The omnibus spending bill recently signed by President Joe Biden directs the FDA to expand unannounced foreign facility inspections and evaluate them through a new pilot program.
The legislation includes $10 million for the program and a mandate to increase unannounced surveillance inspections of foreign drug establishments, Regulatory Focus reports.
The legislation also directs the FDA to evaluate “the differences between such inspections of domestic and foreign human drug establishments, including the impact of announcing inspections to persons who own or operate foreign human drug establishments in advance of an inspection.”
More specifically, the pilot program will evaluate significant differences between announced and unannounced inspections of foreign drug facilities, with a particular focus on differences in the number and type of violations of the Federal Food, Drug, and Cosmetic Act.
The pilot program will also evaluate, per the legislation:
- “Costs and benefits associated with conducting announced and unannounced inspections of foreign human drug establishments;”
- “Barriers to conducting unannounced inspections of foreign human drug establishments and any challenges to achieving parity between domestic and foreign human drug establishment inspections;”
- “And approaches for mitigating any negative effects of conducting announced inspections of foreign human drug establishments.”
The legislation gives the FDA 180 days to launch the pilot and another 180 days after the program’s conclusion to send a final report to Congress. That report will include the agency’s findings on the topics of evaluation above, “including any recommendations to address identified barriers to conducting unannounced inspections of foreign human drug establishments.”
The report will also include findings and recommendations on how to achieve parity between domestic and foreign human drug inspections. Finally, the report will tally the number of unannounced inspections that would have been announced if not for the pilot program.
Law firm Akin Gump this week offered a rundown of the notable FDA changes from the legislation, including the Food and Drug Omnibus Reform Act (FDORA).
“This legislation represents the culmination of the user fee reauthorization legislative process for the prescription drug, medical device, generic drug and biosimilar user fee programs,” the law firm said in its analysis. “The stage is now set for FDA to implement these provisions, some of which require rulemaking, guidance or other agency actions. Despite the scope of this legislation, numerous significant policy issues were not addressed, and will potentially be considered by Congress in 2023 and beyond.”