Everything You Need to Know about the EpiPen Controversy

Epipen

Article by Jillian Barton

Mylan, the company that makes the allergy auto-injection device EpiPen, continues to be at the center of a heated national controversy after increasing the price of their life-saving drug from $100 to $600 for a two-pack.

EpiPens are a medical emergency device that contain a dose of epinephrine, also commonly known as adrenaline. They are used in emergency situations for severe anaphylactic, or allergic, reactions. Anaphylaxis can occur quickly – in a matter of minutes after being exposed to an allergen.

Common allergens that result in anaphylaxis include food, insect or bee stings, and medications.The dose of epinephrine that an EpiPen injects into the body constricts the blood vessels, which results in an increase in blood pressure. It also relaxes the smooth muscle in the lungs, which improves breathing, increases heart rate and reduces swelling around the lips. All of these remedies can be crucial to saving the life of the person who is having a severe reaction.

Epipen
Image Credit: Phillip Bradshaw

But EpiPens have a short shelf-life, further contributing to the outrage about the recent price hike. Currently, the shelf-life for EpiPens is 18 months. However, once the device reaches consumers, it is more likely to expire within a year.

Because of the potential severity of allergic reactions, doctors encourage patients to carry EpiPens on them at all times – in work, school, and in the car. Doctors also stress not using an expired EpiPen because the chemicals are less likely to give the desired strength of a fresh dosage of adrenaline. If an EpiPen is exposed to light, heat, or air, the chemicals inside can degrade and become less effective.

Due to their short shelf-life and necessity, people in dire need of Epipens annually dispose of them and purchase new ones. This has been central to the national outcry about people being unable to afford multiple EpiPens at such a high cost.

In response to consumers’ indignation, Mylan promised to unveil a generic version of the EpiPen that would be more reasonably priced for those who are struggling to afford it. The generic drug is expected to cost $300. This generic product would have the same active ingredient, strength, and dosage as the brand drug, but not have the EpiPen name attached. FDA regulations require generic drugs to have the same effect in the body as the name brand drug.

Epipen
House dust mites (Dermatophagoides pteronyssinus), a common allergen, aggregate. Image Credit: Gilles San Martin

Despite these attempts at appeasing consumers, Mylan is still being criticized by many. It is suspected that Mylan incorrectly classified the EpiPen as a “generic drug”, when it should have been classified as  an “innovator drug”, because it currently doesn’t have any FDA-approved competitors. This classification has allowed the company to pay a lower percentage in rebates to state Medicaid programs, effectively scamming the government and consumers.

However, Mylan CEO Heather Bresch claims that Epipens have been classified as generic drugs since the company acquired the drug back in 2007.  Bresch has been particularly subjected to harsh censure for the colossal price hike in EpiPens. Bresch made $18 million last year–a salary that many see as reflecting the greed that enabled the drug to be withheld from so many people who are in need of it.

On Friday, the company disclosed that the Securities and Exchange Committee has launched an investigation into the company. Mylan also revealed that the company agreed to a $465 million settlement with the Justice Department on Friday, which may be construed as an admission of guilt. The settlement has not been finalized yet.

 

 

Feature Image: Mylan CEO, Heather Bresch. Federal Trade Commission Chairman Jon Leibowitz discussed recent developments on the issue of pay to delay settlements. A panel of distinguished experts also talked about generic drug competition and a report issued by CAP on competition in the pharmaceutical markets. Image Credit :Ralph Alswang

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