GAO Issues New Report Warning FDA About Its COVID-19 Inspections Backlog

The Government Accountability Office (GAO) released a new report yesterday warning the FDA about the state of its COVID-19-era inspections backlog, cautioning that the agency needs to develop alternative inspections tools and address its lack of foreign inspections as soon as possible.

The GAO expressed clear concerns about the FDA’s ability to monitor the foreign supply chain. As of May 2020, “74 percent of establishments manufacturing active ingredients and 54 percent of establishments manufacturing finished drugs for the U.S. market were located overseas,” the report states, indicating how reliant Americans are on overseas exports for drug products sold in the U.S.

But the GAO’s worries are not new, with the report saying it “has had long-standing concerns about [the] FDA’s ability to oversee the increasingly global pharmaceutical supply chain … since 2009.” And the GAO noted in December 2019 that “there continued to be vacancies among the investigators who conduct foreign inspections” and that the “FDA’s practice of preannouncing foreign inspections up to 12 weeks in advance could give manufacturers the opportunity to fix problems ahead of the inspection.”

The FDA’s domestic inspections are being adversely affected, too, during the pandemic (DID, March 2). The agency, which has been conducting only “mission-critical” inspections at present, has been pre-announcing “both foreign and domestic inspections for the safety of its staff and manufacturers,” notes the GAO.

The GAO report also reiterates its earlier findings that the FDA did not conduct more than 1,000 planned surveillance inspections for fiscal year 2020 due to the pandemic. In late January, a GAO report on the same topic found that the number of FDA inspections of foreign and domestic firms dropped by 56 percent in fiscal 2020 when compared to the prior two fiscal years.

“Domestic inspections continue to be limited and the vast majority of foreign inspections continue to be postponed as of February 2021,” the new report states, adding that if this trend persists the agency’s inspections backlog could strain resources and hamstring its ability to conduct inspections in fiscal year 2022.

The GAO strongly advises the FDA to develop “alternative inspection tools to maintain some oversight of drug manufacturing quality while inspections are paused. … These include using remote video and other remote and live interactions with establishment staff and records to evaluate drug manufacturing operations.”

And preapproval drug inspections could be affected, despite the FDA’s assertions to the contrary. “As of November 2020, FDA officials told us [the GAO] that the agency had not experienced a significant effect on approval decisions due to the COVID-19 inspection pause,” the GAO says. “[The] FDA notes that it is continuing its work to review and approve drug applications and that, as of October 2020, the agency had approved more than 600 brand-name and generic drug applications in 2020.”

Representatives from unnamed pharmaceutical associations have expressed potential concerns, the GAO report highlights. “Two of these associations noted that the longer inspections are postponed, the more likely the inability to conduct a preapproval inspection could create larger challenges for FDA’s ability to make approval decisions,” says the GAO.

As of last month, the FDA had resumed “some foreign inspections, but had not set a date for resuming routine foreign surveillance inspections in all countries.” Between late October and mid-January, FDA staff in China “had conducted nine preapproval inspections but no surveillance inspections,” and agency officials began conducting inspections in India last month, having conducted two there as of late February.

The GAO does acknowledge some inspections conducted by other regulators can substitute for FDA inspections but “this only applies to certain European regulators whose inspections FDA has found to be equivalent to its own.” Inspections from other nations, including Australia and Japan, can be used for oversight but are not considered acceptable alternatives for FDA-conducted inspections, states the report. However, many drug regulators aren’t conducting live inspections either so it’s unclear how much benefit this could provide though some regulators have turned to virtual and remote-based inspections.

The GAO allows that “in certain cases, [the] FDA can substitute the review of records and other information for conducting a preapproval inspection, but such information alone cannot be used as a substitute for an FDA surveillance inspection.” Advocacy groups, such as Public Citizen, and other industry stakeholders have found remote records reviews to be a poor substitute for actual on-site inspections and believe they limit the agency’s ability to hold a drug manufacturer accountable.

In addition, drug sampling and testing when screening drug imports are not acceptable substitutes for inspections. “Sampling and testing alone do not specifically confirm adherence to quality standards and thus cannot fully replace an FDA inspection,” the GAO advises. According to the report, from March to December 2020, the FDA had put 64 foreign manufacturers on import alert, with most of these based on identified sampling issues.

Click to read the GAO’s latest report on FDA drug inspections: www.fdanews.com/03-04-21-FDADrugInspections.pdf. ― Jason Scott