Despite our reporting on the shortage of EpiPens in April of last year, it took the Food and Drug Administration (FDA) weeks to finally acknowledge what we knew all along: supply was drying up.
In March of this year, we reported the shortage was continuing to drag on as the FDA renewed the citation in their database that the manufacturer was continuing to experience delays.
Now, an article published in WebMD Health News cites a source at Pfizer — the manufacturer of EpiPen and Mylan’s Generic version — as claiming the shortage will continue for an extended time.
“Despite our significant efforts, we do anticipate further supply shortages over the coming months,” Said Steve Danehy, director of media relations at Pfizer.
“We share in the frustration over the fluctuating availability but, as with many sterile injectable medicines, EpiPen requires a highly complex and technical manufacturing and assembly process,” Danehy added.
Mylan, the marketer and distributor of EpiPen, issued the following as part of a written statement to WebMD:
We appreciate how important it is for individuals with life-threatening allergies to have access to epinephrine auto-injectors and understand the frustration this ongoing situation continues to pose to patients and caregivers.
As we reported, the delays are due to significant problems at Pfizer’s Meridian unit which was warned by the FDA over the company’s handling of EpiPen malfunctions back as far back as September of 2017.
Quoting from the letter:
Our 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.
In an effort to address the shortage, Pfizer issued a statement extending the expiration date for select lots of EpiPen.
In the meantime, we encourage families unable to fill their EpiPen prescriptions to research other brands, some of which have come on the market in recent months. You can find our most recent summary of EpiPen alternatives complete with website links and how-to-use videos by clicking here.