- On Wednesday morning, the Food and Drug Administration updated its drug shortage list to include Mylan's epinephrine auto-injector EpiPen.
- The agency noted the drug is currently in short supply due to manufacturing issues, but is listed as available. EpiPen is manufactured by Meridian Medical Technologies, a subsidiary of Pfizer.
- The specialty generic of EpiPen, which is also made by Mylan and manufactured by Pfizer, is also in shortage, as is an epinephrine injection from Impax Laboratories, according to the FDA list.
This isn't the first time that there have been problems with production of the emergency treatment for allergic reactions. Last September, the FDA slapped Meridian Medical Technologies with a warning letter, citing quality controls, handling of product and defective auto-injectors — among other issues — with the product.
EpiPen is designed to be used in emergency situations and is often handled by children or caregivers who are inexperienced with the drug/device combo. Therefore, it's of the utmost importance that the easy-to-use auto-injector work when needed.
"Your 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," the agency said in the September letter.
The warning letter cites issues at the Meridian manufacturing facility dating back more than a year. During that time, Mylan voluntarily recalled several batches of the product after some were found to have defective devices.
The manufacturing issues at Meridian expanded further, causing a shortage in Canada in the early part of 2018.
"Mylan and Pfizer take the supply of EpiPen and EpiPen Jr Auto-Injectors very seriously," said Mylan in a statement.
"A few months ago, Mylan informed FDA of intermittent supply constraints due to manufacturing delays from Pfizer. Since this time, Mylan and Pfizer have remained in close contact with FDA to provide regular updates on the inventory status," the company added.
"We are currently shipping product and our shipments have been increasing over the last few months, with April shipments exceeding projections," said Pfizer in a statement to BioPharma Dive. The FDA website notes Mylan is receiving continual supply of the drug from Meridian and shipping to wholesalers upon receipt of the product.
While once the crown jewel of Mylan's product portfolio, the trouble over manufacturing, increased competition and a pricing scandal have tarnished the EpiPen brand. Mylan faced pushback two years ago when it came to light the company increased the price of a two-pack from $200 in 2007 to more than $600 in 2016. Mylan has since lowered the price of EpiPen for certain patients and has also launched its own authorized generic that costs half the price.
Yet the damage was done, and several competitors have now crept into the market. The manufacturing issues and shortages have only heightened the problem.
Mylan didn't specifically break out the sales of EpiPen in its first quarter earnings report on May 9, but noted that North American sales declined 19% to $985.3 million during the period, in part due to lower sales of EpiPen.