FDA releases annual medicine quality report for 2020

The Office of Pharmaceutical Quality (OPQ), a department within the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) has released a report detailing the efforts it made in 2020 to ensure quality medicines are made available to the public.

The report’s four key themes are ‘Collaborate, Innovate, Communicate and Engage’. However, a constant topic throughout these themes was highlighting the challenges posed by the COVID-19 pandemic, and the efforts the OPQ took to ensure their work continued and their yearly goals were met despite it. The office’s assessment, inspection, research, surveillance and policy functions were all impacted by the pandemic. However, the use of alternative tools for manufacturing facility assessments led to 153 applications being approved without conducting on-site facility inspections.

The report also highlights how the OPQ worked to aid the public health response to the pandemic by conducting accelerated approvals and emergency use authorisations (EUA) for medicines used to treat COVID-19 patients. This stems from one of the core functions of the OPQ which is to conduct quality assessments for all types of human drug applications including investigational new drug applications (INDs), new drug applications (NDAs), abbreviated new drug applications (ANDAs) and biologics license applications (BLAs).

With supply chains disrupted by COVID-19, the OPQ worked to accelerate quality assessments and prevented 293 potential drug shortages, ensuring continued access to medicines despite the pandemic. Innovation is another way in which drug shortages were prevented. Working with other offices in the CDER, the OPQ hopes to increase use of advanced and continuous manufacturing techniques and stimulate the use of other innovative technologies. This will be one way to ensure drug availability despite quality concerns or during periods of sudden increased demand (such as during a pandemic).

Other developments noted in the report were the advancements in continuous manufacturing including the first applications to use the technique for an active pharmaceutical ingredient (API), the OPQ’s involvement in the CDER’s emerging technology program and an update on its Knowledge-aided Assessment & Structured Application (KASA) tool. Key milestones include over 10,000 approved quality-related changes for previously approved products, over 200 manufacturers participating in a global benchmarking study to characterise quality management and the approval of 942 generic drugs of which 159 were first generics, 2 were complex generics and 3 were biosimilars.

The report concludes with a segment on plans for 2021. The key focus will be on promoting manufacturing innovation and effective quality management in drug manufacturer’s facilities. Collaboration with international regulators and the International Council for Harmonisation (ICH) to develop manufacturing and quality guidelines will be another area of focus for the OPQ moving forward. Finally, the organisation aims to continue work on two internal initiatives on a Quality Management System and an Enterprise Risk Management strategy to identify and prepare for future challenges.

To read the full report, click here.