Mylan’s EpiPen and EpiPen Jr. are intended to treat sudden and life-threatening allergic reactions resulting in anaphylaxis. Malfunctions have been associated with hospitalizations and deaths even as EpiPen’s price skyrocketed.
EpiPens are auto-injector devices, pre-loaded with medication and intended to treat severe allergic or asthmatic emergencies. People can remove a safety cap and slam the device against their thigh, causing the EpiPen to deploy a needle into skin or muscle. The action should trigger delivery of a precise dose of epinephrine (also called adrenaline). This can head off anaphylaxis – a life-threatening allergic reaction.
|0.3 mg epinephrine||Intended for patients weighing 66 pounds or more|
|0.15 mg epinephrine||Intended for patients weighing 33 to 66 pounds|
Pfizer subsidiary Meridian Medical Technologies manufactures the devices for another drug company, Mylan N.V. The companies also manufacture and market the only generic version of the EpiPen.
In 2016, Mylan raised EpiPen prices by 400 percent, drawing sharp criticism. The following year, the company announced Meridian had recalled 13 lots of defective EpiPens after reports of life-threatening malfunctions.
Anaphylaxis happens when a person’s immune system overreacts to an allergen. The most dangerous symptoms include a sudden drop in blood pressure, breathing difficulty and passing out. It requires immediate medical attention.
EpiPens are intended to stave off the symptoms long enough for a patient to get to seek medical attention. Even though an EpiPen may relieve the symptoms temporarily, the effect may only last 15 minutes. People prescribed EpiPens are advised to have a second one available in case the effects wear off before they can seek medical help.
EpiPen’s label includes a warning that people should always seek “immediate medical or hospital care” whenever they use the device.
In 2017, Bloomberg reported that EpiPen failures had been associated with seven deaths through mid-September of that year. Reports from the same period showed another 228 people were hospitalized after their EpiPen or EpiPen Jr. failed. The FDA Adverse Events Reporting System (FAERS) Public Dashboard shows reports of EpiPen complications more than doubled between 2016 and 2017.
The FDA points out that reports in its database do not confirm medical products are the actual cause of a complication or death. However, the reports show only a fraction of the complications believed to have occurred since so few people know they can file a report with the agency when they experience a problem.
In March 2017, Meridian recalled 80,000 EpiPens sold around the world. A week after the initial recall, Mylan announced Meridian had recalled thousands more EpiPens distributed in the U.S. The recalls were announced after reports that a defective part could cause them to malfunction.
In the U.S., 13 lots of EpiPen and EpiPen Jr. devices were included in the recall. All had been distributed between December 2016 and July 2017. The expiration dates on the affected devices ranged from April to October 2017.
|Product & Dosage||Lot Number||Expiration Date|
|EpiPen Jr., 0.15 mg||5GN767||April 2017|
|EpiPen Jr., 0.15 mg||5GN773||April 2017|
|EpiPen Jr., 0.15 mg||6GN215||September 2017|
|EpiPen, 0.3 mg||5GM631||April 2017|
|EpiPen, 0.3 mg||5GM640||May 2017|
|EpiPen, 0.3 mg||6GM082||September 2017|
|EpiPen, 0.3 mg||6GM072||September 2017|
|EpiPen, 0.3 mg||6GM081||September 2017|
|EpiPen, 0.3 mg||6GM088||October 2017|
|EpiPen, 0.3 mg||6GM199||October 2017|
|EpiPen, 0.3 mg||6GM091||October 2017|
|EpiPen, 0.3 mg||6GM198||October 2017|
|EpiPen, 0.3 mg||6GM087||October 2017|
In a press release announcing Mylan’s recall, the FDA reminded people to always seek emergency treatment after using an EpiPen, “particularly if the device did not activate.”
The agency also called on consumers and health care professionals to report any EpiPen malfunctions or complications from the devices to its MedWatch program.
In September 2017, the FDA sent Meridian a warning letter citing the company for failing to appropriately investigate hundreds of complaints of EpiPen malfunctions.
In 2016, NBC News reported that Mylan paid less than $35 for each EpiPen Meridian manufactured for the company. But between 2007 and 2016, Mylan raised the price of EpiPens 400 percent from $57 each to more than $600 for a two-pack – about $300 apiece. The company was able to take advantage of a lack of competition and its auto-injector patent to push aside competition while keeping customers who had few alternatives.
Did You Know
It is estimated that the epinephrine in a $300 EpiPen costs only about $1.
It is the auto-injector — not the medication — that makes EpiPen unique. It allows anyone to inject a precise dose of epinephrine in an emergency.
History of EpiPen Price Increases
EpiPen cost was just over $100 for a two-pack.
EpiPen prices rose to about $260.
EpiPen prices hit about $460.
Cost for an EpiPen two-pack topped $600.
The FDA first approved EpiPen in 1987, and Mylan acquired the right to market the device from Merck in 2007. At the time, EpiPen had a virtual monopoly, controlling about 90 percent of the auto-injector market. Mylan worked on improving the device and patented a new, improved injector in 2009 that improved its competitive place in the market.
EpiPen and EpiPen Jr. have dominated the auto-injector market since the first devices were approved in the 1980s. The devices have been licensed to different companies and the manufacturing operation has been involved in multiple mergers. Recent years have been rife with rising EpiPen costs and increased reports of EpiPen complications.
December 22, 1987
Survival Technology won FDA approval for first EpiPen.
Survival Technology merged with Brunswick Biomedical to create Meridian Medical Technologies.
Merck subsidiary Dey acquired exclusive license for EpiPen, Meridian continues to manufacture it.
Meridian recalled 1 million EpiPen and EpiPen Jr. devices because they didn’t contain the proper dose of epinephrine.
Mylan acquired right to market EpiPen devices from Merck.
Mylan and Meridian developed new design for EpiPen devices.
EpiPen adverse event reports to FDA increased sharply from an average of 16 per year to 172 in 2010.
Pfizer acquires Meridian and its parent company, King Pharmaceuticals, for $3.6 billion.
Congress, U.S. Department of Justice and state attorneys general investigated EpiPen price hikes that had increased 400 percent since 2007.
Mylan agreed to $465 million settlement with U.S. Department of Justice over Medicaid drug rebates for EpiPen devices.
Meridian recalls more than 80,000 EpiPen and EpiPen Jr. devices.
Class action lawsuits over EpiPen pricing are closed and moved to a Multidistrict Litigation in Kansas federal court.
FDA sent a warning letter to Meridian claiming the company failed to investigate reports of problems with EpiPen devices.
FDA reported adverse event reports over EpiPen and EpiPen Jr. more than doubled over the previous year.
In November 2017, on the heels of the skyrocketing prices, recalls and increased reports of EpiPen complications, FDA Commissioner Scott Gottlieb announced the agency would streamline an approval processes that could put generic competitors on the market more quickly.
FDA Guidance on Generic Alternatives to EpiPen
The guidance did not mention EpiPen specifically and could possibly be applied to certain other medical products.
“This will make it easier for generic firms to plan how they can copy complex drugs,” Gottlieb said.
Please seek the advice of a medical professional before making health care decisions.
Terry Turner is an Emmy-winning, former television journalist. He is an associate member of the American Bar Association, the ABA’s Health Law group and a member of the Alliance of Professional Health Advocates. He holds six certificates in Health Literacy for Healthcare Professionals from the Centers for Disease Control and Prevention. As a Washington-based investigative reporter, he routinely reported on health and medical policy issues before Congress, the FDA and other federal agencies. Terry received his B.A. in Media Arts from Lyon College.