How FDA’s Division of Pharmacovigilance tracks drug safety and how to report adverse events

Lieutenant Commander Anne Tobenkin and Leah Herity of FDA’s Division of Pharmacovigilance outlined how the Center for Drug Evaluation and Research monitors and acts on postmarket drug safety concerns.

DPV’s work centers on identifying “safety signals” — new or worse adverse events that warrant follow-up. "Pharmacovigilance is the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects," Tobenkin said, describing CDER’s 2020 framework that separates signal work into pre-evaluation, evaluation and action phases.

The office relies on FAERS, regulatory partners, published literature and nontraditional sources such as social-media posts, poison-center records and consumer reviews to find potential signals. Tobenkin highlighted FAERS’ scale: FDA receives more than 2 million adverse event reports annually and maintains over 20 million total reports, and about 5% of reports come directly from patients, clinicians or consumers through MedWatch.

DPV prioritizes unexpected and serious events (including death, life-threatening outcomes, hospitalization or disability) and uses multidisciplinary evidence to assess causality — considering timing, dechallenge/rechallenge, dose–response, biological plausibility and confounding. When a concern meets the evidentiary threshold, actions can include label changes, Dear Healthcare Provider letters, drug safety communications, CDER safety alerts, postmarketing requirements or, in rare cases, market withdrawal.

The presenters also reviewed how to submit an adverse event report. "To transmit a report to FDA, there are only four required pieces of information: the patient, the product, the adverse event itself, and the reporter," Herity said, but they stressed that safety evaluators often need much more clinical detail (for example, timing, comorbidities, dechallenge/rechallenge and concomitant medications) to assess a possible causal link.

The session closed with four takeaways: DPV monitors approved and unapproved products; a wide range of data sources improves detection; there are multiple communication tools for disseminating findings; and consumer and clinician reports are essential for identifying unexpected serious events. The presenters invited questions from attendees.