate the symptoms, but not prevent either infection or transmission". The Govt (under Trump and Biden) bought countless billions of vaccine doses before we even knew the efficacy of the vaccines, then, with countless billions tied-up in the billions of doses the gov't pre-purchased in refrigerated storage around the country, suddenly everyone needed to get semi-annually/quarterly vaccine booster to use up th
Insulin (Score:3)
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You think you're sounding smart but that's the Dunning-Kruger kicking in.
FL SG issued a warning over undisclosed SV40 plasmids found in Process II batches which integrate into the DNA and are known cancer-causing agents. We went through this in the 70's.
If you don't know what any of those words mean, look them up - this is genetics I took in high school in the early 90's.
Anyway, Nuremberg demands informed consent for medical experimentation and the established legal penalty for massive abuse is hanging by
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He is calling covid shots “the antichrist”. I wouldn’t trust him to recommend me a flavor of chewing gum, much less medicinal advice. He’s your stereotypical appointment stooge. https://www.thedailybeast.com/... [thedailybeast.com]
Except ... (Score:2, Troll)
Florida has estimated that it could save up to $150 million in its first year of the program, importing medicines that treat H.I.V., AIDS, diabetes, hepatitis C and psychiatric conditions.
Guessing they won't be buying any of the COVID-19 mRNA Vaccines ... Florida State Surgeon General Calls for Halt in the Use of COVID-19 mRNA Vaccines [floridahealth.gov]. Maybe they're hoping to also save some money by letting people die of respiratory illnesses?
Also: Florida surgeon general calls for halt on mRNA COVID vaccines, citing debunked claim [washingtonpost.com] (and others)
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People aren't demanding mRNA vaccines anymore, haven't you noticed? Vaccines our elected official pre-paid for during an election year have been rotting/expiring in countless federal warehouses.
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People aren't demanding mRNA vaccines anymore, haven't you noticed?
All mine have been Moderna and I got my last one with a Flu shot in November 2023 ...
Never any side effects except spending a day in bed with aches and chills.
As a canadian free market advocate (Score:2)
Americans subsidies the rest of the world with the actual commercialization of new drugs and medical procedures. With the exception of Covid when was the last time you used a drug that wasn't certified and production figured out in the USA? P
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If the 10x larger USA buys up Canadian drugs it'll mess up things for Canadians. If you like the free market so much you should move here and discover the bad sides of economic anarchy (aka free market.) The market needs controls just like fire needs to be contained and if you like burning things and getting burned you shouldn't live in Canada. Don't ruin things there, move here... and I'll move up there...
That so-called research is heavily government funded; my local university does such research and han
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The military is a huge massive constant money loser and only helps as an indirect economic stimulus
I don't think anyone was under the impression that the US military was a revenue source for the government. I've seen what a for-profit military looks like, in the book "Catch-22"...
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We're always having people applying business style thinking to everything else but never the military money pit... which costs more than most everything else being debated.
I am fine paying about $8 per year to fund NASA even with it's increased waste and how others build whole businesses on top of the free info and experienced talent they make available for humanity. But we've got a whole line of attack about wasting money on such government bloat and how it doesn't bring in money or needs to somehow...
As
May cause side effects (Score:3, Funny)
The CDC needs to be on the alert for unusual outbreaks of civility in these states.
Canada cannot supply the US. (Score:1)
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Capacity? You source the drugs from America, you don't produce them yourself. As us demands shrink and Canadian demand increases, existing market shares will shift with Canadian consumption increasing in proportion to the reduction in US consumption, maintaining an otherwise stable market size.
But don't worry, it won't happen - the states will use this "authorization" to negotiate better deals directly from Pharma companies, that's what will happen - before states were captive to what Pharma wanted to charg