FDA’s CDER Issues FY2023 Annual Report

by Mark Gardner

In January 2024, the Office of Compliance at the FDA’s Center for Drug Evaluation Research (CDER) released its Annual Report for FY2023. The Annual Report contains several useful pieces of information for drug companies and pharmacies, including insights into the Office of Compliance’s current enforcement priorities.

These enforcement priorities include Clinical Trial Oversight and Bioresearch Monitoring, Drug Compounding Compliance, Assessing Drug Supply Chain Risks, and Drug Manufacturing Compliance.

Clinical Trial Oversight and Bioresearch Monitoring

The Office of Compliance’s FY2023 Annual Report highlights its recent enforcement efforts in the areas of clinical trial oversight and bioresearch monitoring. While implementing various new pilot programs and assessment tools, the Office of Compliance issued eleven warning letters – six to clinical investigators, four to sponsor-investigators, and one to an Institutional Review Board (IRB) – in FY2023.

Addressing Drug Supply Chain Risks

The Annual Report also highlights the Office of Compliance’s efforts to enforce the Drug Supply Chain Security Act (DSCSA) over the past fiscal year. These efforts include requesting and ordering recalls, issuing warning letters, and ramping up its efforts to oversee drug-related imports. Protecting the drug supply chain is a persistent priority for the FDA (and other federal authorities) as well, so this is also likely to remain an active area for enforcement in 2024.

Drug Manufacturing Compliance

In its FY2023 Annual Report, the Office of Compliance highlights several efforts to enforce drug manufacturers’ compliance obligations. It also identifies the most common citations in warning letters issued in connection with Current Good Manufacturing Practice (CGMP) violations. These were:

• Responsibilities of a Quality Control Unit (21 CFR 211.22) – 48 warning letters

• Control and Testing of Components, Containers, and Closures (21 CFR 211.84) – 47 warning letters

• Written Procedures; Deviations (21 CFR 211.100) – 30 warning letters

• Production Record Review (21 CFR 211.192) – 16 warning letters

• Equipment Cleaning and Maintenance (21 CFR 211.67) – 9 warning letters

Here, too, the scope and breadth of the Office of Compliance’s enforcement efforts indicates that this is a significant focus. With this in mind, as we move through 2024, drug manufacturers should invest the time and effort necessary to ensure that their operations are fully CGMP compliant.

Drug Compounding Compliance

As the Annual Report explains, over the past decade, the FDA has “released more than 60 policy documents, including 27 final guidance documents and three final rules,” related to drug compounding. While many of these efforts have targeted specific compliance concerns within the compounding field, the scope of the FDA’s efforts in this area make clear that compounding compliance broadly is a persevering concern for the FDA and CDER’s Office of Compliance. The Annual Report also notes that the Office of Compliance sent 11 warning letters related to drug compounding in FY 2023—further underscoring the importance of compliance in 2024.

Conclusion

The CDER Office of Compliance FY2023 Annual Report provides some key insights into the FDA’s ongoing enforcement priorities. Drug companies and pharmacies should use these insights when developing their 2024 compliance strategies, keeping in mind that these are far from the only areas where noncompliance can lead to FDA inspections and enforcement.

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