What Is FDA's Role In Minimizing Risk?
Traditionally, FDA has filled several important roles in minimizing the risks associated with using medical products. The Agency establishes and enforces product quality standards intended to prevent defective products from reaching the market. For products of acceptable quality, the central element of FDA's risk management is controlling product entry to the marketplace. The majority of FDA program resources are devoted to premarketing scientific risk identification and assessment and approval or nonapproval. Significant, but substantially fewer, resources are devoted to postmarketing surveillance and risk assessment activities. The Agency's role in premarketing risk identification and assessment and postmarketing surveillance and assessment are depicted in the following figure and described briefly here.
Premarketing risk identification and assessment
FDA's premarketing review process quantifies risks detected during the clinical development of a medical product and evaluates how carefully any potential risks were assessed by the product's manufacturer. Risks related to drug-drug interactions and the potential for medication or device error are assessed. The known risks, along with any deficiencies in safety testing, are then weighed during the approval decision and described in the labeling of approved products.
Deciding whether a product's benefits outweigh its risks inevitably involves making judgments. The decision-maker must weigh a variety of complicated information and take into account a number of other considerations. The need for judgment means there can be disagreement. FDA attempts to deal with any differences of opinion by obtaining input from advisory committees and public hearings, and by systematic, documented review procedures and decision records. Part 2 of this report discusses the scientific and procedural quality of the FDA's premarketing review process and evaluates whether it is performing as well now as it was prior to the implementation of PDUFA.
Postmarketing surveillance and risk assessment
FDA's postmarketing risk surveillance and assessment, which are described in more detail in Part 3 of the report, rely primarily on two methods of adverse event reporting to the Agency: (1) direct, voluntary reporting by health professionals and consumers and (2) mandated reporting by pharmaceutical manufacturers. Mandated reporting by manufacturers is based primarily on the voluntary submission of reports to manufacturers from user facilities, healthcare professionals, and consumers. Within the Agency, medical, statistical, and epidemiological experts use these reports to continually evaluate a product's record.
The Agency's postmarketing surveillance programs focus primarily on (1) identifying events that were not observed or recognized before approval, and (2) identifying adverse events that might be happening because a product is not being used as anticipated.
During the past decade, FDA has improved its methods for obtaining and assessing postmarketing information related to adverse events. The Agency's approaches to postmarketing risk assessment enable it to assess the likelihood and seriousness of adverse events to weigh them against the benefits of using a medical product. Once new risks have been identified and assessed, a decision about the effect on overall safety must be made and the appropriate actions taken. Actions can include requiring an update of a product's labeling information, sending out a Dear Healthcare Professional letter, or rarely, reevaluating an approval decision.