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Adverse Drug Experience Fraud

Any adverse event associated with the use of a prescription or OTC drugs with approved applications. The purpose of postmarketing Adverse Drug Experience surveillance is to obtain information on rare, latent or long term drug effects not identified during premarket testing. Sponsors, manufacturers, packers and distributors are required to report all serious, unexpected (not listed in the drug product’s current labeling) or life-threatening ADEs to the FDA within 15 calendar days, in what is referred to as a “15-Day Alert Report.” A serious ADE is one that is fatal or life-threatening, persistent or significant disability/incapacity, or requires inpatient hospitalization, or a prolongation of existing hospitalization, congenital anomaly, cancer and so on. In addition, manufacturers are required to file “Postmarketing Periodic Reports,” which are to include all ADEs whether “serious” or not. These Reports are due quarterly for the first three years after U.S. approval of the NDA, and yearly thereafter. Failure to report ADEs is fraud and can be the basis for a qui tam lawsuit.

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