Business Insider Report Details Pfizer and Meridian's Negligence in Addressing EpiPen Failures
Posted on January 31, 2019 by Medtech[y] Staff
Business Insider was the first to report on the FDA's warnings to Pfizer/Meridian back in 2014, the subsequent action from Meridian, and critical details of how Meridian handled the complaints that would lead to a large voluntary recall. In their report, Business Insider obtained hundreds of pages through a public-records request.
What to Know:
- Complaints about EpiPens not working or arriving in bad shape began to mount in 2013 and 2014.
- The manufacturer, Meridian Medical Technologies, didn't properly look into those complaints, FDA inspectors warned as far back as 2014. Meridian didn't make significant changes to its complaint-investigation process until three years later, after a major voluntary recall of EpiPens.
- "In fact, 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 FDA said in a 2017 letter.
- Pfizer responded by saying that "no evidence has been found of a causal link between patient deaths and reports of failure of EpiPen units to activate."
- This occurred as Mylan, the drugmaker that markets and distributes the EpiPen, hiked the price, which sparked controversy. As a result of the FDA's warning letter, new processes at EpiPen factories have contributed to an EpiPen shortage.
- Business Insider is first to report on the FDA's 2014 warnings, the action taken by Meridian, and critical details of how Meridian handled the complaints that would lead to the recall.
- Pfizer told us that "since the inspection in 2017, the Meridian manufacturing site has been diligently implementing all commitments made to the FDA."
This report is eye opening considering EpiPens are incredibly critical to patients and their lives. You can read the original report here.