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August 25 2016

Blame Washington for EpiPen Shock

Patrice L. Onwuka

Parents and patients are in shock over the 400 percent spike in prices for a life-saving medicine. Not surprisingly, Washington is aghast, but while they are wagging their fingers at the drug maker Mylan, they should look at the other fingers pointing back at them.

Pharmaceutical giant Mylan produces the EpiPen which helps a person inject epinephrine (adrenaline) when they have a life-threatening reaction to a food or get stung by an insect. It’s packaged in an easy-to-carry pen that many moms and dads can slip in their children’s book bag or an adult can carry in a purse. With the back-to-school season in full swing parents are the one with anaphylactic shock over the prices of EpiPen, which went from about $57 to over $600 in just nine years. That’s especially unbelievable given the medicine only costs cents.

The pen has been around since the 1970s, but Mylan enjoys 98-percent market share, because there are virtually no competitors. Headlines point to price gouging, but there is little competition. There’s only one generic competitor, but it has availability problems. It didn’t win FDA approval this year, so we’ll have to wait until next year at least.

Former Secretary of State Hillary Clinton even jumped on the bandwagon demanding that the company reduce its prices immediately and predictably calling for more Washington regulation over drugs because of the monopoly that Mylan has.

Mylan is far from innocent here, but big government is precisely the culprit, along with Mylan, in creating an environment where (1) there’s no competition or choice and (2) there’s a massive market looking to EpiPen as the preferred choice.

First, the FDA has failed to approve generic devices that could drive the prices down, while still providing a safe, quality product as the Wall Street Journal explains:

But no company has been able to do so to the FDA’s satisfaction. Last year Sanofi SNY -0.97 % withdrew an EpiPen rival called Auvi-Q that was introduced in 2013, after merely 26 cases in which the device malfunctioned and delivered an inaccurate dose. Though the recall was voluntary and the FDA process is not transparent, such extraordinary actions are never done without agency involvement. This suggests a regulatory motive other than patient safety.

Then in February the FDA rejected Teva’s generic EpiPen application. In June the FDA required a San Diego-based company called Adamis to expand patient trials and reliability studies for still another auto-injector rival.

Second and most egregious, this situation ensued because of a series of maneuvers with Congress, the FDA, and even President Obama that expanded the number of consumers the product could be marketed to as well as federal legislation that put EpiPens in schools across the country with financial incentives to sweeten the deal.

In 2008, the FDA allowed EpiPens to be marketed to those who had a risk of anaphylactic reaction rather than just for those who had a proven response to allergens. That allowed for campaigns to push the narrative among millions of families that the pen was needed in their home as a precaution and actresses, like Sarah Jessica Parker, serving as the face.

Meanwhile, Congress and President Obama spent the past few years getting EpiPen into schools through what was meant to be a good measure, but had the unintended consequence of benefitting the only maker of the drug, Mylan. Gizmodo explains:

In 2013, President Obama signed the School Access to Emergency Epinephrine Act. It was that rare piece of legislation that both Democrats and Republicans agreed upon (Klobuchar was a co-sponsor of the legislation). “This is something that will save children’s lives,” Obama said.

The law did two things: It essentially protected anyone at public schools from any damage, provided they injected students with EpiPens in good faith. Which is to say, it was basically a Good Samaritan law for allergy-specific situations. Previously, first responders and public school nurses were the only people allowed to inject children with epinephrine if they were having an allergic reaction. And in the case of the school nurse, it was almost always the case that they could only inject the child if the EpiPen belonged to the child. The new legislation encouraged the stocking of EpiPen reserves, and made those reserves communal.

“Some people may know that Malia actually has a peanut allergy,” President Obama said at the time about his daughter. “She doesn’t have asthma, but obviously making sure that EpiPens are available in case of emergency in schools is something that every parent can understand.”

While members of Congress and politicians are coming out of the woodwork to decry “price gouging” by Mylan, they should first take a step back to see how their actions – even if well-intentioned – played a major role in causing the situation. That the FDA has yet to approve an alternative is just another way Washington has chosen one big winner.

Something needs to be done, but it starts with Washington fixing the problems it created.

 

IIndependent Women's Forum is an educational 501(c)(3) dedicated to developing and advancing policies that aren’t just well intended, but actually enhance people’s freedom, choices, and opportunities. IWF is the sister organization of the Independent Women’s Voice.​
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