The FDA won't approve any of them†. There are a number of alternatives in Europe, but they can't legally sell them in the US (except for one and it's under some silly restrictions that keep it from being used more widely.)
†Or sets the cost of approval to be vastly higher than any potential profits, which is effectively the same thing.
It takes quite a long time and a significant amount of money to perform the necessary studies and get the FDA approval. The time factor alone makes it difficult for a competitor to react efficiently if the main or sole provider for a drug or device increases prices drastically.
Mylan reportedly also used a few more anti-competitive tactics like contracts with schools that lower the price for them, but prohibit the school from buying any competing products (see e.g. http://www.reuters.com/article/us-mylan-new-york/new-york-to... )
The strict FDA requirements are there to make sure only safe and effective products come onto the market. That's a good thing. What's bad is that some can use this system to their advantage to create artificial monopolies.
If you're the only maker of a drug, and even if it's not covered by any patents, you know it'll still take months or perhaps years for a competitor to get FDA approval and compete with you. You can jack up your prices until competitors go through the approval, and you can signal to the market that you will quickly drop the prices if another competitor comes onto the market. This discourages the competitors from even spending the time and money on FDA approval.
Two possible solution to this: (1) reduce the cost of FDA approval for companies that want to make generic copies; or (2) impose taxes or price caps on FDA products that have no competition and command market power.
This all assumes patents are not involved (as is the case here), but both solutions would reduce the intensive for companies to game a system that is intended to make sure only safe products make it onto the market.
It's about the drug delivery device (i.e. the "pen"), and the failure of Pfizer/Meridian (the contract manufacturer of the device) to follow correct design and manufacturing practices.
They don't have a proper CAPA system in place, they don't have proper design control or procedures, the DHFs are missing up to date inputs, risk analysis isn't up to date, etc.
It's pretty damning, but it's not about the pharma aspect of this. Basically the manufacturer lacks a functional quality system, which is table stakes for this stuff.
I would guess because once approved, the FDA has a much more limited role. I believe they can force a recall though. Technically the problem was mechanical, not pharmaceutical. I'm not sure if that had anything to do with it though.
I myself am kinda glad it is not easy to put a medication to market. However, big pharma is quite proficient at dealing with regulatory bodies already since they have so many products on the market, so I don't think that's tthe main reason
Probably payouts from the current manufacturer to stay out of the market. Those payoffs are probably greater than the profit they could make as an off-brand generic.
Requiring financial transparency among all possible parties to regulators and banning collusion like the above would actually be the correct way to ensure the market functions properly.
What everyone else said, but also there's something around pharmacists have to fill the prescription as it's written, and cannot substitute generics.
So, if a dr writes "epipen" it needs to be an actual Epipn(TM) that gets handed over.
There's a UI aspect here too. Doctors use software, and if that software presents expensive non-generics first in the drop-down list that's the med that gets selected.
That's not correct. If a brand name is listed, a generic can (and usually is) substituted. They (the pharmacists) only don't if "DAW" (Dispense As Written) is written as well.
Here is a state-by-state guide on how to write a prescription to ensure the brand name drug is not substituted.[1]
This is all not relevant though, as EpiPen is not considered to have a (non-Mylan) generic equivalent available.
The FDA. Or at least, the FDA has made it extremely expensive and time-consuming for any competitor who wishes to enter the market.
The argument is that a high bar of safety requirements protects consumers (and I'll admit it does to some degree, however inefficiently), but a free market system is more efficient at producing the results that people actually care about (quality, safety, affordability, etc).
Also, patents - another government-run monopoly-maker that should be eliminated.
a free market system is more efficient at producing the results that people actually care about (quality, safety, affordability, etc)
You have no evidence to support that view; where are the free markets full of safe, high-quality, low-cost medicines? Nowhere.
Markets are brilliant, but they are not flawless. All of our experience suggests that they need robust, independent regulation to avoid negative outcomes. There is plenty of scope for talking about how time-to-market for drugs can be improved, or other steps that can be taken to reduce regulatory burden where it's causing problems. But this whole 'let the free market sort it out' is the worst kind of high-school libertarianism.
We haven't had free markets for a very, very long time. Consequently, your claim of free markets unavoidably producing negative outcomes lacks evidence.
I didn't say we don't need any regulation, but I will say that government-imposed regulation isn't needed. A truly free market can and will fill that same need in ways that are much more efficient than any government could hope to do through force.
We haven't had free markets for a very, very long time. Consequently, your claim of free markets unavoidably producing negative outcomes lacks evidence.
This is basically a "no true Scotsman" argument. What is a "free market"?
I didn't say we don't need any regulation, but I will say that government-imposed regulation isn't needed.
Non-authority-imposed regulation isn't 'regulation' in any real sense.
A truly free market can and will fill that same need in ways that are much more efficient than any government could hope to do through force.*
All evidence we have seen suggests that an absence of government regulation leads to collusion, anticompetitive practices, races-to-the-bottom, and consumer rights violations. On the other hand, removing regulation can allow more innovative approaches to the market. Point is – it's a case of fine-tuning the balance to make sure that participants in a market have equal power. "Throw is all away and start again" is a seductive and ultimately silly argument.
>Non-authority-imposed regulation isn't 'regulation' in any real sense.
How exactly isn't it "real"? Even in the absence of a truly free market, plenty of industries have developed their own self-regulated quality standards.
Have you ever checked reviews about something before purchasing? Did a government mandate those reviews to be written?
> an absence of government regulation leads to collusion, anticompetitive practices, races-to-the-bottom, and consumer rights violations
Isn't it odd that we see more of those problems in industries with the most regulation? In a free market, collusion is ineffective, since any newcomer can undercut prices, forcing the colluding market players to compete. The same could be said for any other unethical or harmful practices; if consumers care enough about a problem, they'll vote with their dollars for better alternatives.
"We haven't had free markets for a very, very long time. Consequently, your claim of free markets unavoidably producing negative outcomes lacks evidence."
You could easily replace "free markets" with "communism" and make the same statement.
FDA is the golden standard for medical testing for around the world (I worked for the FDA and that quote I'll quote one of the employee that stated it). After animal testing there are 4 phases of clinical testing.
You sound like all those libertarians that think free market is gonna some how reduce toxicity and dangerous drug from flooding the market.
That's some crazy pipe dream you got there.
These testing is also base on science and more importantly statistic (survival analysis and such). It is stupid as hell to just ignore it. Statistic is every where in lives and have increase the quality of our life including reliability and quantifying on what is statistic significant or not (random chance).
You are a perfect example of why I'm sick of debating libertarian and just straight up call it out.
Free Market is another excuse for ignorant. Whether it is ignorance of how the FDA and drug works to how the economy work (let's back everythign by the gold standard!).
The FDA's approval process is to ensure only safe and effective products make it to the market. This is unquestionably good. The problem is that companies can take advantage of the inherent delays in this process to obtain undue market power, and impose monopoly pricing.
The FDA should not reduce it's standards, but it should recognize that the expensive and drawn-out approval process creates large inefficiencies in that market, and they should at least strive to minimize those effects.
I don't buy the regulatory argument. See my previous answers.
Patents, indeed, are a much more efficient way of keeping a monopoly, that's their whole point after all. But I don't a link with regulations in that case.
