Postmarket drug safety surveillance practices under scrutiny
In 2016, the 21st Century Cures Act (Cures Act) amended the Federal Food, Drug, and Cosmetic Act to eliminate the requirement for the Food and Drug Administration (FDA) to prepare a summary analysis of adverse drug reaction reports received for a drug by 18 months following approval of the drug or after 10,000 individuals have used the drug, whichever occurs later. As an aside, the Cures Act also required the FDA to make its best practice for drug safety surveillance publicly available on the web.
Thus last week the FDA announced the availability of “Best Practices in Drug and Biological Product Postmarket Safety Surveillance for FDA Staff,” a document outlining the agency’s approach for timely postmarket analyses of drugs and biologics, and includes a high-level overview of tools, methods, and signal detection and evaluation activities, using varied data sources, for drug safety surveillance to provide a broader context and a general overview of our overarching effort and commitment in this area.
The document addresses considerations taken for different products and circumstances. For example, products that generally are subject to more extensive monitoring include: NDAs that are new molecular entities, original biological license applications, biosimilar biological products, first-in-class approvals, newly approved formulation(s), newly approved indication(s), extension into new patient populations, products with complex pharmacokinetic or pharmacodynamic characteristics, and products with complex compositions or manufacturing processes. FDA staff also monitor the safety of compounded products, even though they are not subject to FDA premarket review and approval, as well as homeopathic products.
“Our best practices document incorporates the guiding principle that postmarket safety surveillance is a dynamic and constantly evolving field,” read a statement for the agency. “By using a risk-based approach, the FDA takes into account the nature of the drug, its potential adverse events, the intended population, and the potential for serious outcomes, as well as the impact on individuals and the overall potential impact on the health of the public.”