FDA on Tuesday announced that it is extending by four months the expiration dates for specific lots of EpiPens to address a shortage of the devices.
Background: EpiPen shortage hits US amid manufacturing delays
FDA in May announced that 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. FDA in 2017 cited a division of Pfizer—which manufactures EpiPens for Mylan—for violations of adequate manufacturing processes, and production of epinephrine auto-injectors declined as Pfizer sought to address the issues.
In response to FDA's May announcement, Mylan said it had notified FDA in advance about "intermittent supply constraints due to manufacturing delays from Pfizer."
The EpiPen shortage has been exacerbated by an additional shortage of an alternative made by Impax Laboratories. FDA in May said Impax's product was in short supply because of issues with the drugmaker's contract manufacturer.
FDA extends EpiPen expiration dates
FDA on Tuesday said it was "alerting health care professionals and patients of updated dates through which some EpiPens and the authorized generic version … may be used beyond the manufacturer's labeled expiration date."
FDA said data provided by Pfizer "supported" extended use dates for certain lots of EpiPens. Janet Woodcock, director of FDA's Center for Drug Evaluation and Research, said, "We've completed the necessary reviews of the data to extend the expiration date by four months for specific lots of EpiPen[s] … that are expired or close to expiring."
The lots affected by the extension can be found on FDA's website and Pfizer's website. According to Becker's Hospital Review, the extension applies to 0.3 milligram doses of EpiPen and its generic that have current expiration dates between April 2018 and December 2018. The extension does not apply to EpiPen Jr.
FDA said the agency could expand the lots of EpiPens with extended use dates as more data become available.
Woodcock said, "We're hopeful this action will ensure patients have access to this important medication and provide additional peace-of-mind to parents as the agency works with the manufacturer to increase supply."
Pfizer in a statement said, "Patients should have confidence in using the products from these particular lots as Pfizer works to stabilize supply, which is anticipated in the fourth-quarter of 2018." The company continued, "Currently supplies vary from pharmacy to pharmacy, and we cannot guarantee that product will be available at all pharmacies." Pfizer added that it "is working tirelessly to increase production and expedite shipments as rapidly as possible" (Frieden, MedPage Today, 8/21; FDA release, 8/21; Paavola, Becker's Hospital Review, 8/21; Hellmann, The Hill, 8/21).
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