The Food and Drug Administration issued a scathing warning letter to a Pfizer Inc. 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.
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The product delivers a jolt of epinephrine, a synthetic form of adrenaline, to patients including school children who are going into shock from causes such as bee stings and allergies to food, drugs and other substances.
"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."
In a written statement late Thursday following the warning letter, Pfizer said 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 didn't address most of the letter's specifics in its statement but said it is "very confident in the safety and efficacy of EpiPen products being produced at the site."
Pfizer said it doesn't have any information "to indicate that there was any causal connection between these product complaints and any patient deaths."
The warning letter followed a March inspection by the FDA of Meridian's manufacturing site in Brentwood, Mo., after which Pfizer began recalling some EpiPen devices in the U.S. and elsewhere.
Mylan said it is "confident in the safety and efficacy of EpiPen products" and said Pfizer's recall of some EpiPen lots "was taken as a proactive and precautionary measure." It added that Mylan doesn't foresee any supply issues resulting from the warning letter.
The FDA said it had conducted an earlier inspection of the manufacturing facility in Missouri, and it found "similar" violations of good-manufacturing standards on both occasions. "These repeated failures demonstrate that your facility's oversight and control over the manufacture of these products is inadequate," the FDA wrote.
The letter detailed the repeated nature of complaints and what the agency terms as the company's allegedly "failing to disassemble the vast majority of complaint samples."
FDA inspectors identified a defect in a component of the injectors and noted that the company then expanded its investigation of affected lots and recalled 13 lots distributed in the U.S. But the FDA said these steps transpired after prodding by the FDA.
"While you eventually expanded the scope of the investigation" into the faulty component and recalled all 13 product lots affected, the FDA letter said, "you did so only after our inspection closed and after multiple discussions with FDA."
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(END) Dow Jones Newswires
September 07, 2017 19:30 ET (23:30 GMT)