EpiPen prices are out of control! Here’s how we fix the problem

"We're from the government and we're here to help," has become a punchline without need of a set up. But the laughs turn quickly to anger when we keep hearing about how government rules that don't hold up under scrutiny are actually hurting a lot of people. And that anger is reaching a crescendo this week as outrage grows over the soaring cost of Mylan's EpiPen, a life-saving device for children and others with severe allergies.

The price has jumped from about $100 for a two-pack in 2008 to $400 or more today. And, they tend to expire after a year, so you have to replace them every year.

Even Martin Shkreli, who became the poster boy for jacking up drug prices, called Mylan executives "vultures" for the price hike.

I have two daughters with nut allergies myself, and I can tell you that going without an EpiPen is simply not an option for them. But instead of asking the government to come in and provide more help, the solution to this problem is simply to demand that the government start doing a lot less.

It's important to understand exactly what people are paying for when they buy the EpiPen. The cost of the life-saving epinephrine drug itself is minimal. Epinephrine has been around for more than 100 years and is easy to produce. The real costs come in connection to the EpiPen's auto-injector which delivers the drug to people who need it in a much easier fashion than a traditional needle and syringe. Mylan's patent on that auto-injector is the key to everything. And it's the government's protection of that patent that lies at the root of the price hikes that are leaving a lot of families struggling to meet the costs.

Simply put, the government is providing Mylan with a great deal of price protection in two key ways. The first is the high standard the Food and Drug Administration imposes on any competing auto-injectors. The second is the continued knee-jerk rule that makes almost all drugs in the United States available by prescription only.

Let's start with the high standards. Sanofi found this out the hard way last year when it felt pressure to issue a recall on all of its 2.8 million Auvi-Q epinephrine auto-injectors in North America. In its recall announcement, the FDA stated that Auvi-Q: "products have been found to potentially have inaccurate dosage delivery, which may include failure to deliver the drug."

Here's the problem: The same is true for Mylan's EpiPen. The number of reported device failures for Auvi-Q wasn't significantly different from the EpiPen failure numbers. And study after study shows that most people who use epinephrine auto-injectors in real-life situations do not use them properly. Ganging up on Sanofi's product seems a lot more dubious in retrospect. The bottom line is that epinephrine auto-injectors provide the most help to those responsible enough to learn exactly how to use them, (many of drug packs include tester kits to practice with), and those people should not be faced with higher prices and other barriers. But that's exactly what happened. Auvi-Q's exit from the market provided Mylan much more room to increase prices, and it's done just that. There is no solid evidence that the FDA was deliberately giving unfair favoritism to Mylan, but EpiPen does seem to be enjoying special treatment.

But even if you want to argue that Mylan's auto-injector product really is safer than any competitor so far, there's still a major problem connected with the prescription requirement. And that problem is that the government's supposed inclination to protect the public defies fairness and mathematics.

Similar to the longer-standing, but just-as-heated battle in this country over birth-control medications, it's clear that a tremendous amount of the cost and other access problems connected to epinephrine auto-injectors could easily be solved simply by making them over the counter.

"Even Martin Shkreli, who became the poster boy for jacking up drug prices, called Mylan executives 'vultures' for the price hike."

"But wait!" you cry … isn't the government doing the right thing by protecting an irresponsible public from being able to easily buy epinephrine injectors and abusing them? The simple answer to that is: Abusing them how, exactly? And how many people out there are abusing them? Don't get me wrong, I'm sure we could find a few dozen drug-abuse obsessed people in this country who can and will find a way to abuse their EpiPens. But should the government be acting more aggressively to stop these obviously self-destructive people or should it be concentrating on doing what it can to help the millions of people who are trying to be personally responsible and stay alive? That's the choice, after all.

And with that in mind, just who is the government protecting by keeping epinephrine auto-injectors by prescription only? It's obscene and scary that responsible people who want to protect their health have to pay more and go through the tedious and sometimes expensive process of getting a prescription in order to protect those who want to abuse their health and might … just might … choose to use their life-saving drug or device to abuse it.

Over the counter or not, there will still be costs connected to reasonable testing of the auto-injector by government regulators. No one is arguing against that. And the FDA still regulates over-the-counter drugs in many other ways. But OTC medicines put a lot more responsibility into the hands of the actual people who use them. Pharmacists will also need to become more educated about advising customers on the injectors' proper use and maintenance.

In other words, don't expect a shift to OTC to translate to auto-injectors going for $5 a pop. But the days of out-of-control price increases on a life-saving drug will indeed end once we get the government and many of its dubious regulations out of the equation.

Commentary by Jake Novak, supervising producer of "Power Lunch." Follow him on Twitter @jakejakeny.

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