FDA reports on drug quality, oversight trends in FY2019
In a new report, the US Food and Drug Administration’s (FDA) Office of Pharmaceutical Quality (OPQ) provides insights into the agency’s quality oversight of drugs and biologics intended for the US market.(RELATED: OPQ reports on state of drug quality in FY2018, Regulatory Focus 14 May 2019).
Manufacturer demographics
In FY2019, FDA saw an 8.6% decrease in the number of drug manufacturing sites in its catalog, from 4,676 in FY2018 to 4,273, despite the addition of 382 new sites.
FDA says the decrease is largely due to a drop in sites that manufacture “no application” products, such as over-the-counter (OTC) drugs and homeopathic products. FDA also notes a decrease in registered sites that only perform packaging and labeling operations.
“These decreases in site counts may be indicative of industry trends toward consolidation and/or the result of the FDA’s increasing efforts to more accurately curate facilities in the US drug supply chain,” FDA writes.
Of the sites in FDA’s catalog in FY2019, 1,793 (42%) were located in the US, 858 (20%) in the EU, 505 (12%) in India and 379 (8%) in China.
Inspections and compliance
FDA says its investigators performed 1,258 drug quality surveillance inspections in FY2019, a drop from the 1,346 conducted in FY2018.
However, FDA says it was able to review 109 drug quality inspections carried out by EU authorities under its good manufacturing practice (GMP) inspection mutual recognition agreement (MRA). In a separate report released in February, OPQ said it was able to reduce the number of routine surveillance inspections it carries out in the EU by 25% in 2019 because of the MRA. (RELATED: US and EU fully implement mutual agreement on GMP inspections, Regulatory Focus 12 July 2019; FDA’s OPQ, OCP tout 2019 highlights in new reports, Regulatory Focus 10 February 2020).
Including the inspections carried out by EU investigators, 58% of inspections were for facilities located outside the US. “The collective inspections by FDA investigators and EU investigators under the MRA provided coverage of 32% of the total global site catalog in FY2019,” FDA writes.
FDA also notes that from FY2017-FY2019, it was able to decrease the number of inspections in the US and EU and increase its inspection efforts in India, China and the rest of the world.
Based on its 10-point inspection score, FDA says the overall average for inspections in FY2019 was 7.4, with average scores for US- and EU-based sites being slightly higher than the rest of the world, at 7.7 and 7.6, respectively. Scores in other parts of the world were lower, with an average score of 7.0 for facilities in China and 6.8 in both India and across Latin America.
The report notes that sites in the “no application” category bring down the global average, with homeopathic products and sterile over-the-counter (OTC) products having the lowest average scores at 6.5 and 6.2, respectively.
Looking at inspection findings, FDA says that just three categories accounted for more than half (58%) of all observations: records and reports (23.9%), laboratory controls (19.3%) and equipment (14.8%). The next two biggest categories for observations were organization and personnel (13.6%) and production and process controls (12.4%).
FDA also lists the three most commonly cited CFR subparts: 21 CFR 211.192, production record review (8%); 21 CFR 211.22, responsibilities of the quality unit (8%); and 21 CFR 211.160, general requirements/scientifically sound laboratory controls (5%).
The report notes a sharp uptick in the number of noncompliant samples it observed in FY2019 for cardiovascular drugs and a slight increase in the noncompliant samples of dermatological and gastrointestinal drugs. These increases are largely attributed to the agency’s response to the detection of nitrosamine impurities in angiotensin II receptor blockers (ARBs) and ranitidine.