A Few Thoughts on What FDA's OPQ Re-Org Could Mean for Industry
The FDA recently announced a reorganization of its OPQ that aims to correct inefficiencies in its operation worsened by the pandemic. Here's what teams should be thinking about.
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As reported in RAPS, The FDA is reorganizing its Office of Pharmaceutical Quality (OPQ) to address inefficiencies worsened by the pandemic.
The reorganization will replace the ONDP, OLDP, and assessment functions of the OPB with new suboffices under a new Office of Pharmaceutical Quality Assessment (OPQA).
The agency says its new structure will create a more streamlined, agile, and flexible organization focused on consistent processes, continuous improvement, and expansion of the expertise of the current workforce.
The reorganization will take effect on January 14, 2024.
Industry teams in pharma, especially those who interface with OPQ, are no doubt wondering what these changes will mean and how they should act accordingly. We’ve penned a few of our thoughts below under a short summary of the key details we know about this re-org.
What’s happening—at a glance
Issues like chronic drug shortages and lack of manufacturing modernization influenced the creation of OPQ in 2015. Since then, the office has focused on quality maturity, quality reviews, and initiatives like the Quality Management Maturity (QMM) and Knowledge-aided Assessment and Structured Application (KASA) programs.
This new reorganization will replace the Office of New Products (ONDP), the Office of Lifecycle Drug Products (OLDP), and the assessment functions of the Office of Biotechnology Products (OPB) with three new suboffices under the Office of Pharmaceutical Quality Assessment (OPQA).
OPQA I and II will focus on small-molecule products, while OPQA III will handle drug substance assessment for both large and small-molecule products.
In total, under the reorganization, there will be 11 suboffices within OPQ:
Office of Pharmaceutical Quality Immediate Office (IO)
Office of Administrative Operations (OAO)
Office of Pharmaceutical Manufacturing Assessment (OPMA)
Office of Policy for Pharmaceutical Quality (OPPQ)
Office of Product Quality Assessment I (OPQA I)
Office of Product Quality Assessment II (OPQA II)
Office of Product Quality Assessment III (OPQA III)
Office of Pharmaceutical Quality Research (OPQR)
Office of Program and Regulatory Operations (OPRO)
Office of Quality Assurance (OQA)
Office of Quality Surveillance (OQS)
The FDA indicated that most staff members will retain similar job functions, with opportunities for development within OPQ.
The reorganization introduces the Office of Quality Assurance (OQA) for managing non-review-related project management activities and the Office of Pharmaceutical Quality Research (OPQR) for coordinating research and managing laboratory resources.
We see a few potential implications of this re-org:
A potentially streamlined drug approval process. Thinking optimistically, the reorganization could lead to a more streamlined and efficient drug approval process. This might result in shorter review times and faster market access for new pharm products, benefiting both manufacturers and patients.
Increased emphasis on quality and safety. With dedicated offices focusing on quality assurance and research, there's likely to be a heightened emphasis on the safety and quality of pharmaceutical products. We could see stricter standards, more specialized and numerous regulatory staff, and more rigorous testing protocols.
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