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FDA acting commissioner Janet Woodcock has outlined FDA’s plan to “transition to standard operations” for U.S. inspections.
Congressional leaders, as well as regulated industry, want more information from FDA on its strategy for resuming inspections of manufacturing facilities to better assure the quality, safety and efficacy of medical products. The suspension of in-person field inspections in March 2020 has resulted in a huge backlog of delayed site visits, as FDA sent investigators only to those operations deemed “mission critical.”
FDA acting commissioner Janet Woodcock recently confirmed that the agency is returning to normal procedures for domestic inspections, although foreign inspections still will be limited to mission-critical situations. In testimony before the Senate Health, Education, Labor and Pensions (HELP) Committee on July 20, 2021, Woodcock outlined FDA’s plan to “transition to standard operations” for U.S. inspections, which still means focusing on higher-risk establishments and scheduling postponed surveillance inspections based on risk.1
Meanwhile, Congressional leaders continue to demand more information on how and when FDA will resume standard operating procedures for inspections, reflecting concerns that postponed oversight may delay the approval of new drugs and biologics. In a lengthy letter to Woodcock dated July 22, 2021, Republicans and Democrats on the House Energy and Commerce Committee requested details on the status of foreign inspections; whether delayed inspections are hindering the approval of applications for new drugs, generics and biosimilars; FDA’s ability to utilize inspection reports from trusted inspectorates; and how FDA’s data modernization initiative will improve its inspection program. The legislators also want to know how much of the $38.3 million provided FDA to help address the pandemic is being used to support the resumption of domestic and foreign inspections, and the impact of FDA’s decision to pre-announce all inspections for the foreseeable future.2
FDA normally conducts nearly 1,000 foreign and domestic inspections a year for medical products, but has made less than 100 critical site visits in the U.S. in the last two years, and only a handful overseas. In its “Resiliency Roadmap for FDA Inspectional Oversight” issued May 5, 2021, FDA acknowledged that it had postponed most inspections in 2020 due to the pandemic, focusing primarily on manufacturing operations producing drugs needed to prevent critical shortages and to support the approval of novel drugs or treatments for COVID-19.3 For 2021 the agency has some 15,000 domestic surveillance inspections on its to-do list, most of those involving food and other products, but a third related to drugs.
To better manage this considerable volume of inspection work, FDA is aims to enhance the Office of Regional Affairs (ORA) field inspection program through the agency’s data modernization initiative to provide cross-program interoperability, Woodcock reported to the Senate panel. This includes new technology supporting regulatory assessments to improve the receipt, review and analysis of industry data and records, including a review of inspectional approaches using next-generation assessment technologies.
Furthermore, FDA has established a new agency-wide Inspectional Affairs Council to better coordinate inspection approaches and assessments across product centers. This panel aims to “optimize the inspection process,” explained Judith McMeekin, associate commissioner for regulatory affairs, in a presentation July 14, 2021 to the Alliance for a Stronger FDA. McMeekin, who manages ORA’s 5000 inspectors and other staffers, noted that the Council will provide a forum for the leadership of FDA centers to jointly assess strategies and policy issues across operations to ensure optimal use of resources.
McMeekin reported that ORA has conducted about 30 mission critical foreign inspections during the pandemic, which has involved a tremendous effort to mitigate risks to investigators. ORA also worked to facilitate the emergency approval of vital vaccines to combat the pandemic by devising methods to inspect key vaccine clinical research sites, collaborating with the Center for Biologics Evaluation and Research (CBER) to plan the visits. In just four weeks, a team of more than 50 ORA investigators inspected 26 clinical research facilities to ensure the accuracy and reliability of data to be considered by FDA’s vaccine advisory committee. Here, FDA sent in two inspectors, instead of one, to assess data in the shortest amount of time, supplying them with portable projectors able to review documents from a distance.
McMeekin also highlighted ORA’s need for additional funding, particularly to enhance its operations related to drugs and medical products. Only 10% of its budget is supported by user fees, she explained, and most of its appropriated funds are allotted to food safety and oversight. To expand its drug inspection activities, lab capacity and scrutiny of more imported packages containing drugs, ORA is looking to tap more medical product user fee funds, while also increasing appropriated support to bolster its staff dealing with medical devices and biologics, as well as its cadre of foreign inspectors.
In going forward with scheduling of site visits in the U.S., FDA is utilizing a rating system to assess the number of COVID-19 cases in the local area and risks to personnel, in consultation with state and local authorities. And for now, the agency also is pre-announcing domestic inspections to ensure a facility is available and safe for FDA staffers to visit. But FDA officials recognize that it will take some time to restart its foreign drug inspection program due to the more extensive planning required to arrange for safe travel and site visits.