Report Says Pandemic Hurt FDA’s Pharma Compliance Monitoring

The FDA’s ability to monitor drug facility compliance in fiscal year 2020 was significantly impacted by COVID-19, with only 745 inspections completed for the year vs. 1,367 in fiscal 2019.

The FDA also had to rely on mutual recognition agreements with other global regulators to perform 183 of those 2020 inspections, the Office of Pharmaceutical Quality (OPQ) said in its 2020 annual report, which covers the period Oct. 1, 2019, to Sept. 30, 2020.

The OPQ also noted that fewer drug facility warning letters were issued in fiscal 2020 than in fiscal 2019, reversing a five-year upward trend. The agency issued approximately 100 warning letters in 2019, but roughly 20 percent fewer in fiscal 2020.