OPQ’s 2023 Annual Report: an Upbeat Review of CDER’s Quality Efforts

April 8, 2024By John W.M. Claud

CDER’s Office of Pharmaceutical Quality (OPQ) issued its 2023 Annual Report last week, and it’s an upbeat assessment of the Office’s policy and outreach efforts. Last year, OPQ saved a more quantitative analysis of its efforts for the other yearly publication it put out, on the State of Pharmaceutical Quality. Again this year, the Annual Report that was released last week did not feature much in the way of specific quality issues. That said, there are certainly some important data to review.

This year’s report noted that CDER’s Drug Product Catalog contains over 140,000 entries, the same amount as OPQ listed in 2022. Readers also saw that that the Center’s manufacturing Site Catalog remains steady at more than 4,800 entries, the same number we found in the 2022 State of Pharmaceutical Quality report. Those numbers are the stars in the manufacturing universe that CDER uses to plot its regulatory course, so it’s of interest to see how they have remained consistent even if OPQ didn’t take the next step of connecting the points in those constellations.

OPQ also boasted that last year it performed quality assessments of more than 1,100 approved or tentatively approved applications. In a display of the competition within the generic industry that keeps margins low, this total included 118 new drug applications and 956 generic drug applications. OPQ also worked on 55 novel drug approvals for products with new molecules.

Drug shortages have been a scourge for FDA, both as they negatively affect consumers and FDA’s reputation. The report stated that OPQ performed 359 expedited quality assessments to address shortages. Unfortunately, it is also unencumbered by any explanation about what those expedited reviews looked like, or, for example, how OPQ coordinates with CDER’s Drug Shortage Staff. From that lack of detail, it would appear that FDA thinks of Good Manufacturing Practice (cGMP) compliance as a timeless and ecumenical pursuit, following the well-worn path laid out in its now-18 year old guidance.

The role of technology on quality was another feature. The report highlighted CDER’s Framework for Regulatory Advanced Manufacturing Evaluation Initiative and OPQ’s own Emerging Technology Program. It also noted that last year, FDA hosted a two-day public workshop and published a white paper on the regulatory framework for Artificial Intelligence in drug manufacturing, in addition to other efforts. Like many of us, OPQ seems intent on trying to keep up with how technology can/will impact pharmaceutical quality.

There was also a nod to something we blogged about last year, OPQ’s recent reorganization. Now complete, the Office thinks the re-org will allow it “to adapt to the changing pharmaceutical landscape by being more agile and efficient.” Under the new structure, quality is assessed without concern for the relevant premarket approval process. The new sub-offices are organized to review drugs by type, not by approval route. This strikes us as another signal that FDA sees the policies of cGMP as evergreen, and largely immune to even seismic technology shifts.

OPQ plays such a vital role in the cGMP and drug quality space, we’re always happy to read about its policy and outreach efforts. But here’s also hoping that we’ll see some more detailed data in an upcoming missive on the industry-wide state of quality.