Ensuring the quality of pharmaceutical products is essential and is part of the mission of the U.S. Food and Drug Administration (FDA). When pharmaceutical products do not meet quality standards, patients can be harmed or drug shortages can arise. Stakeholders, including patients, providers, pharmacists, drug purchasers, and payers, may each consider quality when making decisions about pharmaceuticals; however, very little research explores the role of quality in stakeholder decision-making.
This half-day public meeting, convened under a cooperative agreement between the Robert J. Margolis, MD, Center for Health Policy at Duke University in partnership with the FDA, will provide an opportunity to explore and better understand how stakeholders perceive and value the quality of pharmaceutical products. Key FDA leadership and staff will provide comments on the Agency’s current thinking and there will be opportunities for attendees to ask questions and engage with panelists. Topics for discussion include:
- The importance of pharmaceutical quality;
- The current state of pharmaceutical quality;
- FDA’s role in regulating quality; and,
- Stakeholder perceptions of pharmaceutical quality.
Funding for this meeting was made possible in part by a grant from the U.S. Food and Drug Administration. The views expressed in written conference materials or publications and by speakers and moderators do not necessarily reflect the official policies of the U.S. Food and Drug Administration nor does mention of trade names, commercial practices, or organizations imply endorsements.