EpiPen manufacturer is accused of lax investigation into problems.
The FDA has sent a warning letter to a Meridian Medical Technologies in Columbia, MD. Meridian is owned by Pfizer, but manufactures EpiPen and EpiPen Jr. on behalf of Mylan. According to the FDA, Meridian is guilty of shoddy manufacturing practices and lax investigational operations.
The letter comes after months of public outrage over price increases and a long legal battle over allegedly defrauding Medicaid that Mylan settled for $465 million.
On February 1, 2016, Meridian identified a failed unit from a lot of EpiPen components-a component that ensures that the device injects epinephrine into the patient. Meridian rejected that lot of components, along with one other lot of the same component. However, the FDA alleges that while Meridian ordered the supplier to conduct an investigation into the problem, they continued using other lots from that supplier until their investigation closed in October 2016. Meridian did not expand their own investigation or review incoming test procedures to identify problems.
The FDA also claims that Meridian did not link the component failure with hundreds of reports of EpiPen failures. Some of these complaints resulted in patient deaths. Most of the complaints regarded activation failure-including some spontaneously dispensing the drug before usage, rendering the device useless in an emergency. According to the letter, Meridian did not adequately investigate those complains and it did not recall defective units even after identifying that a component was the root cause of multiple complaints.
In one example, Meridian received a complaint on April 28, 2016, of a device failing to activate. After launching an investigation, it was found that the cause of the problem was the failure of a component. However, they did not investigate further to determine if they problem was linked to the February 2016 failed lots and they did not issue a recall-even though the supplier’s investigation was still ongoing and Meridian had not examined the remaining lot of components related to the April 2016 failure or any other associated lots. Only after an FDA investigation did Mylan recall 13 distributed lots.
Related article: EpiPen and EpiPen Jr. Recalled: Recall Expanded from Europe and Asia
Between 2014 and 2017, Meridian received 171 complaint samples of products failing to activate after patients did everything correctly. The site quality lead at Meridian told the FDA that in order to identify defects in the suspected component, the component would need to be dissembled. The exact number of lots Meridian disassembled was redacted from the letter, but it does say that “vast majority” of the samples were not disassembled.
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According to the letter, Meridian’s reasoning is “inadequate” for why it failed to identify the scope and frequency of the component defect and for why they took little action.
Complaint procedures at Meridian were also deemed “inadequate.” Any complaints were ranked on a scale from expedite, high, and normal. This scale, according to the FDA is deficient because it doesn’t prioritize complaints based on risk to patients. For example, complaints relating to “failure to active” were marked as expedite. However, complaints relating to spontaneous activation were marked as normal, the lowest priority, even though both complaints would result in the patient not receiving the drug when they used the device.
Related article: Are EpiPens Still Good After Their Expiration Date?
The FDA is requiring Meridian to provide a detailed review of all of its manufacturing investigations and future plans for addressing patient safety and product quality concerns. If it does not adequately answer the FDA’s requests for information, it could face shutdown and other legal troubles.
In a statement, Mylan said that "Pfizer is continuing to work with FDA to resolve the points raised in the letter regarding Pfizer’s manufacturing of EpiPen Auto-Injector and Mylan will do whatever it can to support this process. We note that Pfizer’s recall several months ago of certain lots of EpiPen Auto-Injector was taken as a proactive and precautionary measure with FDA in relation to these issues. Mylan has an unwavering commitment to quality and patient safety and we are confident in the safety and efficacy of EpiPen products being produced at the site. Further, we do not currently anticipate any supply issues as a result of the warning letter.”