EpiPen and its manufacturer Mylan recently made headlines for price-gouging the life-saving device’s customers. Now, Mylan has a bigger problem on its hands: according to a new FDA report, customers are complaining their pens are malfunctioning.
Failure of EpiPens to deploy correctly have been cited in seven deaths this year through mid-September, according to reports by patients and physicians made to the U.S. Food and Drug Administration and obtained by Bloomberg News. The FDA received a total of 228 reports of EpiPen or EpiPen Jr. failures during the same time period, according to documents made available as a result of a Freedom of Information Act request. In addition to the deaths, 35 people were hospitalized, according to the reports.
You might remember the scandal surrounding the price of EpiPens, which are pen-like devices carried around by adults and children with fatal allergies.
EpiPen is sold by Mylan NV, a drugmaker legally based in the Netherlands but run from Pennsylvania, that was under fire last year for significantly raising the price of the allergy shot, from about $50 for a single pen to more than $600 for a two-pack. Congress held hearings, government agencies began inquiries, and rival Sanofi sued. The Paris-based competitor claimed Mylan sought “to preserve the monopoly position of their $1 billion crown jewel” by engaging in anti-competitive conduct. Mylan has denied any wrongdoing.
The company has been sued for the purported price gouging and 45 state attorneys general have alleged that Mylan and other drug companies have conspired to fix the prices of life-saving medications.
The number of complaints about the EpiPens has increased exponentially over the years.
Reports submitted by users to the FDA, however, show broadening accounts of malfunctions dating as far back as 2014.
In 2012 there were four reports of EpiPen and EpiPen Jr. failures to the FDA, followed by 12 in 2013, according to an agency database. In 2014, those reports jumped more than 400 percent, to 67, according to the reports obtained by Bloomberg.
“This is a lifesaving product,” Diana Zuckerman, president of the National Center for Health Research, said in an interview. “If it fails 105 times, that’s significant.”
You can add this to the growing list of controversies in the Mylan universe. Mylan’s CEO is Heather Bresch, daughter of Democrat Senator Joe Manchin. Manchin has received over one hundred thousand dollars in campaign donations from the embattled company. And then there is the question of the CEO’s compensation: Bresch’s salary rose 600 percent between 2007 and 2015. Let’s not forget about the cloud of alleged tax evasion hanging over the company. Now, just as Mylan’s EpiPen scandal was plastered across national headlines and television screens, Mylan has plastered ads around Capitol Hill promoting its “altruistic” image, no doubt to help further their piece of the current health reform pie. Nice try.
With the latest scandal of failing EpiPens under government scrutiny, let’s hope the DC political class doesn’t buy into this transparent attempt of Mylan to rehabilitate its image.