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FDA Warns Pfizer About Insufficient Oversight During Clinical Trial Involving Children

Posted By Regan Zambri & Long || 21-Apr-2010

Posted by: Salvatore J. Zambri, founding partner

The AP reports that in a warning letter dated April 9 and posted online April 20, the Food and Drug Administration said that Pfizer "has failed to correct problems with its testing procedures that resulted in overdoses of several children during a company trial" of "an experimental medication, which the agency did not name." However, a company spokeswoman said that medicine "is Geodon [ziprasidone], which the company was studying for children with bipolar disorder."

Bloomberg News reports that the letter posted to the agency’s website outlined "’significant violations’ discovered during an inspection of a Pfizer clinical trial site from May 4 to June 3." In 2005, the FDA warned Pfizer about the "lack of study monitoring that led to widespread overdoses," and "follow-up inspections in 2006 and 2007 also found dosing errors, the FDA said." The FDA has ordered Pfizer "to respond within 15 days with a plan to ensure that its studies comply with federal regulations."

The Wall Street Journal/Dow Jones Newswire reports that Pfizer is currently seeking agency approval of Geodon to treat bipolar disorder in patients ranging in age from 10 to 17 years old, which the FDA declined to do six months ago, citing a need for more information. The medication is currently approved for the treatment of schizophrenia and bipolar disorder in adult patients, however. Meanwhile, the Journal quotes Pfizer as stating that it "recognizes the seriousness of the issues cited by the FDA and is committed to fully addressing FDA’s concerns."

Reuters reports that even though 13 children suffered from overdosing during the clinical trial, none was injured or subjected to ongoing side effects, and only two youngsters had to be taken out of the clinical trial. Since the overdosing incidents, seven found by the FDA and six documented in the pharmaceutical company’s own internal memoranda, Pfizer said it "has instituted several new measures designed to improve monitoring and execution of clinical trials, including our oversight of clinical investigators."

Medications for children are necessary. But so is safety. In an effort to create effectove drugs, companies should never risk the health of those utilized in a clinical trial. Safety over profit must be the goal.

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About the author:

Mr. Zambri is a Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledges him as "one of Washington’s best–most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri has also been repeatedly named a "Super Lawyer" by Law and Politics magazine–a national publication that honors the top lawyers in America.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.

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