FDA’s Office of Compliance Releases 2021 Annual Report

The Office of Compliance in FDA’s Center for Drug Evaluation and Research has released the office’s 2021 Annual Report. The report focuses on the various successes of the agency in public health throughout 2021.

The report highlights key initiatives that had a direct impact on patient safety, including efforts to address the COVID-19 pandemic. Other areas of focus include addressing the opioid crisis, compounded drug quality, drug supply chain security, fraudulent and unsafe drugs, amongst others throughout 2021.

The Office of Compliance’s efforts regarding COVID-19 included shielding patients and consumers from unsafe, ineffective, and poor-quality drugs, including unsafe hand sanitizers and products fraudulently claiming to prevent, treat, or cure COVID-19. The office also took action to increase access to critical medicines used to treat patients with COVID-19, such as albuterol, oxygen, and propofol, as well as support the development of new therapeutics.

The use of alternative tools used when on-site inspections were prevented due to COVID-19 was also described in the report, focusing on reorganization to strengthen oversight of drug compounding and prevention of fraudulent, poor quality, and unsafe drugs. The Office of Compliance makes strategic and risk-based decisions that are guided by law and science to foster global collaboration, promote voluntary compliance, and take decisive and swift actions to protect patients.

Source: FDA