FDA Warns Of Manufacturing Violations To EpiPen Plant

(RTTNews) - The Food and Drug Administration issued a warning letter to a Pfizer Inc. (PFE) unit that manufactures the emergency auto-injector EpiPen, saying the company "failed to thoroughly investigate" product failures even in cases of patients' deaths.

The EpiPen, sold by Mylan NV, is manufactured by Pfizer's Meridian Medical Technologies Inc. unit. The injector has been in the headlines for sharp price increases, but the FDA now is putting the spotlight on the device over quality issues

"Your own data show that you received hundreds of complaints that your EpiPen products failed to operate during life-threatening emergencies, including some situations in which patients subsequently died," the FDA wrote in the letter this week to Thomas E. Handel, Meridian's president and general manager.

The FDA ordered the company to correct the violations cited in the letter and warned that "failure to promptly correct these violations may result in legal action" including seizure and injunction.

The FDA reported that between 2014 and 2017, Meridian's records show that it received 171 "complaint samples" for injectors "that failed to activate when the patient followed the proper sequence."

Meanwhile, Pfizer said Thursday that "between 2015 and now, we have shipped more than 30 million EpiPen auto-injectors globally. It's not unusual to receive product complaints, especially when the product is frequently administered by nonmedically trained individuals."

Pfizer said it is "very confident in the safety and efficacy of EpiPen products being produced at the site."

Pfizer noted it doesn't have any information "to indicate that there was any causal connection between these product complaints and any patient deaths."