Posted by: Salvatore J. Zambri, founding partner
According to an AP report, the Food and Drug Administration issued a warning letter to “Pfizer Inc. for failing to promptly report complaints with its drugs that may have involved serious injury.” In the 12-page letter, dated May 26, the FDA “cites a number of product complaints which were not reported to government regulators within the required 15 days.” The letter also “demands that Pfizer submit a plan for correcting the problems within 15 business days.”
The Wall Street Journal also reports that this FDA warning letter to Pfizer is the second one this year. Two months ago, the company received an agency warning regarding pediatric clinical trials of the antipsychotic Geodon (ziprasidone). The Journal points out that the latest warning results from a 2009 inspection of Pfizer’s headquarters, an inspection which the agency said was to ascertain Pfizer’s compliance with reporting rules regarding adverse events after drugs are allowed on the market. Specifically, the letter said the agency discovered that some adverse-event reports were not actually reported until after its inspection was conducted. The drugs involved were Lyrica (pregabalin) and Lipitor (atorvastatin).
Per a Reuters report, the Food and Drug Administration has asked to meet with Pfizer to discuss the violations. For its part, Pfizer promised to work with the FDA to address and remedy the problems.
Obviously, we need medication to maintain and promote health. However, it is critically important for pharmaceutical companies to accurately and timely report the dangers of the drugs they make and sell, so that doctors and patients can properly evaluate the risks and benefits of the drugs. Safety must always trump profits.
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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, serious automobile accident claims, and other personal injury actions. 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.defective product, FDA, medications, productliability, U.S. Food and Drug Administration Warnings