TheFDAsPost-marketingAdverseDrugExperienceInspectional.ppt

Denis Mackey - ADE The FDA’s Postmarketing Adverse Drug Experience Inspectional Program Surveillance Programs Team Office of Compliance Center for Drug Evaluation and Research U.S. Food and Drug Administration AGENDA Postmarketing adverse drug experience reporting regulations Role of headquarters and field Inspectional strategies Purpose of ADE Regulations To obtain additional information on adverse events that may not have been detected prior to marketing To improve the labeling of drug products Brief Overview of Reporting Regulations 21 CFR Sections: 310.305 - RX drugs not subject to approved applications 314.80 - RX drugs subject to NDAs/ANDAs and OTCs associated with approved applications 314.98- RX drugs subject to AADAs What is an Adverse Drug Experience? Any adverse event associated with the use of drug in humans whether or not it is considered drug related. Serious Adverse Drug Experience Death Life threatening (per initial reporter) Permanently or significantly disabling Hospitalization Congenital anomaly/birth defect Important medical events Unexpected Adverse Drug Experience Not listed in current labeling Listed in labeling but greater specificity or severity e.g. renal impairment listed, patient experiences renal failure Reporting Requirements Within 15 calendar days if Serious and Unexpected (domestic and foreign) Follow-up information Non-applicant notifies applicant within five calendar days Periodic Report Quarterly and Annual Reports Serious Expected ADEs All Non-serious When does the Regulatory Clock Start? First day a firm or any affiliate receives event data containing all four elements: An identifiable patient An identifiable reporter A suspect drug An adverse event or fatal outcome Forms 3500A (Medwatch Form) Council for International Organization of Medical Science (CIOMS I Foreign) or other form if approved in advance The Headquarter/Field Adverse Event Team The headquarters scientists use adverse event reports to evaluate the saf