Lawmakers Seek Answers on Drug Inspection Delays During the Pandemic
The FDA said earlier this week that domestic inspections are getting back to normal.
A bipartisan group of lawmakers is pressing the Food and Drug Administration for information on how it will address the backlog of drug facility inspections, especially foreign ones, due to the pandemic.
The FDA oversees the safety and effectiveness of drugs marketed in the United States, regardless of where they are produced. In March 2020, the FDA paused most foreign and domestic inspections and then last summer began to resume some domestic ones. In April 2021, it also released guidance for voluntary remote inspections. FDA’s foreign and domestic inspections were decreased by 56% in fiscal 2020 compared to each of the two previous fiscal years and the agency only did three foreign and 52 domestic “mission critical” inspections from March to October 2020, according to a Government Accountability Office report issued in January. Acting FDA Commissioner Dr. Janet Woodcock said at an event earlier this week that, as of this month, the agency has been working to get back to traditional operations for domestic inspections and for foreign inspections is still prioritizing mission critical work.
The top Democrats and Republicans on the House Energy and Commerce Committee and its health, and oversight and investigations subcommittees acknowledged FDA had to temporarily pause in-person inspections due to the pandemic, but said in a letter to Woodcock on Thursday: “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 lawmakers added: “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.”
When asked for an update on the backlog of inspections Friday, the FDA directed Government Executive to its Resiliency Roadmap released in May. There were 23,297 total surveillance inspections remaining through fiscal 2021, 857 of which were for human drugs (515 domestic inspections and 342 foreign), said the report, which also outlines how the agency can tackle them under “base,” “best” or “worst” case scenarios. The report does not note how many inspections were pending at that time during previous years.
The report also notes that 48 of the 68 application decisions delayed from March 2020 to 2021 due to pending inspections or facility assessments were for drugs, but it was unclear how long it would take to address them. The lawmakers did not include any data points more recent than May in their letter.
The lawmakers said they are also concerned that they haven’t seen the “full impact” of the pandemic on preapproval inspections, which ensure that an establishment is capable of producing a drug and the data the company submitted is complete and accurate, according to the Regulatory Affairs Professionals Society. “Therefore, drug applications and approvals may be affected in the future if inspections continue to be postponed, possibly delaying patient access to needed medications,” wrote the lawmakers. They asked for answers to a list of questions by August 5, which include:
- When does the FDA anticipate it will resume normal operations for foreign inspections?
- Has the agency looked at how delayed inspections could impact its ability to make decisions on drug approvals in the months and years to come?
- Is the agency considering if it will expand the foreign countries with which it has “mutual recognition agreements” for inspections abroad?
- Has the FDA thought about how it can improve its remote inspections as part of its multi-year modernization of its data platforms and interoperability infrastructure (how products and systems work together)?
- How is the agency’s Center for Drug Evaluation and Research using the $38.3 million it received from the American Rescue Plan to resume normal domestic operations and prepare for the resumption of standard foreign ones?
- A GAO official said during a House hearing in March that the FDA was preannouncing all inspections in light of the pandemic. What is the FDA’s plan to go back to unannounced ones?
- How long does the FDA think it will take to resolve the backlog of inspections due to the pandemic after a return to standard operations both domestic and foreign?
“The FDA will review the letter and will respond directly to the representatives,” an agency spokesperson told Government Executive in a statement. “Given the uncertainty of the pandemic, the FDA is weighing all possible scenarios and we have been closely monitoring travel advisories to ensure safe travel to other countries. Mission-critical foreign inspections will continue to be the priority for foreign work and FDA will continue to conduct these foreign inspections to protect and promote public health.”