The FDA’s Office of Pharmaceutical Quality (OPQ) recently published a report on the current state of pharmaceutical quality. However, there are some concerns and gaps in the report’s information.
The creation of OPQ was aimed at addressing the lack of quality-related information available outside of the product review process and post-approval inspections. The office aims to provide insight on quality throughout the lifecycle of products, including new drugs, generics, and over-the-counter medications.
One initiative established by OPQ is the Quality Management Maturity (QMM) program, which aims to improve product and process capability and reduce product shortages caused by quality-related issues. Another initiative is the Knowledge Aided Assessment and Structured Application (KASA) program, which aims to move from unstructured data to structured data for better knowledge management.
OPQ produces two major reports annually: an annual report and a pharmaceutical quality report. The recently published FY 2022 report on the State of Pharmaceutical Quality highlights the New Inspection Protocol Project (NIPP), QMM, and the CARES Act Drug Amount Reporting Program as the top priorities for OPQ in that fiscal year.
However, the report has some limitations. OPQ is still relatively new, and it is still determining the data points to collect and how sponsors should submit that information. Moreover, changes in metrics and data pooling make it challenging to compare the state of quality year to year.
The report also addresses manufacturing site demographics. While the number of manufacturing sites in the US has increased, other countries, such as India and China, have seen even more significant growth. The US’s market share of manufacturing facilities is slowly eroding, indicating a reliance on foreign manufacturers for essential medicines.
The report also discusses product quality defects. The FDA monitors product quality through mandatory reports from sponsors and voluntary complaints from consumers, patients, and healthcare professionals. The number of MedWatch complaints increased slightly, while consumer complaints decreased. The number of Field Alert Reports, which report significant quality problems, and Biological Product Deviation Reports, which report manufacturing deviations, also decreased.
In conclusion, while the report provides some insights into the state of pharmaceutical quality, there are concerns about the limited view it provides and the changes in metrics and data pooling. The report also highlights the reliance on foreign manufacturers for essential medicines and the decrease in product quality defect reports.
