Congress Seeks More Info from FDA on COVID’s Impact on InspectionsBy
A bipartisan group of members of the US House of Representatives sent a letter to the US 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 the FDA has taken, or plans to take, to mitigate experienced and potential future delays of drug approval decisions.
The letter was signed by the following members of the House of Representatives: (1) Energy and Commerce Committee Chairman Frank Pallone, Jr. (D-NJ); (2) the Energy and Commerce Committee’s Ranking Member, Cathy McMorris Rodgers (R-WA); (3) Chair of the Health Subcommittee of the Energy and Commerce Committee, Anna G. Eshoo (D-CA); (4) Energy and Commerce Committee’s Health Subcommittee Ranking Member, Brett Guthrie (R-KY); (5) Energy and Commerce Committee’s Oversight and Investigations Subcommittee Chair, Diana DeGette (D-CO); and (6) Energy and Commerce Committee’s Oversight and Investigations Subcommittee Ranking Member, Morgan Griffith (R-VA).
The FDA announced in March 2020 that it would temporarily postpone facility inspections other than those deemed mission critical and proceeded with ways to conduct inspectional work remotely, for example by evaluating records in lieu of an in-person inspection where appropriate.
In their letter, the House members stressed the importance of resuming all inspections and addressing the backlog of delayed inspections, particularly at foreign drug-manufacturing facilities “to ensure the safety of drug products as well as level the playing field for domestic manufacturers.” The House members raised concerns regarding continued challenges of postponing in-person facility inspections and alternative tools in supplementing inspection activities.
“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 July 22, 2021 letter said.
The House members pointed to a FDA report that stated that even under a best-case scenario in which standard operations would have resumed for domestic inspections in May (May 2021), the FDA would only have been able to inspect 50% of its remaining fiscal year (FY) 2021 inspections of domestic drug-manufacturing facilities. In the meantime, foreign facilities inspected by US-based staff would still only be subject to mission-critical inspections.
Overall, FDA inspections of both foreign and domestic manufacturing facilities in 2020 were reduced by 56% compared to the numbers of inspections in the previous two fiscal years, according to a January 2021 report by the Government Accountability Office (GAO). The FDA reported conducting only three foreign and 52 domestic “mission-critical” inspections from March to October 2020, 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 indicate 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,” said the letter.
The House members acknowledged the ways in the FDA has sought to address the continued challenge of postponed in-person facility inspections, such as by FDA guidance on which activities the agency is willing to conduct remotely, but urged that more needs to be done.
“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,” said the letter. “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.”
To this, the Energy and Commerce committee members raised concerns that drug applications and approvals may be affected in the future if inspections continue to be postponed.
The Congressional members have asked Acting FDA Commissioner Janet Woodcock a series of questions regarding inspection delays and are requesting a response by August 5, 2021.