In a warning letter sent to Pfizer Inc., the Food and Drug Administration (FDA) threatened potential legal action over their negligent manufacturing of the emergency allergy treatment, EpiPen. The letter was drafted due to violations of “good manufacturing practices” at Pfizer manufacturing plants in Missouri between February and March of 2017. However, there are many more underlying issues, according to the letter. Pfizer subsidiary, Meridian, had been ignoring complaints about the functionality of the device. Their inaction had led to a number of serious injuries and deaths, although the exact number was not specified.
The pens’ distributor, Mylan, is the company that came under fire recently for unnecessarily hiking the price of the EpiPen six-fold.
The FDA’s initial interest in Pfizer was peaked in early 2016. Meridian found that a crucial component of the EpiPen, the portion that delivers the antihistamine, was defective. In some cases, the drug would leak out of the pen, rendering it useless. Other times, the drug simply would not inject properly or at all. The company continued to manufacture the same, flawed product while they were investigating the issue. They would later have to recall 260,000 EpiPens in the March of 2017 after being pressured to do so by the FDA.
Not surprisingly, both Meridian and the FDA received complaints during the period of this investigation concerning the drug not administering properly. Meridian dismissed these because they felt they were infrequent and, therefore, did not require attention. Pfizer also stated that “…it’s not unusual to receive product complaints, especially when the product is frequently administered by non-medically trained individuals”.
Between 2014 and 2017, the company received 171 complaints of improper injection, but they investigated “very few” of the claims and disassembled just as many potentially-broken product samples. Meridian did not offer an explanation for this inaction.
The letter was sent to Pfizer on September 5th. They must have a plan to address safety risks fifteen days from when the letter was sent. Not doing so could lead to legal action and other adverse consequences.