Pfizer responds to FDA, EMA and Canada after reinspections of plant that makes injected painkillers

Pfizer says it has made significant strides in upgrading the sterile injectables plant where it manufactures many of its generic painkillers but acknowledges more must be done after reinspections by the FDA and other regulators.  

The FDA, along with teams from the European Medicines Agency and the Health Canada, concluded reinspections this month at the plant in McPherson, Kansas, that has been at the heart of shortages at U.S. hospitals of injected painkillers. Pfizer its is responding to observations about some of the plant’s “practices and processes,” according to an internal Pfizer memo obtained and posted by STAT.

"Although we have demonstrated improvement in many areas, we are still on a journey to drive further improvement and meet our commitments to both our regulators and our patients," site leader Carole Johnson told employees in the memo.

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The FDA last year issued a warning letter to the former Hospira plant where Pfizer produces a broad portfolio of generic sterile injectables, as well as does contract work for clients. The problems derailed approval of Sandoz’ and Momenta’s generic of Teva blockbuster Copaxone, for example. The drug was approved earlier this year after the FDA found enough improvement at the plant to upgrade the status to Voluntary Action Indicated (VAI).

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Pfizer today in an email said that while production at some modules at the plant was interrupted while new HEPA filters were installed, “The vast majority of site operations was not impacted. The site has operated continuously since the last plant maintenance period in the first quarter of 2018.”

Still, because the plant is responsible for so much of the country’s injectables painkiller supply, production interruptions have left hospitals scrambling for supplies to provide routine patient care. The amount of opioids that any company can produce is determined by the Drug Enforcement Agency. While Pfizer this spring resumed production of those products, the DEA gave some of its narcotics quota to competitors to address ongoing shortages.

Pfizer also stopped shipments of injected painkillers to veterinarians and said it won’t resume sales for animal use until the shortage at hospitals and surgical facilities has been resolved, which is not expected before the second quarter of 2019.