An attentive FDA intent on showing both the U.S. public and the drug industry that it has teeth has issued a warning letter to Pfizer. The citation concerns excessive dosing of an antipsychotic drug during a clinical trial, and it appears to have resulted, at least in part, by lack of communication to trial monitors of errors discovered by a Pfizer data management team.
Some 13 children and at least 20 adults received too much of the drug Geodon. The FDA inspection of the trial is part of the Bioresearch Monitoring Program, intended to protect human subjects. Warning Letter 10-HFD-45-04-01 cites "significant violations found during inspections of several clinical investigators."
According to the April 9 warning to Pfizer's PharmaTherapeutics Research & Development division, the regulator found a 2006 Pfizer report referencing dosing errors. A Pfizer data management team discovered the errors, which were missed by company monitors in nine site visits, according to a Reuters report.
A Pfizer report says lack of proper training led to the errors. But a year later, and following site personnel retraining, six more children received excessive doses, the FDA says.
The regulator also says that the drugmaker "failed to keep each participating investigator informed of new observations discovered by or reported to the sponsor on the drug, particularly with respect to adverse effects and safe use."
Warning letters are far more common in manufacturing operations than clinical trials, and the FDA has been clamping down on sloppy drugmakers not just for manufacturing missteps, but also for inadequate corrective follow-up, as reported in sister publication FiercePharma Manufacturing.