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Congress questions FDA on plans to catch up and move forward with facility inspections.
As the global COVID-19 pandemic passes the 18-month mark, there are signs that some businesses are resuming pre-pandemic operations. Answers to the “when can I …” questions about returning to the office, school, vacation, indoor activities vary based on region and vaccination status. On the bio/pharmaceutical front lines, drug companies and Congress are asking FDA: When will inspections resume?
In March 2020, travel restrictions prompted FDA to put inspections on hold and conduct only mission-critical inspections and focusing on efforts to prevent drug shortages and bring pandemic-related vaccines treatments to market. From March 2020 to March 2021, application decisions of 48 human drugs—including six deemed “mission critical” and nine animal drugs were delayed because inspections were not conducted. As of March 2021, the agency had a backlog of approximately 1000 inspections for human and animal drug facilities to tackle (1).
In a six-page letter dated July 22, 2021, members of the House Energy and Commerce Committee sought details about foreign inspections; if delayed inspections are slowing the approval of applications for new drugs, generics, and biosimilars; if FDA is using inspection reports from trusted inspectorates; and how will FDA’s data modernization plan impact inspection activities. In addition, the committee asked how the $38.3 million provided to FDA to address the pandemic has been used to resume domestic and foreign inspections (2).
Acting FDA Commissioner Janet Woodcock outlined the Agency’s plans in testimony before the Senate Health, Education, Labor and Pensions Committee on July 20, 2021 (3). FDA has established an Inspectional Affairs Council to coordinate inspection approaches and assessments across product centers and will review the number of COVID-19 cases in different regions to assess risks to personnel. The agency will announce domestic inspections in advance to ensure a facility is available and safe; however, FDA officials say it will take time to resume the foreign drug inspection program.
The House Committee’s letter closed with the question: How long, after a return to standard operations for domestic and foreign inspections, will it take to clear the backlog? As in other aspects of businesses and daily life, the desire to make up for lost time is urgent.
1. FDA, Resiliency Roadmap for FDA Inspectional Oversight, Report (May 2021).
2. Committee on Energy and Commerce, Letter to Dr. Janet Woodcock (July 22, 2021).
3. J. Wechsler, “FDA Under Pressure to Restore ‘Normal’ Drug Inspections,” www.PharmTech.com, July 28, 2021.
Rita Peters is editorial director for Pharmaceutical Technology.
Vol. 45, No. 8
When referring to this article, please cite it as R. Peters, “FDA Inspections Back on Track?” Pharmaceutical Technology, 45 (8) 2021.