Each year, the Office of Pharmaceutical Quality (OPQ) releases a report on the state of pharmaceutical quality. This year’s report was released yesterday and can be found here. Every year we try to pick out key issues and highlight some of the statistics outlined in the report, and this year is no different!

Some important facts include:

  • There are 4,819 manufacturing sites globally that the FDA has oversight over (referred to as the “Site Catalog”). About 42% of the sites are in the U.S. The total number represents a 14% increase over the past five years.
  • Of the 4,819 sites, 40% are in the “no applications sector” (meaning they produce either OTC monograph products or homeopathic drugs, or they market new drugs not approved by the FDA).
  • The FDA conducted “776 drug quality assurance inspections, over 40% more than the 548 accomplished in FY2022.”
  • The top five countries with manufacturing facilities that supply the U.S. market and are covered by the OPQ will come as no surprise, with the U.S. claiming the top spot (2,009), then India (585), China (484), Germany (195), and Italy (151). There is an interesting chart in the report that illustrates the growth in the number of facilities by country over the five-year period from FY 2019 to FY 2023. It is noteworthy that only Canada and the UK have had a decrease in the number of sites (4% and 1%, respectively) over the past five years.
  • The number of inspections classified under Mutual Recognition Agreements (MRAs) increased from 144 in FY 2022 to 187 in FY 2023, the highest number to date. This demonstrates an increased reliance on foreign inspectorates, upon which compliance decisions by the FDA are based. The decrease in redundant inspectional work is a big boon to the U.S. as it allows more efficient use of the limited Agency resources and it is also a benefit to industry as it means that sites do not have to utilize their resources to support multiple inspections, by different regulatory authorities, that are repetitive in scope.
  • In 2023, 25% of the India facilities in the site catalog were inspected, while only 6% of the facilities in China were inspected. The OPQ indicates that “[f]or India, the higher inspectional coverage of sites in the Site Catalog was driven by for-cause inspections, while for China, travel restrictions continued for almost all of FY2023, delaying inspections.”
  • “At the end of FY2023, CDER’s Product Catalog contained 17,519 application products (16,698 in FY2022) and 131,367 non-application product National Drug Codes (NDCs) (123,532 in FY2022).” That represents a lot of products and product SKUs for which quality metrics need to be evaluated, and this keeps the OPQ and the inspectorate quite busy.
  • During FY2023, CDER received 12,549 quality-related MedWatch (MW) reports (a 1.6% increase from FY 2022), 3,792 Field Alert Reports (FARs) (8.3% increase from FY 2022), 347 Biological Product Deviation Reports (BPDRs) (77% increase from FY 2022), and 398 quality-related Consumer Complaints (CCs) (53.7% increase from FY2022). Does this mean that quality is slipping at pharmaceutical companies, or is the volume of approvals and introduction of new products to blame? Hard to tell, but the report details why some of the increases might have occurred and links some specific product events (e.g., recalls of a number of ophthalmic products that experienced quality issues).
  • “There were more drug quality-related import alert additions in FY2023 (93) than during FY2021 and FY2022 combined (77).” According to the report, this increase was partially associated with hand sanitizer manufacturing issues.
  • “In FY 2023, there were 674 drug products recalled, down 26% from the high of 912 in FY 2022. The FY 2023 recalls were from 158 sites that generated 225 recall events.” During FY 2023, 35% of recalled products were associated with five specific events that are further outlined in the report.
  • In FY 2023, the FDA issued 94 warning letters to drug manufacturing sites for reasons related to drug quality.

The report goes on to discuss drug shortage issues and the part that the OPQ played in resolving many of the shortages, but still it appears that the FDA’s view of drug shortages is somewhat different than the view of industry and patients (as discussed in a previous post here). The report also touches on drug sampling that the OPQ/FDA performs and several other top-line issues. All-in-all, the OPQ is very busy ensuring the quality of the drug supply and the compliance of the pharmaceutical industry through its numerous responsibilities and activities. Please take a look at the report to appreciate both the volume and importance of work that the OPQ undertakes.