COVID-19 Pandemic Cripples FDA’s Drug-Manufacturing Inspections

Among the most critical tools used by the Food and Drug Administration (FDA) to ensure the safety and quality of medications are on-site inspections of pharmaceutical manufacturing facilities. But according to a troubling report issued in January by the Government Accountability Office (GAO) — an independent, nonpartisan federal watchdog agency that works for Congress[1] — the COVID-19 pandemic has caused severe reductions in the FDA’s entire inspection program, with inspections of foreign drugmakers brought to a virtual standstill.[2]

The FDA normally inspects manufacturing facilities before a new drug is approved, periodically after approval as part of routine surveillance, and in response to complaints or indications of manufacturing problems. The goals of these inspections are to ensure that companies consistently make drug products of acceptable quality and minimize consumers’ exposure to “adulterated” or tainted medications.[3]

The GAO reported that prior to the pandemic, the FDA typically conducted more than 1,600 inspections of domestic and foreign drug manufacturing facilities annually. In March 2020, the FDA postponed most inspections because of COVID-19. Domestic inspections resumed in the summer, but at a reduced rate. The GAO found that from early March to Oct. 1, 2020, the FDA conducted only 52 inspections of U.S. manufacturing facilities, compared with about 400 inspections conducted during the same period in 2018 and 2019 (a more than 85% reduction).

The impact of COVID-19 on foreign inspections was even more dramatic. In early March 2020, citing the safety of its employees, the FDA announced that it would only conduct foreign inspections that were deemed “mission critical.” The GAO found that from early March to Oct. 1, 2020, the FDA conducted only three mission-critical inspections of foreign manufacturing facilities. By comparison, the FDA conducted more than 600 foreign inspections during the same period in 2018 and 2019.

The GAO noted that as of August 2020, nearly 60% of the 4,200 facilities that manufactured medicines for the U.S. market were located in other countries. More than one-third of these foreign facilities were located in China and India.

The FDA has relied temporarily on other tools to try to oversee drug manufacturing, such as reviewing results of inspections conducted by foreign regulatory agencies, requesting records to review and conducting sampling and testing of medications. However, in the long term, these alternatives are not an adequate or comprehensive substitute for on-site FDA inspections. For example, records can be falsified or destroyed to cover up serious deficiencies.

The FDA must ramp up on-site inspections of drug manufacturing facilities — particularly in foreign countries — as soon as possible. To deal with the enormous inspection backlog, the agency quickly must hire and train additional inspectors and ensure they receive COVID-19 vaccinations so that these staff can resume inspections safely.
 

References

[1] U.S. Government Accountability Office. About GAO. https://www.gao.gov/about/. Accessed February 5, 2021.

[2] U.S. Government Accountability Office. COVID-19: Critical Vaccine Distribution, Supply Chain, Program Integrity, and Other Challenges Require Focused Federal Attention. January 2021. https://www.gao.gov/assets/720/712030.pdf. Accessed February 5, 2021.

[3] Food and Drug Administration. Compliance program: Chapter 56: Drug quality assurance. October 31, 2017. https://www.fda.gov/media/75167/download. Accessed February 5, 2021.