Going to 11: New Subsections at CDER’s Office of Pharmaceutical Quality Are Important Piece of FDA’s Inspection and Enforcement Strategy

November 20, 2023By John W.M. Claud

The word last week was that FDA is re-organizing the Office of Pharmaceutical Quality (OPQ) within the Center for Drug Evaluation and Research (CDER).  It is the latest item on a long list of similar initiatives that have marked 2023.  Those efforts add up to a clear message to industry that FDA is looking beyond CGMP when it evaluates drug makers. The Agency wants to see functional, effective cultures of quality, and expects that C-suites will provide support to quality units.

CDER Director Patrizia Cavazzoni first announced the upcoming changes at OPQ last week in an email to staff, which then went out to trade media. The restructuring divides OPQ into 11 sub-offices that FDA described as creating “a more streamlined, agile, and flexible organization. . . .” Only within the Federal bureaucracy can a (1) complex restructuring of (2) an office of (3) a Center into (4) eleven sub-units be described as “streamlining.” But to be sure, FDA is going beyond just making 10 louder. The Agency has high expectations of industry’s willingness to invest in and proactively address quality matters.

The new parts of OPQ reflect that. Of note, the new structure removes any separation between new and generic drug quality review offices. Under the new OPQ, quality is assessed without much concern of the relevant premarket approval process.

It’s also clear that culture counts. Cavazzoni told staff that the changes at OPQ will strengthen “connections between assessment, inspection, surveillance, research, policy, and administrative operations.” Under this enforcement assessment, quality affects everything. The changes at OPQ will take effect on January 14, 2024.

FDA is putting time and effort into quality systems because when they are lacking, numerous problems can follow, including drug shortages. The changes at OPQ are the latest in FDA’s expanded 2023 quality efforts. For example, in August, CDER and OPQ initiated the Quality Management Maturity Program (QMM) that aspires to “implement quality management practices that go beyond current good manufacturing practice (CGMP) requirements.” Quality agreements between manufacturers and third-party suppliers are on FDA’s radar, and the Agency has shown a willingness to delay approvals in the face of quality concerns. And we are seeing more and more warning letters that cite entire quality units for lacking qualifications and failing to execute their responsibilities.

FDA is putting resources into evaluating quality units across all types of manufacturing and is on the lookout for failures of quality cultures. We’ll almost certainly hear more about this as the Agency cements its organizational changes in 2024. Under this scrutiny, quality units are no places for free-form jazz odysseys.