OPQ Issues the 2019 Report on the State of Pharmaceutical Quality

The Office of Pharmaceutical Quality (OPQ) within the Food and Drug Administration’s (FDA’s) Center for Drug Evaluation and Research has published its 2019 Report on the State of Pharmaceutical Quality. The report for fiscal year 2019, October 1, 2018 to September 30, 2019, contains select quality indicators and trends that provide insight into the quality of the U.S. drug supply chain. This report is a summary of various measures of the pharmaceutical manufacturing industry’s ability to deliver quality drug products to U.S. patients and consumers.

The FDA uses this report to inform regulatory decision-making and surveillance activities. This information is publicly available for external stakeholders to better understand the quality of the U.S. human drug supply. Additionally, this information is used to identify better ways to engage the pharmaceutical manufacturing industry and drive industry improvements, which are essential to furthering the global commitment to quality. This report is one example of work that OPQ conducts in support of our public health mission to assure patients and consumers have access to safe, effective, quality medicines.

OPQ has a unique role at the FDA, working on activities that impact all human drug user fee programs: new drugs, generics, and biologics – including biosimilars. OPQ has the same expectations for quality for all classes of drugs whether made in the U.S. or abroad.

While much has happened to impact the state of pharmaceutical quality since the end of fiscal year 2019, most observations remain relevant. Newer events related to COVID-19 and the recalls of certain metformin drug products will be covered in next year’s report.