The Food and Drug Administration has accused a Pfizer unit of failing to investigate reports that EpiPens malfunctioned in life-threatening situations. The agency cited multiple incidents where patients died or became severely ill after the device failed to work. A spokeswoman for the F.D.A. did not provide details about the number of patient deaths reported.
Pfizer manufactures the EpiPen for drugmaker Mylan. The company has shipped more than 30 million EpiPens since 2015. Last year, Pfizer made $386 million from the product. A year ago, reports that Mylan had sharply raised the price of the product led to Congressional inquiries. In August, Mylan finalized a $465 million settlement with the U.S. Department of Justice over claims of overcharging the federal government for the product.
In this latest issue, a warning letter, dated Sept. 5, was sent to Pfizer’s Meridian Medical Technologies division. In the letter, the agency said that its data shows the unit received hundreds of complaints of EpiPens failing to operate correctly. Between 2014 and 2017, the Pfizer unit received 171 product samples that were the subject of complaints.
The F.D.A. cited some cases where the injectors didn’t work properly and others where the epinephrine in the EpiPens leaked, leaving no drug left when patients needed it. The mechanism on the device that insures that it fires and delivers the proper dose of epinephrine was found to be the cause of the issues.
Even after identifying the faulty part, Pfizer didn’t remove potentially defective products from the market until after being pushed by the FDA. Pfizer and Mylan recalled 13 lots of the EpiPen in the United States and overseas markets earlier this year because of the issues.
The F.D.A. said the company failed to conduct a proper investigation despite the numerous complaints. The agency wrote that the company “failed to thoroughly investigate multiple serious component and product failures for your EpiPen products, including failures associated with patient deaths and severe illness.” The F.D.A. told Meridian to correct the violations promptly.
A spokeswoman for the company said in a statement that it was “very confident in the safety and efficacy of EpiPen products being produced at the site.” Pfizer said in a statement, “It’s not unusual to receive product complaints, especially when the product is frequently administered by non-medically trained individuals.” Mylan doesn’t expect a shortage of product to occur because of the warning.