FDA’s OPQ 2021 report focuses on pandemic responses
Onsite inspections will remain the “irreplaceable standard” and are not going away anytime soon, despite the heavy reliance on remote tools to assess medicine manufacturing facilities during the coronavirus pandemic, officials from the US Food and Drug Administration noted in their 2021 report on the Office of Pharmaceutical Quality (OPQ).The 2021 report focused on the FDA’s actions in responding to the pandemic, as did the report from 2020 (RELATED: FDA’s OPQ reports on drug quality efforts in 2020, Regulatory Focus, 11 February 2021.
“As the world continues to navigate the effects of the continuing COVID-19 public health emergency, pharmaceutical quality is perhaps more important than ever before,” according to the report.
OPQ expedited quality assessments of 343 submissions to avoid drug shortages and supported seven Emergency Use Authorizations (EUAs) for COVID-19 treatments in 2021. Of those, four were small molecule products and three were monoclonal antibody products.
To achieve its mission, FDA and OPQ relied heavily on alternative tools, such as leveraging Mutual Recognition Agreements; using information from document-based inspections; and/or employing confidential agreements with “trusted” regulators to assess manufacturing facilities.
The agency was able to reduce the number of facilities needing pre-approval inspections (PAIs) by over 50%, allowing OPQ to assess 269 drug product submissions using these tools in 2021.
Using these alternative tools also enabled the agency to approve 776 generic drugs, 108 new drugs and 20 new biologics and over 8,000 supplements.
“The tools leveraged and refined during the public health emergency will continue to be useful in the future, though inspections will remain the irreplaceable standard,” according to the report.
OPQ also detailed the progress being made in implementing its Knowledge-Aided Assessment and Structured Application (KASA) drug review program and Emerging Technology Program (ETP) from the Center for Drug Evaluation and Research (CDER).
“KASA now provides over 15 analytics reports to OPQ assessors across the drug substance, drug product, manufacturing, and biopharmaceutics disciplines,” OPQ wrote. “To further enhance assessment of efficiency and strengthen collaboration, OPQ assessors now conduct integrated quality assessments in aligned teams, which are smaller pools of experts from which teams are assigned to assess applications.”
FDA officials noted last year that the agency was taking a “step-wise” approach to implementing KASA, and that while the program has already launched for abbreviated new drug applications (ANDA) for solid oral dosage forms, it will eventually be rolled out for new drug applications (NDA) and ANDAs for liquid dosage forms in FY 2023, and phased in for investigational new drug applications (INDs) and post-approval changes in in FY 2024, with work on biologics license applications (BLAs) modules continuing in FY 2025. (RELATED: FDA taking incremental approach to launching KASA reviews, Regulatory Focus, 5 November 2021)
The OPQ report highlighted that more stakeholders have participated in ETP in 2021, engaging with FDA officials in advance of filing regulatory submissions to discuss technical and regulatory issues that may arise with new technologies. ETP also “graduated” its first technology in 2021, a continuous direct compression process for manufacturing tablets.
Pharmaceutical quality was stressed in the White House 100-Day Report, released in June 2021, that recommended establishing new production methodologies and creating a system to evaluate manufacturers’ quality efforts (RELATED: Biden administration outlines plan to address US supply chain vulnerabilities, Regulatory Focus, 8 June 2021).
OPQ annual report
