The U.S. Food and Drug Administration (FDA) currently utilizes information from multiple sources to evaluate the safety of approved medical products. Active medical product surveillance is a new tool that will augment the Agency’s existing postmarket safety assessment process. Numerous issues make communicating active surveillance activities and associated findings challenging.
On November 17, the Engelberg Center for Health Care Reform hosted a one-day expert workshop to discuss issues pertaining to communication of medical product safety surveillance findings. Experts from both the private and public sectors discussed several topics including:
- Current statutory provisions and FDA activities regarding safety and risk communications;
- Stakeholder perspectives on and implications of active surveillance communication strategies (stakeholders included patients, consumers, health care providers, sponsors, data partners, payers, scientists, and media);
- Mechanisms for rapid communication that do not pre-empt journal publications with more complete analyses; and
- Strategies to educate patients, physicians, and other decision makers on how to interpret and apply active surveillance results.