The EpiPen is the latest drug facing drug-pricing pressure in the US. Australians are worried about the potential impact here, too.
But it wasn’t always this way.
The injectable delivers a dose of epinephrine, otherwise known as adrenaline, to treat extreme allergic reactions. It’s been around for more than a century. And the pen that delivers the medication has been around since the 1970s, when it was first developed for the military.
Since 2007, the price for a two-pack has gone up from $93.88 to $608.61, an increase of more than 500%.
Here’s the story of how a device that’s now a household name became one of the most controversial drugs of 2016.
Epinephrine, another name for the hormone adrenaline, is something our bodies produce naturally. It increases blood flow to the muscles during 'fight or flight responses.'
Japanese chemist Jokichi Takamine is credited as one of the first people to discover and isolate adrenaline as its own chemical. Not long after its discovery, scientists figured out how to produce it in large enough quantities to see how it could be used in different medical settings.
Doctors continued to investigate how adrenaline works during the early part of the 20th century. In the past 100 years, it's been extensively studied, with more than 12,000 studies referencing it.
The study of epinephrine jump-started other areas of emergency medication for heart and lung problems. The hormone is now used in hospitals around the world, and is included on the WHO's list of essential medicine. It only costs a few dollars for a vial.
In the 1970s, Sheldon Kaplan, a biomechanical engineer, unknowingly invented the ultimate way to self-inject epinephrine. At first, his device, called the ComboPen, was used by the military to protect soldiers in the event of chemical warfare. The military needed a device that wouldn't react with the drug inside, and that could be easy to use in emergency situations.
Meridian Medical is now a subsidiary of Pfizer, where it still makes a host of other auto-injector devices -- including an anti-nerve-gas pen still in use by the military.
When Mylan acquired the EpiPen, the drug was making about $200 million a year. Now, it makes more than $1.1 billion a year. Mylan has about 90% of the market share for epinephrine devices.
Other devices do exist, but none has been able to grab much of the market from the EpiPen. Among them was a device called Twinject that was first approved in 2003 and then was later updated to become Adrenaclick. Another device, the Auvi-Q, was first approved in 2012.
Auvi-Q has been recalled since last October, and the company that was marketing the product has since returned the rights. The device doesn't seem to have a timeline specifying when it will be back in the US, if ever.
Among those steps to making the EpiPen a billion-dollar drug, President Barack Obama signed legislation in 2013 that helped public schools build up emergency supplies of EpiPens.
'There was very, very little awareness,' Bresch said Thursday in an interview with CNBC. 'We took on -- we have doubled the lives of patients that are carrying an EpiPen. We have passed legislation in 48 states to allow undesignated EpiPens to be in schools.'
Mylan has also pushed out marketing to promote awareness for anaphylaxis, a severe allergic reaction that can make people go into shock, struggle to breathe, or get a skin rash. Most recently, they have run a 'Face Your Risk' campaign, including an ultra-realistic commercial about someone having an extreme allergic reaction to peanut butter brownies.
In August, members of Congress, along with Democratic presidential nominee Hillary Clinton called out Mylan for the EpiPen's high price.
In response, Mylan announced a change in the company's copay coupon system, more than doubling the available discount for a two-pack to $300. But that did little to quell the tempers of those in Congress, who still wanted to see a cut to the company's list price.
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