September 8, 2017
By Alex Keown, BioSpace.com Breaking News Staff
WASHINGTON – The U.S. Food and Drug Administration had some harsh words for Pfizer division Meridian Medical Technologies, Inc. , the company that manufactures the EpiPen Auto-Injector for Mylan .
On Sept. 5, the regulatory agency scathing warning letter regarding the manufacturing practices at Meridian. In the letter, the FDA said Merdian “failed to thoroughly investigate any unexplained discrepancy or failure” of the EpiPen and EpiPen Jr. products it manufactures. The FDA said Meridian received hundreds of complaints regarding EpiPen failures – failures that lead to some deaths from anaphylaxis. The FDA did not indicate how many EpiPen users had died as a result of the failures. The FDA said the products failed to operate as intended, meaning the life-saving epinephrine inside was not dispensed. Additionally, the FDA noted that some EpiPens “spontaneously dispensed epinephrine prior to use” and the drug was not available to the patients when needed.
“You failed to thoroughly investigate multiple serious component and product failures for your EpiPen products, including failures associated with patient deaths and severe illness. You also failed to expand the scope of your investigations into these serious and life-threatening failures or take appropriate corrective actions, until FDA’s inspection,” the FDA letter said.
That failure to investigate occurred even though Meridian received hundreds of complaints, the FDA noted. During the three year period of 2014 to 2017, the FDA said Meridian records show the company received 171 complaint samples for products that failed to activate when patients followed proper procedure. In its criticism, the FDA said Meridian only disassembled a few of those products. A company quality control officer told the FDA that it was policy to disassemble the defective products but added that Meridian initiated a policy not to do so unless instructed by management.
“You offered no further explanation for failing to disassemble the vast majority of complaint samples you received over nearly three years, even though you concurred that disassembly would have been necessary to determine if a defective was present,” the FDA said.
Meridian, the FDA said, collaborated with its supplier to address the root cause of the complaints. However, the FDA said the response was inadequate and the company did not explain why the investigation “failed to identify the scope and frequency of the component defect, or why you had previously concluded that this component defect occurred too infrequently to warrant a market action.”
The FDA warned Meridian that it must correct the issue immediately. If it does not do so, legal action may be taken against the company.
Pfizer spokesperson Kim Bencker told the New York Times that the company is “very confident in the safety and efficacy of EpiPen products being produced at the site.” Bencker also said that since 2015.
“It’s not unusual to receive product complaints, especially when the product is frequently administered by non-medically trained individuals,” Bencker told the Times. “We currently have no information to indicate that there was any causal connection between these product complaints and any patient deaths.”
A spokesperson for Mylan, the primary distributor of the EpiPen, told CNBC that Pfizer is doing what It can to address the FDA criticism and that Mylan will “do whatever it can to support this process.” The Mylan spokesperson added that the company does not anticipate any shortage of EpiPen products due to the Meridian issues.
Earlier this year, Meridian and Mylan issued a voluntary recall of EpiPens following reports outside of the U.S. of failure to activate.
