In Q2 2022, the number of recalled units in the U.S. pharma industry dropped sharply. In the first quarter of the year, drug makers recalled more than 435 million units. However, the number of recalled units in Q2 2022 was 20.5 million, according to the Sedgwick Brand Protection Q2 2022 recall index.
“It was definitely a big drop,” said Chris Harvey, senior vice president at Sedgwick. But the steep reduction doesn’t mean the FDA is taking its eye off the ball.
This year could end up a record-setting year for pharma recalls. The number of recalls between Q1 and Q2 was flat at 94 quarter over quarter. That figure is “up from some of the previous quarters that we’ve seen to the pandemic,” Harvey said.
The Q1 2022 numbers had a handful of extensive recalls involving OTC products skewed the numbers. Lot sizes for OTC products generally have substantially wider distribution and lot sizes than prescription drugs. For example, one OTC recall in the first quarter involved more than 300 million units. “And a couple of others were quite large with over 60 million units recalled. Another was over 26 million,” Harvey said.
By contrast, Q2 didn’t have similar recalls involving tens or hundreds of millions of recalled units. “The largest one in Q2 was about 7.2 million,” Harvey said.
While heightened regulatory scrutiny is likely in the pharma sector in the near future, the pandemic has made it difficult to gauge the regulatory environment. The FDA and other regulatory agencies continue to address challenges resulting from the pandemic — most notably related to a reduction in on-site inspections and audits. There has been a corresponding increase in remote regulatory assessments and electronic audits. “We’re seeing improvements from the agency in how those [remote assessments and audits] are executed,” Harvey said. “They are becoming more streamlined.”
FDA is likely to continue refining how it uses tools such as teleconferencing and sharing of information electronically in the coming months.
In recent years, the agency has also stepped up its scrutiny of toxic nitrosamine impurities in drug substances and drug products.
As the FDA adapts to the post-pandemic landscape, the pharma industry must contend with labor shortages, supply chain issues and raw material shortages. “It’s more important than ever for pharma and device manufacturers to have good procedures in place to understand their supplier verifications and identify where they have vulnerabilities,” Harvey said. “That’s an area where you could see a continued increase in warning letters.”
Sedgwick recommends that pharma companies keep a close eye on the FDA’s recent warning letters and recalls to understand what the agency is prioritizing and how it is managing its current infrastructure. “It’s important for manufacturers to look at which similar products are having issues and where the FDA is focused,” Harvey said.
In terms of recalls, many of them are avoidable with sufficient planning. The reasons for recalls include cGMP deviations, failed specifications and mislabeling. Other causes include incorrect lot numbers, expiration dates and testing instruments that are out of specification.
Again, the ongoing pandemic and supply chain constraints continue to pose problems. “The current labor shortages and high product demand are contributing to the fact that you’re probably not training employees as much as you have in the past,” Harvey said. “There needs to be a heightened corporate culture for quality now that is instilled into current, new and temporary employees.”