During 2021, lawmakers, government officials and top FDA officials racked their brains to find a solution to the agency’s heavy drug manufacturing inspection backlog. The regulator has started righting the ship at home, but overseas problems persist.
And while much of the attention to the FDA’s backlog has focused on delays in approving new drugs, this also poses problems for those who have received reports from the regulator, who rely on these inspections to clear warning letters or import alerts.
In its mid-November update of its “roadmap” for inspection resilience, the FDA reported 52 new drug request delays due to the agency’s backlog of pandemic-related inspections, up from 48 delayed requests reported in May. At the same time, however, the regulator exceeded its expectations for the number of US inspections it could eliminate.
So what does next year have in store for us? In terms of domestically produced inspections, there is a possibility that the FDA may complete its backlog.
Given the progress the FDA has made in its country, “it seems reasonable to us to assume that, because the FDA was able to resume its national surveillance inspections in July of this year, it was able to make progress on the national backlog. since our last report, ”said Mary Denigan-Macauley, director of health care at the Government Accountability Office (GAO).
Despite the agency’s home inspection improvements, it’s a much different story abroad, added Denigan-Macauley. Given the issues the FDA faces on this front, many of which predate COVID-19, the chances of the FDA reducing its backlog of foreign inspections appear slimmer, and “certainly not by next year.” , she said. Judy McMeekin, Associate Commissioner of Regulatory Affairs at the FDA, said in an email interview that “throughout the pandemic, we have continued to conduct critical overseas inspections and have successfully conducted inspections in nearly 30 countries ”. She also noted that the regulator is developing a strategy to increase overseas surveillance inspections next year.
Course correction in the United States
In the United States, the FDA resumed operations as usual in July. In November, it said it had completed 1,139 out of 3,229 pending inspections for medical products and devices.
“We have exceeded our target of completing national surveillance oversight activities as outlined in the resilience roadmap for the FDA inspections oversight report released in May,” said McMeekin.
This includes follow-ups from previous inspections which resulted in an official tag indicating action, McMeekin added. Thanks to the agency’s risk-based approach, the FDA is now conducting home inspections that COVID-19 previously failed, she said.
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The agency does not yet have data on the number of additional national inspections completed since its November update, but it plans to share the information at a later date, McMeekin said.
GAO in January warned that the FDA needed to clear its backlog, lest the regulator hamper its goal of shifting to exclusively risk-based surveillance inspections. The office urged the FDA to take the backlog into account when developing forward-looking inspection strategies, as well as finding alternative inspection tools and determining whether new options will provide the information needed to complete the inspections. regular activities or responsibilities of the agency when inspections are not possible in the future.
Meanwhile, the problems the FDA faces overseas may be difficult to overcome in 2022 alone. In its latest update to the resilience roadmap, the agency telegraphed its intention to forge a plan to resume overseas inspections from next February. Omicron could disrupt those plans, but there is no doubt that the FDA’s roadmap for resilience is a “step in the right direction,” Denigan-Macauley pointed out.
The overseas surveillance inspection program will rely on inspection staff based in the United States and overseas in places where travel restrictions have been lifted, McMeekin explained.
From March to October last year, the FDA performed just three critical overseas inspections, GAO reported earlier this year. This compares to about 600 foreign inspections the agency conducts each year under normal circumstances.
The situation improved in 2021, but the inspection activity was still low. Between April and September 2021, the regulator performed just 37 foreign drug inspections, three foreign veterinary drug inspections, four foreign medical device inspections, and two foreign biologics inspections.
Like many organizations during the pandemic, the FDA used a mix of digital and remote tools. But while remote inspection tools are a vital resource during the pandemic, in-person inspections are “the key” to what the agency does, Denigan-Macauley added. Ultimately, the FDA must use these alternative oversight tools, such as remote inspections, requesting registrations, and the use of certain other overseas regulators, to supplement rather than replace its traditional inspections.
On the front of foreign inspections, the FDA has been struggling since before the pandemic. Vacancies and language barriers are two big issues, Denigan-Macauley said.
The good news is that the FDA “is actively working on these issues,” McMeekin said. For example, she highlighted a pilot program that the regulator plans to launch in 2022 which aims to “improve the translation capacities of drug inspections abroad”.
She added that investigator staffing levels are essential to the agency’s mission and that the regulator is actively recruiting. He is specifically looking for “foreign executives” who are based in the United States but travel to foreign countries to perform inspections, McMeekin said.
Going forward, the FDA says it will continue to prioritize “mission-critical” work as well as other “higher-level” inspection needs such as cause inspections.
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In July, the agency deployed the FDA Inspection Affairs Board to develop a multi-year action plan around inspections, information sharing and other processes to “expedite assessment and integration. potential of new monitoring methods and tools ”. One of the responsibilities of FIAC is to propose an agency-wide policy and procedure for remote regulatory assessments.
“We have learned through our own experiences so far and by discussing remote assessment approaches with our overseas counterparts, that remote assessments have presented significant technical challenges and require more resources than expected,” said McMeekin from the FDA. Some of these factors include the logistical challenges of time zone differences as well as the inevitable IT issues associated with live streaming content.
The FDA has relied on these alternative assessments to strengthen its surveillance during COVID-19, but remote reviews do not meet in-person requirements for surveillance inspections. By going digital, the FDA could reduce the number of user fee delays it clears, but it will still be struggling with hundreds of surveillance inspections that require in-person contact.
“Ideally, inspections complemented by additional tools, including registration requests and remote interactive assessments, will provide us with the greatest depth of information,” said McMeekin. “Information obtained through remote assessments can be used to support regulatory decisions, including application approvals and to take regulatory action, including warning letters,” she added. These remote assessments can also “supplement” information received by other mechanisms.
Ultimately, the FDA will have to rely on a healthy mix of old and new, which GAO’s Denigan Macauley and FDA’s McMeekin pointed out.