FDA Confirms Short-Term Shortages of EpiPen

The FDA Wednesday confirmed that there are “intermittent” shortages of Mylan’s EpiPen, an autoinjector device containing epinephrine to counteract the effects of anaphylaxis, but said it expects the delay to be short, while the manufacturer said the issue has to do with supply of third-party components.

The FDA added the product to its drug shortages list along with a generic product from Impax Laboratories. The estimated timeframe for the Impax product to return to full supply levels is unknown.

It is Mylan’s EpiPen device that is getting the most attention, however, after a patient advocacy group started surveying its members to see how widespread the shortages were across the country.

Until now, Mylan had been saying that it was shipping its product but that supplies may vary from pharmacy to pharmacy.

On Wednesday, the company released a statement saying that it had informed the FDA a few months ago of "supply constraints" from the manufacturer, Pfizer. Pfizer and its Meridian Medical Technologies unit make both the branded and unbranded versions of the devices. Mylan said it is still shipping the EpiPen and expediting shipments to wholesalers.

Pfizer also reiterated that the device is available in an email to The American Journal of Managed Care^® (AJMC^®). “We are currently shipping product and our shipments have been increasing over the last few months, with April shipments exceeding projections,” wrote Steve Danehy, director of corporate affairs. “The constrained supply of EpiPen is due to supply of certain third-party components, along with process changes implemented which have temporarily limited capacity at our manufacturing facility.”

Last September, the FDA sent a warning letter to Meridian for violating various current good manufacturing practice requirements for combination products and for ignoring hundreds of complaints about the EpiPen, including some where it failed to operate correctly and patients died.

“Drug shortages are most often caused by poor quality manufacturing; not by FDA compliance actions, or by warning letters,” an FDA spokeswoman, Lauren Smith Dyer, wrote in an email to AJMC^®, without commenting on Mylan and Pfizer’s specific situation. “Patients expect and deserve high-quality drug products. It is the manufacturer’s responsibility to ensure that its drug products are safe, effective, and of high quality. Preventing drug shortages is a top priority for the agency. The FDA is committed to working with manufacturers to resolve quality or manufacturing problems that arise to help ensure continued patient access to vital safe and effective drugs."

She said that the agency expects the shortages to be short-term.

“Multiple factors have resulted in limited availability of EpiPen in certain areas in the [United States], including both pharmacy-level supply disruptions and a manufacturer issue,” she wrote. “The FDA has been working closely with Mylan to understand the status of EpiPen production supply and has been in contact with the other manufacturers of epinephrine auto-injectors as well regarding their supply status.”

On Monday, Food Allergy Research and Education (FARE) called on the FDA to declare a shortage and take other actions to address the issue. It said that since May 2, more than 400 people in 45 states have filled out a survey indicating that they have experienced difficulties filling or refilling prescriptions at their local pharmacies. The survey also found that only one-third of those who tried to get an alternative device were able to do so. FARE said some people cited insurance coverage as a reason for not obtaining an alternative.

This time of year is typically a peak season for refilling epinephrine prescriptions, as those with life-threatening allergies typically need new ones after a school year ends or before leaving for vacation or camp.

On May 3, the American Society of Health-System Pharmacists issued a notice about the shortages.

Not affected are Kaléo’s voice-activated Auvi-Q, the other branded injector and a competitor to Mylan.

Batches of EpiPens were recalled in early 2017 in the US and in countries in Europe, Asia, and South America, and around the same time, the company was hit with a class-action lawsuit claiming the company struck a deal with pharmacy benefit managers. In 2016, the company's chief executive officer testified before Congress about the skyrocketing costs of the device, which climbed from less than $100 in 2007 to over $600 in 2016.