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Utilization of Post-Market Surveillance Data in Risk Assessment

The Food and Drug Administration (FDA) has regulatory oversight of products accounting for roughly 25 cents of every dollar spent in the U.S. But as any FDA official will tell you, the manufacturer bears the ultimate responsibility for the safety of its products in the marketplace.

FDA regulations and their primary statutory authority, the Federal Food, Drug, and Cosmetic Act (FFDCA), impose varying degrees of Agency premarket review and approval requirements on the marketers of drugs, foods, cosmetics, dietary supplements, medical devices, veterinary products, etc. However, even the very stringent and lengthy safety data requirements imposed on human drugs are, at best, a predictive tool that attempts to extrapolate, from effects in small, controlled study populations, the likely effects when the drug is used on a much larger segment of the U.S. population under largely uncontrolled conditions.

Thus, monitoring of a company’s product-food, drug, or device, once it is released into the marketplace becomes important, and, in some cases, a required mechanism for ongoing assessment of the real-world safety of the product. This “post-market surveillance”, as it is termed, can take many forms, but a common form is that of the Adverse Event Report (AER). Although AER data can prove to be a useful sentinel of unforeseen toxicity, the data have their limits, as evidenced by the scrutiny that such data have received recently as a consequence of the FDA’s attempts to regulate, and ultimately to remove from the marketplace, the dietary supplement ephedra.

AER and other post-market surveillance data collected by FDA, the American Association of Poison Control Centers (AAPCC), the Consumer Product Safety Commission (CPSC), and the Centers for Disease Control and Prevention (CDC), as well as proprietary data collected by individual companies on their own products, can be valuable sources of safety reassurance or sentinels of unforeseen hazards. The key to appropriate weighting of such data in risk assessment decisions is a keen awareness of the strengths and limitations of such data and how they are collected.

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