Energy and Commerce Committee Chairman Frank Pallone, Jr. (D-NJ), Ranking Member Cathy McMorris Rodgers (R-WA), Health Subcommittee Chairwoman Anna G. Eshoo (D-CA), Health Subcommittee Ranking Member Brett Guthrie (R-KY), Oversight and Investigations Subcommittee Chair Diana DeGette (D-CO), and Oversight and Investigations Subcommittee Ranking Member Morgan Griffith (R-VA) sent a letter today to the U.S. Food and Drug Administration (FDA) asking for additional information about the impact COVID-19 has had on inspections of drug manufacturing facilities and what actions FDA has taken, or plans to take, to mitigate experienced and potential future delays of drug approval decisions.
Resuming all inspections and addressing the backlog of delayed inspections at foreign drug manufacturing facilities is important to ensure the safety of drug products, as well as level the playing field for domestic manufacturers.
Key Excerpts of the letter to FDA:
“While we understand that the emergence of COVID-19 required the agency to suspend in-person inspection activities temporarily, we remain concerned that more than one year into the pandemic, the strategy for resuming all inspections and addressing the backlog of delayed inspections remains unclear. The agency’s May 2021 Resiliency Roadmap report states that even under a best-case scenario in which standard operations would have resumed for domestic inspections in May, FDA would only have been able to inspect 50 percent of its remaining fiscal year (FY) 2021 inspections of domestic drug manufacturing facilities. In the meantime, foreign facilities inspected by U.S.-based staff would still only be subject to mission-critical inspections.
“According to a January 2021 Government Accountability Office (GAO) report, FDA inspections of both foreign and domestic manufacturing facilities in 2020 were reduced by 56 percent compared to the numbers of inspections in the previous two fiscal years. Further, FDA reported conducting only three foreign and 52 domestic ’mission-critical’ inspections from March to October 2020, significantly less than the average of 600 foreign and 400 domestic inspections conducted during that time period in previous years. While data recently reported by FDA indicates that there has been an increase in the number of inspections of foreign and domestic establishments conducted since GAO’s findings, FDA’s Resiliency Roadmap indicates that COVID-19 likely will continue to impede in-person inspections, particularly in foreign facilities, throughout 2021.
“Congress previously gave FDA the authority to deploy alternative tools, including utilizing records requests in lieu of certain inspections and recognizing inspections conducted by foreign governments or agencies of foreign governments under sections 704 and 809 of the Federal Food, Drug, and Cosmetic Act (FFDCA), respectively. Further, in an effort to address the continued challenge of postponed in-person facility inspections, FDA released guidance on which activities the agency is willing to conduct remotely. While we are pleased that the agency has demonstrated the usefulness of these alternative tools in supplementing inspection activities, it is largely unclear for which types of inspections, if any, FDA can appropriately use these alternatives as a full substitute for an in-person inspection.
“We are also concerned that we have not yet seen the full impact of delayed inspections, particularly in the case of preapproval inspections (PAIs). PAIs may occur well in advance of targeted dates for drug approval decisions. Therefore, drug applications and approvals may be affected in the future if inspections continue to be postponed, possibly delaying patient access to needed medications. Furthermore, GAO has stated that FDA will face future challenges with its drug approval and surveillance oversight activities if inspection delays continue."
Energy and Commerce leaders asked Acting FDA Commissioner Janet Woodcock a series of questions regarding inspection delays and requested a response by August 5, 2021.
