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FDA Releases Report on Inspections

On May 5, the Food and Drug Administration (FDA) released a report entitled “Resiliency Roadmap for FDA Inspectional Oversight” discussing its efforts to conduct inspections of food and medical product establishments during COVID-19 and its plan to ensure a more consistent state of operations moving forward.

In March 2020, FDA postponed routine domestic and foreign surveillance facility inspections and focused only on mission-critical inspections.  Mission-critical inspections occurred when a facility was manufacturing a product that:

  • Had received a breakthrough therapy or regenerative medicine advanced therapy designation;
  • Required follow-up due to a recall or there was evidence of serious adverse events or foodborne illness outbreaks;
  • Were used to treat a serious disease or medical condition and there were no substitutes; or
  • Were related to FDA’s COVID-19 response.

FDA reports that, during this time, it conducted 821 mission-critical establishment inspections (including 29 in foreign countries). On July 10, 2020 FDA announced it intended to begin resuming some domestic inspections by prioritizing facilities using its “COVID-19 Advisory Rating System.”  From March 2020 – March 2021, the agency conducted an additional 777 domestic inspections, 511 of which were for human and animal food and 266 were for human and animal medical products and tobacco.

The report also outlined some of the approaches it took to perform inspections during the pandemic including:

  • Reviewing records and information from facilities in advance of drug or biological product inspections;
  • Using remote assessments to examine facility records;
  • Using information provided by state, local, tribal, and territorial regulators;
  • Reviewing information shared by foreign regulatory partners;
  • Sampling and analytically testing FDA-regulated products domestically and at international borders; and
  • Refusing entry of unsafe imported products.

Since March 2020, FDA completed 440 medical product application-based inspections, that is inspections that are necessary for drug and device establishments prior to FDA approval of a drug application or supplement.  Of the more than 13,500 applications for medical product approval or authorizations received since last March, the agency reports that only 68 applications have been delayed due to the lack of inspections, seven of which were deemed mission-critical.

The agency is now playing “catch up” and has a heavy inspectional burden ahead.  In order to meet its FY 21 performance target, FDA will have to complete 115 out of the 164 planned “official action indicated”/compliance inspections.  The agency will also have to make significant progress in meeting its surveillance inspections target for FY21.  FDA planned to perform 26,250 inspections in FY 21 but has only conducted 2,953, leaving 23,297 inspections outstanding (19,245 for human and animal food and 4,052 for human and animal medical products and tobacco).

In a base-case scenario where standard operations resume in July, 14% of the 15,514 domestic surveillance inspections still to be conducted would occur.  In a best-case scenario where standard operations resume in May, 27% of all domestic surveillance inspections still to be conducted would occur.  Under a worst-case scenario, FDA would continue to perform mission-critical work and would use alternative oversight tools.

FDA’s lagging inspectional activities have caught the attention of Congress.  On March 9, The House Appropriations Committee’s Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Subcommittee held a hearing on FDA’s foreign drug inspections program, featuring testimony from Dr. Mary Denigan-Macauley of the Government Accountability Office.  During the hearing, Chairwoman Rosa DeLauro (D-CT) and Subcommittee Chairman Sanford Bishop (D-GA) both expressed concern over the decrease in the number of overseas inspections performed by FDA and the agency’s reliance on foreign regulators.  Several members of the committee also criticized FDA’s issuance of advance inspection notices to foreign drug manufacturers.

In another effort to address the backlog, on April 14, FDA issued Guidance for Industry entitled “Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency.”  Under the Guidance, remote interactive evaluations will be considered for certain types of drug inspections – specifically, for certain preapproval and prelicense inspections, post-approval inspections, surveillance inspections, and follow-up/compliance inspections.  The agency announced it would used teleconfercing, livestreaming video, and screen-sharing technologies under certain circmustances but was equally clear that these remote interactive evaluations are not meant to replace in-person inspections.  They can, however, be used to support drug approval decisions and certain enforcement actions, and can aid in prioritizing facilities for future inspections.  Under the Guidance, FDA will not allow applicants or facilities to request remote interactive evaluations but will make these decisions itself and will employ a risk management approach to determining when to use a remote interactive evaluation.

FDA will work to consider regulatory approaches to increase efficiency, ensure product quality, and fulfill its public health mission.  The agency will also work with trusted regulatory partners, consider lessons learned across the agency, expand its workforce, and undertake a multi-year modernization effort to improve its data infrastructure.  FDA will continue to focus on mission-critical and prioritized inspections throughout COVID-19 and routine surveillance work will take a lower priority.

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