Pharma Industry Regulation
22.0K views | +7 today
Scooped by Pharma Guy
onto Pharma Industry Regulation!

A Pfizer Company that Makes EpiPen Devices Failed to Investigate Patient Deaths Says FDA

A Pfizer Company that Makes EpiPen Devices Failed to Investigate Patient Deaths Says FDA | Pharma Industry Regulation |

Meridian Medical Technologies, Inc. a Pfizer Company that makes the EpiPen device for Mylan, failed to investigate “serious” problems associated with patient deaths, according to an FDA letter.


“Among other things,” said FDA in its letter to Meridian, “you manufacture two epinephrine auto-injectors at your facility, EpiPen and EpiPen Jr., (collectively, EpiPen products). These products are intended to deliver a lifesaving drug (epinephrine) during emergency treatment of serious allergic reactions, including anaphylaxis. If your auto-injectors do not operate as expected and deliver the intended amount of epinephrine drug when deployed in emergencies, patients can die or suffer serious illness. You failed to thoroughly investigate multiple serious component and product failures for your EpiPen products, including failures associated with patient deaths and severe illness. You also failed to expand the scope of your investigations into these serious and life-threatening failures or take appropriate corrective actions, until FDA's inspection.


“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. Many of the complaints related to product activation failures, including failures to activate when the user followed the operating instructions, as well as failures for products that spontaneously dispensed epinephrine drug prior to use so that the drug was no longer available when the user attempted to activate the product. You did not thoroughly investigate these complaints. Moreover, we note that your follow up did not include removing potentially defective products from the marketplace, even though you had identified a defect in one of the critical components used to manufacture these products and even though you ultimately confirmed the same or similar component defect as the root cause for multiple complaints.”

No comment yet.
Pharma Industry Regulation
Stories & Insights Regarding Marketing Regulations & Guidelines
Curated by Pharma Guy