FDA announces OPQ reorganization to alleviate ‘long-standing pain points’

The US Food and Drug Administration (FDA) recently announced a reorganization of its Office of Pharmaceutical Quality (OPQ) that aims to correct inefficiencies in its operation worsened by the COVID-19 pandemic. The reorganization was announced by Patrizia Cavazzoni, the director of FDA’s Center for Drug Evaluation (CDER) in an internal memo to staff.

“While the office has been addressing process inefficiencies for the past several years, OPQ leadership thoughtfully designed this new organization to mitigate long-standing pain points from the current structure, many of which were exacerbated by the pandemic,” Cavazzoni said in the memo.

The reorganization will go into effect on 14 January 2024.

Under the reorganization, the Office of New Products (ONDP), the Office of Lifecycle Drug Products (OLDP), and the assessment functions of the Office of Biotechnology Products (OPB) will be replaced by three new suboffices in a new Office of Pharmaceutical Quality Assessment (OPQA).

Two of the sub-offices -- OPQA I and II -- will oversee product assessment for small molecule products, while OPQA III will focus on drug substance assessment for large and small molecule products.

When asked about staffing for the new suboffices, FDA told Focus that almost all staff members will have the same job functions and “all employees will have opportunities to continue their development within OPQ.”

The reorganization also establishes a new Office of Quality Assurance (OQA), which will manage enterprise project management activities not related to reviewing drug applications.

Additionally, a new Office of Pharmaceutical Quality Research (OPQR) has been created to coordinate research within OPQ and manage laboratory-based resources. Laboratory staff from OBP and the Office of Testing and Research (OTR) will be shifted to this office, according to FDA.

“OPQ’s new organizational structure is designed to better align functions to support evolving, mission critical priorities, and enables future growth to meet anticipated public health needs. It will create a more streamlined, agile, and flexible organization focused on consistent processes, continuous improvement, and expansion of the expertise and capability of the current workforce,” FDA told Focus.

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)

In January 2015, former CDER director Janet Woodcock told Focus that chronic drug shortages and a lack of manufacturing modernization factored into FDA’s decision to create OPQ (RELATED: Leader Sought for FDA’s Powerful New Office of Pharmaceutical Quality, Regulatory Focus 2 April 2015).

Over its history, OPQ has aimed to address quality maturity and quality reviews, among other issues. The office launched a program to improve the quality maturity at companies under its quality management maturity (QMM) initiative, which aims to measure the strength of facilities’ quality practices. OPQ also launched a Knowledge-aided Assessment and Structured Application (KASA) drug review program as part of its effort to improve quality reviews of drug applications and speed products to market (RELATED: OPQ touts progress on quality management maturity, KASA in annual report, Regulatory Focus 16 February 2023).

FDA announces OPQ reorganization to alleviate ‘long-standing pain points’

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