FDA Faces Huge Task Catching Up On Inspections

FDA quietly announced last week that it was resuming domestic surveillance inspections for drugs and other regulated products after another hiatus due to the pandemic. Regular FDA field inspections have been halted several times since March 2020, most recently at the end of 2021; the spread of the omicron variant boosted COVID-19 infections, raising fears that FDA inspectors as well as local plant personnel could be exposed to the virus from such interactions.

Now FDA has determined that new infections are declining sufficiently to restart more routine site visits.¹ FDA’s Office of Regulatory Affairs (ORA) had continued to conduct “mission-critical” inspections, both foreign and domestic, during these inspection shutdowns, but the numbers were low. Now the task of catching up is considerable, with some 8,000 site inspections of drug manufacturing facilities postponed during the height of the pandemic, and many more since then.

For foreign inspections, FDA aims to start conducting prioritized site visits in April. Agency inspectors will go to locations that have received “country clearance” and meet the Level 1 or Level 2 travel recommendations from the Centers for Disease Control and Prevention (CDC).

For both US and foreign facilities, the agency will continue to provide “effective oversight” of foods, drugs, medical products and tobacco through remote assessments and by utilizing “a variety of tools.” This includes more extensive analytical testing and sampling of drugs, particularly at US borders. FDA also is requesting documents from facilities to review compliance histories off-site and plans to continue visiting plants via video livestreaming.

More foreign inspections?

Even before the pandemic forced a halt to most FDA inspections, the scope and effectiveness of the agency’s drug inspection program was under scrutiny by federal watchdogs. Members of Congress and domestic manufacturers have long complained that infrequent and pre-announced foreign inspections fail to ensure that drugs made overseas meet the high quality standards required for products made in the US and create an uneven playing field between US and foreign firms. The issue has been assessed regularly by the Government Accountability Office (GAO), and a new report provides additional advice on how FDA should improve the program.²

GAO has found that FDA succeeded in increasing foreign inspections in 2019, as the analysts had advised. However, the COVID-19 pandemic halted almost all that activity; FDA conducted only three foreign inspections in most of 2020, and 18 high priority inspections through April 2021, compared to some 600 foreign inspections in previous years. Now GAO is looking for FDA to assess whether some of the inequities between foreign and domestic inspections can be addressed by conducting unannounced foreign site visits and by utilizing independent translation services, as opposed to relying on translators engaged by the host site. GAO notes that sound methods are needed for evaluating the results of these pilot programs in order for FDA to be able to determine if such approaches can be applied more effectively to its broader inspection program.

GAO also continues to emphasize the need for FDA to fill the many “persistent” vacancies in its inspection workforce, particularly personnel specializing in foreign inspections. Staff shortages are serious for both FDA’s US-based foreign inspection cadre as well as in overseas offices in China and India.

It’s no news that throughout its operations, FDA has many unfilled positions and that recruiting is a major challenge for both foreign and domestic inspection work. Agency officials also have long recognized the drawbacks of pre-announced inspections, as well as the complexities in planning, supporting and carrying out unannounced foreign site visits. The goal of creating a more “level playing field” between US and foreign manufacturers is important, but will remain a clear challenge for some time to come.

References

1. https://www.fda.gov/news-events/press-announcements/fda-roundup-february-4-2022
2. https://www.gao.gov/assets/gao-22-103611.pdf