FDA Warns Pfizer's Meridian Unit on EpiPen Oversight, Quality Issues
September 07 2017 - 7:45PM
Dow Jones News
By Thomas M. Burton
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.
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."
Write to Thomas M. Burton at tom.burton@wsj.com
(END) Dow Jones Newswires
September 07, 2017 19:30 ET (23:30 GMT)
Copyright (c) 2017 Dow Jones & Company, Inc.
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