The Food and Drug Administration has resumed domestic biopharma inspections for the first time since March 2020. But not surprisingly, the agency finds itself confronting a major pandemic backlog.
At a regulatory event this week, acting FDA commissioner Dr. Janet Woodcock announced that, as of July, the agency had “begun transitioning back to standard operations for domestic inspections, while continuing to prioritize mission-critical work for foreign inspections.”
A halt in on-site visits during the COVID-19 pandemic led to an accumulation of more than 8,000 delayed non-mission-critical surveillance inspections – including food and drug products – as well as around 50 delayed human drug applications.
While experts agree the announcement represented a step in the right direction, a return to some semblance of normalcy won’t come without its challenges.
Dr. Michael Carome, director of the Health Research Group at advocacy organization Public Citizen, noted the importance of recognizing the two types of inspections carried out by the FDA carries out: Ones that occur prior to approval for a new drug and ones that take place post-approval, which aim to ensure that companies maintain acceptable levels of quality, safety and efficacy. Both types of on-site inspections were halted at the start of the pandemic shutdown.
It’s unlikely the FDA will catch up anytime soon. “Because there remains such a substantial backlog, it’s likely that it’s going to take a very long time for the FDA to clear that backlog and get back to where they should be – both in terms of doing pre-market inspections and the post-market surveillance inspections,” Carome explained.
While a large number of the backlogged inspections are related to food products, as of May more than 850 remaining inspections were for human drugs. Of that sum, 515 were for domestic sites and 342 were for overseas sites, according to an FDA report released that month.
Back in March, the U.S. Government Accountability Office released a report flagging the issue of inspection delays. It noted that between March 13, 2020 and the end of the year, the FDA completed only three foreign inspections considered mission-critical. In prior years, the FDA had conducted more than 600 overseas inspections in similar time frames.
GAO director of health care, public health and private markets Mary Denigan-Macauley said the FDA acknowledged concerns flagged in the report and agreed with some of GAO’s recommendations. It’s still unclear, however, exactly how the FDA plans to tackle the 8,000-plus needed inspections.
“We’re not 100% sure that we understand [Woodcock’s] comments. Because when she testified, it sounded like [the FDA] would be going back to normal operations,” Denigan-Macauley explained.
“She said the FDA has activated [its] base-case scenario, which means they will focus on mission-critical and prioritize domestic inspections and resume standard operations in July. But then later in the testimony, she said their primary focus will just be mission-critical, which means the normal surveillance to determine the safety and efficacy of those drugs that are already on the market would not be prioritized. It’s not 100% clear from her testimony.”
Denigan-Macauley added that while it’s a good sign the FDA will resume its focus on domestic inspections, the agency still hasn’t shared specific plans for doing so. As for the on-site foreign inspections, well, it’s anybody’s guess.
“If they are going back to full domestic activities, it will help, but it won’t have as big an impact as they say it will,” Denigan-Macauley explained. “Sixty percent of the facilities that are manufacturing drugs are overseas. Out of 4,200 facilities, 60% are in China and India, where the pandemic is of course [still] a major concern.”
As a result, Denigan-Macauley added, “There’s no question that the backlog will continue.”
So even if operations return to normal domestically, full-on “normal” will remain elusive. For one thing, the absence or shortfall of physical, in-person inspections in foreign facilities could jeopardize the quality and safety of drugs for consumers. It could also result in altered manufacturing records, hygiene and cleanliness issues.
Denigan-Macauley believes that chipping away at the domestic backlog will at least help free up resources. But Carome countered by noting that the FDA might need to readjust its approach, perhaps by ramping up its head count.
“One way the agency might try to deal with this is by minimizing the duration and cutting short the rigor of the inspections in order to try to get them completed more quickly,” he said. “That would not be ideal, because it would reduce the quality of inspections. What’s probably needed here is for the FDA to ramp up the number of inspectors that they have.”