Federal regulators say that Pfizer has failed to correct problems with its testing procedures that resulted in overdoses for more than two dozen patients during a company trial. The FDA issued a warning letter saying Pfizer is not properly monitoring physicians testing Geodon, an experimental medication. Pfizer is studying this drug in relation to children with bipolar disorder.
The FDA warning, posted online, follows up on problems first cited in 2006, when 26 patients in a company trial received overdoses of the psychiatric drug. Despite Pfizer retraining the physicians, FDA says three additional overdoses occurred in 2007. A July 2009 inspection, which prompted the new warning, found Pfizer was still not following its own guidelines for safely conducting the study. Specifically, FDA inspectors said that the company was not alerting clinical investigators to new dosing problems as they occur. While Pfizer responded to the agency’s complaints in July, the FDA letter states that “the response did not contain a detailed outline of procedures or processes that would be implemented to prevent the future occurrence of these observations.”
The FDA is demanding that Pfizer submit a plan for correcting the problems. Geodon, part of the antipsychotic drug class, is already approved to treat schizophrenia and bipolar disorder in adults. Side effects include diabetes, facial spasms and seizures. The FDA regularly issues warning letters to companies that do not follow regulations for manufacturing, marketing and testing. While the letters are not legally binding, the agency can take companies to court if they are ignored.
Source: USA Today
Contact us today for a free legal consultation with an experienced attorney.
Fields marked *may be required for submission.
If you would like to subscribe to the Jere Beasley Report digital edition, simply visit our Subscriptions page and provide the necessary information or call us at 800-898-2034.
Attorney Advertising - Prior results do not guarantee a similar outcome.