FDA on Wednesday announced Mylan's EpiPens—epinephrine auto-injectors that deliver life-saving treatment for allergic reactions—are in short supply in the United States because of manufacturing delays.
Advocacy group detects shortage
According to The Hill, the announcement comes after Food Allergy Research and Education (FARE) this week called on FDA to "take immediate action to address a growing national shortage" of EpiPens. FARE in a survey of its members found that since May 2, more than 400 people in 45 states have reported difficulty filling their EpiPen prescriptions. In addition, Erin Fox, senior director of University of Utah Health's drug information and support services, which track drug shortages, said, "We've received quite a few reports that people are having trouble accessing products."
Separately, Mylan in a statement Wednesday said it notified FDA a few months ago about "intermittent supply constraints due to manufacturing delays from Pfizer," which manufactures the EpiPen for Mylan.
According to the Wall Street Journal, FDA last year cited a division of Pfizer for violations of good manufacturing processes, and production of epinephrine auto-injectors declined as Pfizer sought to address the issues.
FDA said the current supply status of Mylan's epinephrine auto-injectors—including the EpiPen, EpiPen Jr., and the company's generic versions of the EpiPen and EpiPen Jr—is available, but the agency noted that "supply levels may vary across wholesalers and pharmacies." FDA spokesperson Lauren Smith Dyer added that the agency, based on information provided by Pfizer, "anticipates the EpiPen shortage [will] be short-term."
In addition, FDA said an alternative to the EpiPen, made by Impax Laboratories, is also in short supply, because of issues with the drugmaker's contract manufacturer.
Mylan said EpiPens remain available in the United States, but that some pharmacies do not have the product in stock. Mylan said it can help patients find pharmacies with EpiPens.
Separately, Pfizer in a statement said, "We are currently shipping product and our shipments have been increasing over the last few months, with April shipments exceeding projections" to address the shortage (Sullivan, The Hill, 5/9; Erman, Reuters, 5/9; Rockoff/Loftus, Wall Street Journal, 5/9).
From outbreaks to shortages: How can your hospital prepare for disasters?
Hospitals must be prepared for myriad disasters that can stress health care systems to the breaking point and disrupt delivery of vital health care services.
Advisory Board has compiled step-by-step procedures for various threats your facility may encounter—though we hope you'll never need to use them.