Problems for the troubled Pfizer unit that makes EpiPen injectors for Mylan have opened on a new front. The U.S. Attorney for the Southern District of New York is now digging into the issues of why Pfizer continued to produce pens after receiving dozens of complaints that many were failing during life-and-death emergencies.
Pfizer disclosed in a public filing today that U.S. attorney in February made a civil investigative demand for records and information related to “alleged quality issues involving the manufacture of auto-injectors at our Meridian site.” Pfizer said it will be producing records in response.
The company on Friday declined to say anything beyond the statement in the filing or to say anything about the status of remediation of the plant in St. Louis, Missouri, that makes the injectors used to treat anaphylactic shock from allergic reactions.
Pfizer was quick to defend its operations in 2017 when it received the FDA warning letter that shredded the operation for failing to thoroughly investigate dozens of complaints that EpiPen and EpiPen Jr. products had failed, some of them "during life-threatening emergencies, including some situations in which patients subsequently died.”
At that point, the pharma giant said the company stood behind the quality and safety of its products and that it had no information indicating a cause and effect between the complaints and patient deaths.
The civil inquiry comes two years after the FDA conducted its month-long inspection of the facility’s manufacturing practices. It was then investigators discovered the facility had received 171 complaints about misfiring pens since the FDA's last visit. As the FDA was in the plant, Mylan recalled more than 80,000 injectors from around the world.
According to the warning letter, inspectors said Meridian let complaints pile up without figuring out the source of the problems. Some complaints were for EpiPen activation problems during use, and some for products that spontaneously dispensed epinephrine so that when a provider needed it for an emergency, there was no drug to inject.
The FDA pointed out that a year earlier during receipt testing of some incoming components, Meridian had discovered a defect in one of the critical parts. It rejected a couple of lots of components, then left it to the supplier to investigate the issue—a process that took eight months. The FDA criticized Meridian for not making the the connection that the defective part might be the source of the problems, a fact the FDA said it “ultimately confirmed.”
The FDA upbraided Meridian because it didn’t widen its own investigation to other potentially affected products and didn’t recall EpiPens from the market at that point.
For years, Mylan and its Pfizer-made pens were essentially the only product in the epinephrine injector market. Mylan's aggressively marketing and repeated price jumps, however, raised consumer, and eventually legislators’ ire. A lot has changed in the market in the last year. Teva and Novartis’ Sandoz unit both now have approved injectors on the market. Sandoz has set a wholesale acquisition cost for its Symjepi two-pack at $250, lower than the $300 price of Mylan’s authorized generic EpiPen and Teva’s generic version.