The coronavirus pandemic was a deeply disruptive, global event that sent ripples through just about every industry and occupation. While the Life Science industry has played a central role in combating the crisis, it has not necessarily avoided its own challenges to day-to-day operations.
When the pandemic gained a deep foothold in the U.S. in March 2020, the FDA limited inspections to just “mission-critical” facilities and postponed lower-priority inspections. That created an immense backlog of delayed 2020 inspections, which has slowed drug approvals and fueled shortages. But the FDA has shifted gears and is aiming to trim that backlog at an accelerated rate.
A Return to Normal Operations
We’ve come a long way since the earliest days of the pandemic. There are multiple vaccines available for adults and older children. Treatment regimens for hospitalized patients have improved, and pill-based treatments could be forthcoming from major drug manufacturers. As society has adapted to the virus, case counts have decelerated and business is starting to return to a semblance of normalcy.
Because pandemic-related conditions have improved and the FDA has returned inspections toward “a more consistent state of operations,” the FDA announced the pivot to a “base-case scenario” in July after issuing its “Resiliency Roadmap for FDA Inspectional Oversight.” Since then, the FDA has been ramping up its inspections, aiming to trim its massive backlog of some 15,000 inspections that were delayed in 2020, while also keeping up with current demand. And, to be fair, the FDA has made some headway.
As of Sept. 30, 2021, the FDA had exceeded its base-case scenario projections for the full-year 2021, completing more than twice as many domestic surveillance oversight activities as anticipated. Food inspections were 292 percent ahead of budget, while medical product inspections exceeded the FDA’s forecast tally by 134 percent, according to a November 2021 update. In total, the FDA has conducted more than 1,101 inspections of human and animal products in 2021.
The FDA will continue to prioritize mission-critical and higher-tiered inspections as it continues to work through the backlog. It’s also upgrading its data enterprise systems over the next few years, which should steadily improve efficiencies going forward. Remote inspections have also been deployed, and the agency performed roughly 800 remote inspections from April to September.
Still, even with the pace of inspections progressing ahead of schedule, the FDA has its work cut out for itself. The current level of activity falls short of its “best-case scenario”, which forecast 1,613 inspections. A shortfall in foreign inspections was more acute, given overseas travel restrictions remained in place for much of the year.
The delays have left some uncertainty hanging over the industry, as many Life Science manufacturers are wondering if scheduled inspections will occur this year or if more delays are forthcoming. Indeed, the inspection backlog is expected to persist well into 2022, and new drug and medical device approvals have piled up in the meantime.
Unique Impacts on the Life Science Industry
The stakes are also high for the Life Science industry, particularly in the wake of recent high-profile 483s & recalls. In early 2021, the FDA sent out 80 warning letters and 43 import alerts for issues related to drug manufacturing. The majority of these warnings had to do with testing samples, a major leap from 2020, where 97.5% of warning letters came from onsite inspections and only 2.5% were from testing. There has been an analogous shift in import alerts this year as well, as nearly half of the issues flagged occurred within sample testing, another big jump from the 1.8% in 2019.
The FDA has also sent multiple warnings to Proquimes SA Productos Quimicos Especializados SA, an active pharmaceutical ingredient (API) manufacturer in South America, on account of a handful of manufacturing violations. These warnings are based completely on the firm’s records, as the coronavirus has made onsite inspections difficult to perform. The firm was notified that “without process validation documentation, you cannot determine that your manufacturing process can consistently produce API that meets predetermined quality attributes.”
The above-mentioned examples represent one small section of the FDA-related problems that are hamstringing the Life Science industry. Now that the FDA is aiming to increase its audits and inspections over the next few months, businesses in the life sciences industries will have to put their best foot forward to meet FDA guidelines in an attempt to protect themselves and the people who purchase their products. To meet this heightened demand, businesses may consider enlisting the aid of FDA Quality & Regulatory consulting firms.
Quality & Regulatory Compliance Remains Critical
These are certainly unique times for the pharmaceutical manufacturing industry, and it could be advantageous to work with regulatory experts to navigate an unprecedented environment. Premier FDA Solutions is focused solely on quality and regulatory compliance for the life sciences industry. We will leverage our deep bench of expertise to keep your operations compliant. Whether you need one consultant for a day or several for a long-term project, we can provide the right scale at the right time. Premier FDA Solutions focuses on quality system remediation, FDA audit support, and FDA expert witness services.
As inspections continue to ramp over the next year, Premier FDA Solutions can help your life sciences operation excel. Contact us today to get started!
