The US Food and Drug Administration (FDA) has finalized a guidance describing best practices for its staff in conducting postmarketing safety surveillance of marketed drug and biological products.
This document was published under a mandate of the 21st Century Cures Act, which required FDA to publish these best practices on its website. The document replaces a previous requirement under the Food and Drug Administration Amendments of 2007 (FDAAA) that FDA prepare a safety summary analyses of the adverse drug reports received for a drug by 18 months after approval or after use of the drug in 10,000 individuals, whichever is later.
The agency “determined these summary analyses were largely redundant to the surveillance practices in place at the time FDAAA took effect and were not an efficient use of FDA resources.” In place of the summary analyses, the Cures Act requires FDA make guidelines for best practices for drug safety surveillance activities publicly available on its website.
This document finalizes the draft document issued in November 2019.
The guidance specifies that products are grouped into three categories for adverse event screening:
• Category A: Reviewers should screen on a weekly basis newly received individual case safety reports (ICSRs) for products approved within the last three years; these products include: new molecular entities (NMEs), originator biological products; and products without NME designation but having a newly approved dosage form, route of administration, indication, or patient population with increased safety concerns.
• Category B: Reviewers should generally screen on a weekly basis newly received ICSRs and the medical literature for homeopathic and compounded products.
• Category C: Reviewers should generally screen on a weekly basis newly received ICSRs that report adverse events for any product in category A that is beyond 3 years postapproval, nonprescription drugs; and any product not in category A or B. In addition, reviewers should generally perform data mining at least yearly for category C products.
Some changes from the draft to the final document include:
• Clarifying the differences between an adverse event and adverse reaction;
• Clarifying which products are subject to more extensive monitoring;
• Adding a new description of the FDA Adverse Event Reporting System public dashboard;
• Revising the section on medication errors;
• Revising the section on the pregnant population to align with recently issued documents on clinical trials and postapproval pregnancy safety studies;
• New citations referencing the Sentinel system; and
• Including a reference to the Center for Drug Evaluation and Research’s Manual of Policies and Procedures for Collaborative Identification, Evaluation, and Resolution of a Newly Identified Safety Signal.
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