Glossary A-AD

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Abbreviated New Drug Application Fraud (ANDA) – an application submitted for the approval of a drug which contains no clinical trials sponsored by or on behalf of the applicant; instead, it relies on the approved application of another drug with the same active ingredient to establish safety and efficacy. Drugs approved via this method are referred to as generic drugs. Generic drug fraud can take the same form as fraud involving drugs approved by an NDA (New Drug Application), including but not limited to: falsified representations made in the ANDA submission; falsified records to cover up deviations from approved manufacturing processes; and false annual reports.

Acute Care Hospital Fraud – See Long Term Care Hospital Fraud in the Glossary.

ADE Fraud – See Adverse Drug Experience Fraud in this Glossary.

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.

Adverse Events Fraud for Devices – failure to report Adverse events as required by law, typically in the manufacturers’ annual report.