FDA’s OPQ reports on drug quality efforts in 2020

| 11 February 2021 |  By 

The office tasked with overseeing pharmaceutical quality within the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) released its annual report for 2020 on Thursday, highlighting its effort in a year marked by the COVID-19 pandemic.
In its previous annual report, the Office of Pharmaceutical Quality (OPQ) touted its participation in nearly one third of the preapproval inspections FDA carried out in 2019. For 2020, OPQ instead focused on the fact that it was able to make use of alternative tools to bypass the need for 153 on-site facility inspections, as the agency was forced to halt all but mission critical inspections last March. (RELATED: FDA’s OPQ, OCP tout 2019 highlights in new reports, Regulatory Focus 10 February 2020; Inspections: GAO calls on FDA to plan for backlog, review alternatives, Regulatory Focus 1 February 2021).
As has been previously reported for CDER, OPQ stressed that more than 95% of applications subject to user fee goals were acted on by their goal date. OPQ performs a quality assessment 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). The office is also tasked with overseeing the quality of compounded and over-the-counter drugs. (RELATED: Inspections down in 2020, but CDER hit most goal dates, Regulatory Focus 26 January 2021).
In 2020, OPQ said it enabled the approval of 942 generic drugs, 72 of which were first generics and two were complex generics, as well as three biosimilars. The office also said it approved more than 10,000 quality-related changes for previously approved products during the year.
The COVID-19 pandemic heightened concerns over drug shortages, leading to legislative action under the Coronavirus Aid, Relief and Economic Security Act (CARES Act). While FDA has yet to issue guidance on those shortage-related provisions or begin collecting data on the amounts of drugs manufactured, OPQ said it expedited quality assessments to head off 293 potential drug shortages in 2020. (RELATED: FDA delays collection of drug manufacturing volume data, Regulatory Focus 26 August 2020).
OPQ also highlighted its role in CDER’s emerging technology program, which enables early engagement with companies to promote the use of advanced manufacturing technologies. OPQ said the program received nine regulatory submissions, accepted 16 proposals and held 40 industry meetings in 2020.
Last year saw additional advancements in the use of continuous manufacturing. According to OPQ, the first applications to use continuous manufacturing for an active pharmaceutical ingredient (API) and to use continuous biomanufacturing were approved in 2020. Semi-continuous manufacturing processes were approved for two other products. (RELATED: Continuous manufacturing: FDA drafts quality guidance, Regulatory Focus 26 February 2019; FDA touts advanced manufacturing to address COVID shortfalls, Regulatory Focus 4 August 2020).
OPQ also gave an update on its knowledge-aided assessment & structured application (KASA) tool, which the office piloted in 2019. “In 2020, OPQ developed and tested new knowledge-aided assessment interfaces for drug substance information and liquid dosage form ANDAs. We also started to develop interfaces for INDs and BLAs. In early 2021, OPQ will begin using knowledge-aided assessment interfaces for solid oral dosage forms, manufacturing, and biopharmaceuticals,” OPQ said, noting that the structured application element of KASA is still being developed. “FDA use of KASA is expected to be a win for the FDA, applicants, and patients: more regulatory efficiency, increased consistency between submissions, and faster availability of quality products.” (RELATED: FDA explains plans for new pharmaceutical quality assessment system, Regulatory Focus 16 September 2019).
Additionally, OPQ touched on its efforts to put forward a framework for advancing quality management practices. One of the steps the office took in 2020 was to fund a study to establish a global baseline for pharmaceutical quality management practices that was conducted by consulting firm Dun & Bradstreet and the University of St. Gallen in Switzerland.
“Over 200 pharmaceutical manufacturing establishments around the globe participated in this free assessment and each will receive a custom benchmarking report with clearly identified opportunities for continual improvement,” OPQ said. (RELATED: CDER launches quality management maturity pilots for APIs and finished dosage forms, Regulatory Focus 16 October 2020).
Looking forward to 2021, OPQ said it will, “Focus on promoting manufacturing innovation and incentivizing manufacturers to strive for mature quality management at their facilities.” The office also said it will continue to engage with the International Council for Harmonisation on guidelines for continuous manufacturing, analytical procedure validation and development, as well as viral safety for biotechnology products. Internally, OQP said it will continue its effort to integrate a quality management system and develop an enterprise risk management strategy to help it assess and prepare for future risks.

Editor's note: This article has been updated to correct the number of first generics approved in 2020.


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Tags: drugs, FDA, OPQ, quality, US

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