Pfizer under fire for lacking safety protocols

On April 9, the FDA announced that Pfizer has failed to correct testing procedures in regards to clinical trials. The FDA says that over two dozen overdoses have occurred in patients participating in trials for the drug Geodon. The warning from the FDA comes on the heels of the federal court criticizing Pfizer’s in-house safety protocols and procedures.

The FDA issued a warning letter to Pfizer saying Pfizer is not properly monitoring physicians testing an experimental medication and as a result, more than two dozen patients have overdosed during the four-year trial. Pfizer first identified problems with the drug and dosing recommendations in 2006, but the FDA says they have failed to fix these procedures. The FDA has given Pfizer fourteen days to submit a new set of policies and procedures for overseeing care of patients within their clinical trials.

Over the last month, Pfizer has come under fire for lacking safety protocols. A former lab employee won a lawsuit against the company blaming ineffectual safety procedures for her contracting an immunovirus and now with clinical trials. Problems with safety are becoming a pattern for Pfizer, one they need to change before a major crisis, like death resulting from a trial drug, hits. Employees, stockholders, and consumers want to know that Pfizer is doing everything it can to keep them safe.

The FDA is providing Pfizer with their first opportunity to turn the pattern around and recommit themselves to safety. By re-evaluating their current safety procedures, Pfizer has the opportunity to figure out what can be improved upon. After evaluating safety protocols within clinical trials, Pfizer’s next safety area needs to be lab procedures. As the field of biopharmaceuticals grows and develops, the risks associated with lab work will grow. There is a need for advanced protocols throughout the entire industry and Pfizer can take this opportunity to put themselves ahead of their competitors.

Pfizer needs to re-evaluate all of its safety procedures and protocols in order to prevent a bigger crisis and avoid future legal troubles.