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On August 28 2016 09:02 Nyxisto wrote:Show nested quote +On August 28 2016 08:50 xDaunt wrote:On August 28 2016 08:47 Nyxisto wrote:
Lobbying is a feature of the free-market, not a bug. Free markets without lobbying don't exist You're missing the point. In a free market, absent government intervention, there would be competitors and lower prices. It's the government regulation that failed. Not the free market. Or they few big firms in the market just collude and charge whatever they want because demand for health services is completely inelastic? The same thing that happens every time when vital resources like water are privatized
Dude, at least take the time to understand the specific circumstances related to Mylan before you default to retarded generalities that are completely inapplicable in this case. Here's a big hint: Mylan wasn't shielded by any IP protections.
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You made a generic point about free markets so I responded in generic fashion. The particular case isn't even that interesting. Generally speaking regulations in sectors like the healthcare market do not lead to a price increase for consumers.
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On August 28 2016 09:15 Nyxisto wrote:
You made a generic point about free markets so I responded in generic fashion. The particular case isn't even that interesting. Generally speaking regulations in sectors like the healthcare market do not lead to a price increase for consumers.
No, go look at my first post. I very directly said what happened in this specific instance. You're the one who has completely failed to show any understanding of what happened.
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I still don't fully understand why another manufacturer can't just create a generic EpiPen and sell it at the old price. It's not under patent as far as I'm aware?
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On August 28 2016 09:26 Belisarius wrote:
I still don't fully understand why another manufacturer can't just create a generic EpiPen and sell it at the old price. It's not under patent as far as I'm aware?
This is exactly my point. It looks like others tried but were unable to get federal approval as a result of Mylan's lobbying. In other words, government regulation (specifically, corruption) was the problem.
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There are some other generics that exist, at markedly lower prices (like what epipen used to sell at). They have a lot less market share, not sure why.
In general, startup time, capital costs, and regulatory compliance make it hard and slow for someone new to go into such business; it'd take a new business years to be up and going.
it's also not always fast to scale up production, it may involve large capital outlays, which could bankrupt the company if the competitor simply drops back to the reasonable price.
some of the issues is cause a couple other competitors were taken out due to regulatory issues, not sure whether those were justified or not as I haven't investigated their cases in detail.
sometimes people aren't comfortable changing brands, or substituting one version for another.
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The FDA is one of the biggest reasons why drugs and treatments are so expensive. The regulatory approval process is absurd. And to make matters worse, companies spend millions lobbying the hell out of the FDA to delay or deny competitors approval of their new products, all of which just further drives up health care costs.
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There was a reddit AMA with a pharma CEO that touched on this the other day.
What stops a company like your from undercutting another company says Mylan for instance, by flooding the market with a cheaper variant of their epipen auto injectors?
First of all Mylan is primarily a generic company and they understand as well as anyone how the generic market works. There is nothing other than technology, intellectual property and manufacturing capability to stop someone from coming up with a cheaper version. In the generic market, having a portfolio of generic products allows large generic companies to have the ability to price below cost on certain SKUs and therefore a small company with only one generic is vulnerable to losing market share and therefore profits.
www.reddit.com
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On August 28 2016 09:49 OuchyDathurts wrote:There was a reddit AMA with a pharma CEO that touched on this the other day.
What stops a company like your from undercutting another company says Mylan for instance, by flooding the market with a cheaper variant of their epipen auto injectors?Show nested quote +First of all Mylan is primarily a generic company and they understand as well as anyone how the generic market works. There is nothing other than technology, intellectual property and manufacturing capability to stop someone from coming up with a cheaper version. In the generic market, having a portfolio of generic products allows large generic companies to have the ability to price below cost on certain SKUs and therefore a small company with only one generic is vulnerable to losing market share and therefore profits. www.reddit.com
Product price clearly isn't the barrier to entry in this instance given how high the mark up is.
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On August 28 2016 09:41 xDaunt wrote:
The FDA is one of the biggest reasons why drugs and treatments are so expensive. The regulatory approval process is absurd. And to make matters worse, companies spend millions lobbying the hell out of the FDA to delay or deny competitors approval of their new products, all of which just further drives up health care costs.
FDA is also the only reason drugs and treatments actually work and aren't contaminated with rat droppings. The feedback loop from market information just isn't fast enough to prevent deaths.
There's a reason we had that huge meningitis outbreak-the injections were from non-FDA regulated pharmaceutical compounding.
So it's kind of a tough situation to deal with (it doesn't help that their hands are tied with respect to things they need to be able to do and untied with respect to things they really shouldn't be doing).
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On August 28 2016 09:59 TheTenthDoc wrote:Show nested quote +On August 28 2016 09:41 xDaunt wrote:
The FDA is one of the biggest reasons why drugs and treatments are so expensive. The regulatory approval process is absurd. And to make matters worse, companies spend millions lobbying the hell out of the FDA to delay or deny competitors approval of their new products, all of which just further drives up health care costs. FDA is also the only reason drugs and treatments actually work and aren't contaminated with rat droppings. There's a reason we had that huge meningitis outbreak-the injections were from non-FDA regulated pharmaceutical compounding. So it's kind of a tough situation to deal with (it doesn't help that their hands are tied with respect to things they need to be able to do and untied with respect to things they really shouldn't be doing).
Have you ever looked at the differences between the FDA regulatory process and what you'll find in the EU?
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On August 28 2016 09:58 xDaunt wrote:Show nested quote +On August 28 2016 09:49 OuchyDathurts wrote:There was a reddit AMA with a pharma CEO that touched on this the other day.
What stops a company like your from undercutting another company says Mylan for instance, by flooding the market with a cheaper variant of their epipen auto injectors?First of all Mylan is primarily a generic company and they understand as well as anyone how the generic market works. There is nothing other than technology, intellectual property and manufacturing capability to stop someone from coming up with a cheaper version. In the generic market, having a portfolio of generic products allows large generic companies to have the ability to price below cost on certain SKUs and therefore a small company with only one generic is vulnerable to losing market share and therefore profits. www.reddit.com Product price clearly isn't the barrier to entry in this instance given how high the mark up is.
you're missing the point daunt; the point is that if another company tries to butt in, Mylan can afford to sell epipens below cost until the new company has to fold due to losses.
And with high capital costs, that means a big loss.
So it's not profitable for others to push in, as the moment they push in, the price differential will disappear, and the new guy won't make any money, and spent a lot on capital.
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On August 28 2016 10:01 xDaunt wrote:Show nested quote +On August 28 2016 09:59 TheTenthDoc wrote:On August 28 2016 09:41 xDaunt wrote:
The FDA is one of the biggest reasons why drugs and treatments are so expensive. The regulatory approval process is absurd. And to make matters worse, companies spend millions lobbying the hell out of the FDA to delay or deny competitors approval of their new products, all of which just further drives up health care costs. FDA is also the only reason drugs and treatments actually work and aren't contaminated with rat droppings. There's a reason we had that huge meningitis outbreak-the injections were from non-FDA regulated pharmaceutical compounding. So it's kind of a tough situation to deal with (it doesn't help that their hands are tied with respect to things they need to be able to do and untied with respect to things they really shouldn't be doing). Have you ever looked at the differences between the FDA regulatory process and what you'll find in the EU?
Are you talking EU-wide licensing, individual nation licensing, or both (not everywhere is bound by EMA as far as I know)? Are you talking safety or efficacy?
If we're talking manufacturing safety, the EU has another agent entirely that's responsible for that at the overall level (if they have one at all), I think, so just looking at EMA isn't appropriate.
I happen to think the FDA having a management role in clinical trials and bioequivalence is absolutely necessary, mostly because I've seen how much people fucked up in their clinical trials and bioequivalence testing even alongside that management role and how little they themselves understand (or present themselves as understanding) the public health consequences of their research.
+ Show Spoiler +As a side-note I spent six weeks interning at FDA and went to multiple advisory committee meetings. I also have a degree in pharmacy. So take that as you will with respect to bias on this issue.
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On August 28 2016 10:10 TheTenthDoc wrote:Show nested quote +On August 28 2016 10:01 xDaunt wrote:On August 28 2016 09:59 TheTenthDoc wrote:On August 28 2016 09:41 xDaunt wrote:
The FDA is one of the biggest reasons why drugs and treatments are so expensive. The regulatory approval process is absurd. And to make matters worse, companies spend millions lobbying the hell out of the FDA to delay or deny competitors approval of their new products, all of which just further drives up health care costs. FDA is also the only reason drugs and treatments actually work and aren't contaminated with rat droppings. There's a reason we had that huge meningitis outbreak-the injections were from non-FDA regulated pharmaceutical compounding. So it's kind of a tough situation to deal with (it doesn't help that their hands are tied with respect to things they need to be able to do and untied with respect to things they really shouldn't be doing). Have you ever looked at the differences between the FDA regulatory process and what you'll find in the EU? Are you talking EU-wide licensing, individual nation licensing, or both (not everywhere is bound by EMA as far as I know)? Are you talking safety or efficacy? If we're talking manufacturing safety, the EU has another agent entirely that's responsible for that at the overall level (if they have one at all), I think, so just looking at EMA isn't appropriate. I happen to think the FDA having a management role in clinical trials and bioequivalence is absolutely necessary, mostly because I've seen how much people fucked up in their clinical trials and bioequivalence testing even alongside that management role and how little they themselves understand (or present themselves as understanding) the public health consequences of their research. + Show Spoiler +As a side-note I spent six weeks interning at FDA and went to multiple advisory committee meetings. I also have a degree in pharmacy. So take that as you will with respect to bias on this issue.
For drugs, I was referring to the EMA.
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On August 28 2016 10:08 zlefin wrote:Show nested quote +On August 28 2016 09:58 xDaunt wrote:On August 28 2016 09:49 OuchyDathurts wrote:There was a reddit AMA with a pharma CEO that touched on this the other day.
What stops a company like your from undercutting another company says Mylan for instance, by flooding the market with a cheaper variant of their epipen auto injectors?First of all Mylan is primarily a generic company and they understand as well as anyone how the generic market works. There is nothing other than technology, intellectual property and manufacturing capability to stop someone from coming up with a cheaper version. In the generic market, having a portfolio of generic products allows large generic companies to have the ability to price below cost on certain SKUs and therefore a small company with only one generic is vulnerable to losing market share and therefore profits. www.reddit.com Product price clearly isn't the barrier to entry in this instance given how high the mark up is. you're missing the point daunt; the point is that if another company tries to butt in, Mylan can afford to sell epipens below cost until the new company has to fold due to losses. And with high capital costs, that means a big loss. So it's not profitable for others to push in, as the moment they push in, the price differential will disappear, and the new guy won't make any money, and spent a lot on capital.
It doesn't have to be a small new company. It can be (and usually is) a big existing generic manufacturer with the capacity to absorb the risk. There is a large capital cost involved and the fact that Mylan can drop its prices at any time and undercut the investment is a problem, but other new generics get created regularly despite this. There's something slightly unusual about this case.
From about 3 minutes' worth of googling it seems like the main problem is that there were competitors in the works, but their products all fell over for various individual reasons, some at the FDA approval stage. Mylan then found itself temporarily alone in a niche, and capitalised by hiking its prices.
Not sure what the solution is. The system seems to work okay so long as there are at least a few companies involved in each field, so maybe something to encourage that. It also sounds like the FDA process creates a costly lag time that could be reduced. One thing that I've always found insane is how little the major agencies like the FDA and EMA communicate with each other, since that would speed things up enormously.
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On August 28 2016 10:08 zlefin wrote:Show nested quote +On August 28 2016 09:58 xDaunt wrote:On August 28 2016 09:49 OuchyDathurts wrote:There was a reddit AMA with a pharma CEO that touched on this the other day.
What stops a company like your from undercutting another company says Mylan for instance, by flooding the market with a cheaper variant of their epipen auto injectors?First of all Mylan is primarily a generic company and they understand as well as anyone how the generic market works. There is nothing other than technology, intellectual property and manufacturing capability to stop someone from coming up with a cheaper version. In the generic market, having a portfolio of generic products allows large generic companies to have the ability to price below cost on certain SKUs and therefore a small company with only one generic is vulnerable to losing market share and therefore profits. www.reddit.com Product price clearly isn't the barrier to entry in this instance given how high the mark up is. you're missing the point daunt; the point is that if another company tries to butt in, Mylan can afford to sell epipens below cost until the new company has to fold due to losses. And with high capital costs, that means a big loss. So it's not profitable for others to push in, as the moment they push in, the price differential will disappear, and the new guy won't make any money, and spent a lot on capital.
It's expensive to drive your competitors to fold through predatory pricing, I would be surprised if it's actually worth it. Ideally they would just threaten to do it and keep competitors out that way, but I really don't know if it would be credible. Besides, though I don't know the specifics of the US, there is probably legilation against predatory pricing.
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On August 28 2016 10:56 Belisarius wrote:Show nested quote +On August 28 2016 10:08 zlefin wrote:On August 28 2016 09:58 xDaunt wrote:On August 28 2016 09:49 OuchyDathurts wrote:There was a reddit AMA with a pharma CEO that touched on this the other day.
What stops a company like your from undercutting another company says Mylan for instance, by flooding the market with a cheaper variant of their epipen auto injectors?First of all Mylan is primarily a generic company and they understand as well as anyone how the generic market works. There is nothing other than technology, intellectual property and manufacturing capability to stop someone from coming up with a cheaper version. In the generic market, having a portfolio of generic products allows large generic companies to have the ability to price below cost on certain SKUs and therefore a small company with only one generic is vulnerable to losing market share and therefore profits. www.reddit.com Product price clearly isn't the barrier to entry in this instance given how high the mark up is. you're missing the point daunt; the point is that if another company tries to butt in, Mylan can afford to sell epipens below cost until the new company has to fold due to losses. And with high capital costs, that means a big loss. So it's not profitable for others to push in, as the moment they push in, the price differential will disappear, and the new guy won't make any money, and spent a lot on capital. It doesn't have to be a risky new company. It can be a big existing generic manufacturer that just starts a new line. There is a large capital cost involved and the fact that Mylan can drop its prices at any time and undercut their investment is a problem, but new generics get created all the time. There's something slightly unnusual about this case to have created this situation. From about 3 minutes' worth of googling it seems like the main problem is that there were competitors in the works, but their products all fell over for various individual reasons, some of which was due to the FDA. Consequently Mylan found itself alone in a niche and capitalised by hiking its prices, which would be perfectly fine in any field other than health. Not sure what the solution is. It sounds like the FDA process is a pretty big hurdle that could be lowered. One thing that I've always found insane is how little the major agencies like the FDA and EMA communicate with each other, since that would speed things up enormously.
FDA did just manage to obtain funding for a huge expansion of their generics division in 2015, making abbreviated new drug application turnaround times substantially lower. We won't see those effects ripple through to the market as a whole in positive ways for a bit, though.
The problem is that more people often means more eyes finding small mistakes that are just barely sufficient to drop something below the bar.
And, since EMA and FDA don't quite have the same responsibilities with respect to manufacturing (some loose google-fu showed that EMA delegates to national certification, kinda like if we had state authorization of manufacturers) oftentimes things will go through for approval but be held up by manufacturing issues.
Also, generally there is some sharing (especially if a drug gets approved in the EU/Japan the company will often share the documentation with FDA if allowable). But I believe EMA's standard for approval isn't quite the same as FDA's for brand new drugs (generally two RCTs with pre-specified endpoints with p value < 0.05) but that's one of my my problems with the FDA's system so.
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United Kingdom13775 Posts
On August 28 2016 10:56 Belisarius wrote:
From about 3 minutes' worth of googling it seems like the main problem is that there were competitors in the works, but their products all fell over for various individual reasons, some at the FDA approval stage. Mylan then found itself temporarily alone in a niche, and capitalised by hiking its prices.
And therein lies the problem. Financially, it makes sense to do that. From a public health perspective, free market financial incentives lead to people who need medicine getting fucked by high prices. That's the issue here.
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On August 28 2016 03:11 {CC}StealthBlue wrote:Might be a little late I think. Show nested quote +Anti-Trump Republicans are preparing to launch a broadcast TV ad in a handful of swing-state suburbs urging Donald Trump to quit the presidential race so the party can replace him with a more electable nominee.
The ad, titled "Keep Your Word," features footage of Trump during the Republican primary in which he suggested he'd drop out if he saw his poll numbers decline.
"Number one, I'm not a masochist, and if I was dropping in the polls where I saw I wasn't going to win, why would I continue?" Trump said in an October NBC interview featured in the ad. A graphic displaying political handicappers' predictions of a landslide Trump loss accompanies his remarks. The ad ends with a plea: "Resign the nomination. Let the RNC replace you so we can beat Hillary."
The 30-second spot is marked for a limited run on broadcast networks in suburban Florida, Virginia, Ohio and Michigan, according to Regina Thomson, a Colorado Republican activist and leader of Free the Delegates, the organization that failed to stop Trump's nomination at last month's national convention. All four states are central to Trump's path to the White House, though he's trailing in most polls of those states.
The ad is backed by a five-figure buy, according to Thomson, but the group is hopeful to eventually expand its run to Fox News Channel. It's initially set to air on broadcast news channels beginning on Tuesday. It's marked for the four states' suburban media markets, according to Free the Delegates, because they're areas that typically lean Republican but appear to be tilting in Hillary Clinton's favor this year. Source
If Trump dropped out today, the next nominee would have more time to campaign than candidates in other democracies get to for the entire allotted campaign time.
The monstrous length of the American democratic/republican nomination system might have skewed some people's perspectives.
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On August 28 2016 10:56 Belisarius wrote:Show nested quote +On August 28 2016 10:08 zlefin wrote:On August 28 2016 09:58 xDaunt wrote:On August 28 2016 09:49 OuchyDathurts wrote:There was a reddit AMA with a pharma CEO that touched on this the other day.
What stops a company like your from undercutting another company says Mylan for instance, by flooding the market with a cheaper variant of their epipen auto injectors?First of all Mylan is primarily a generic company and they understand as well as anyone how the generic market works. There is nothing other than technology, intellectual property and manufacturing capability to stop someone from coming up with a cheaper version. In the generic market, having a portfolio of generic products allows large generic companies to have the ability to price below cost on certain SKUs and therefore a small company with only one generic is vulnerable to losing market share and therefore profits. www.reddit.com Product price clearly isn't the barrier to entry in this instance given how high the mark up is. you're missing the point daunt; the point is that if another company tries to butt in, Mylan can afford to sell epipens below cost until the new company has to fold due to losses. And with high capital costs, that means a big loss. So it's not profitable for others to push in, as the moment they push in, the price differential will disappear, and the new guy won't make any money, and spent a lot on capital. It doesn't have to be a small new company. It can be (and usually is) a big existing generic manufacturer with the capacity to absorb the risk. There is a large capital cost involved and the fact that Mylan can drop its prices at any time and undercut the investment is a problem, but other new generics get created regularly despite this. There's something slightly unusual about this case. From about 3 minutes' worth of googling it seems like the main problem is that there were competitors in the works, but their products all fell over for various individual reasons, some at the FDA approval stage. Mylan then found itself temporarily alone in a niche, and capitalised by hiking its prices. Not sure what the solution is. The system seems to work okay so long as there are at least a few companies involved in each field, so maybe something to encourage that. It also sounds like the FDA process creates a costly lag time that could be reduced. One thing that I've always found insane is how little the major agencies like the FDA and EMA communicate with each other, since that would speed things up enormously.
Most large companies are in a web of cold war counter lawsuits just waiting to happen. A kind of "we won't bring up X if you don't do Y" except they have that with 10 other companies, and 10 other companies have that with them. This creates weird stalemates among big companies where neither side goes for anything, and when one actually does, a whole bunch goes bankrupt in the process.
Not a bad thing per se, but its an issue with how large companies interact with each other.
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