We just released our First Quarter 2020 Recall Index with everything you need to know right now about recalls in the food, consumer product, medical device, pharmaceutical, and automotive industries. But since COVID-19’s impact was only beginning to be felt in March, we thought it would be helpful to preview the Second Quarter based on April data.
In April, we saw a drop in medical device and drug recalls, similar to what occurred during last year’s government shutdown. But the same trend didn’t apply to FDA food recalls and CPSC product recalls, which were significantly higher than they were during the 2019 shutdown. The first quarter, together with April’s numbers reveal that recalls continue to occur at a steady rate, even during the pandemic. And as we predicted in our First Quarter Index, it’s almost certainly going to get worse from here.
Consumer concerns continue to grow, placing pressure on Democratic leaders in Congress to pressure regulators to take action on food safety even as the FDA has scaled back regular inspections. In the consumer product industry, the CPSC has initiated recalls linked to product-packaging safety now that children remain home all day. According to our Index, childproof packaging recalls hit a record high in the first quarter, and in April, we saw this as a cause for seven recalls.
Meanwhile, the FDA has implemented emergency authorizations and regulatory discretion to expedite the production of drugs and medical devices in response to COVID-19. We’re seeing companies rushing to create effective treatments and ramping up production to cover product shortages. We’re even witnessing new players, such as automakers, apparel-makers and distillers switching some of their production lines over to making medical devices, protective masks and hand sanitizers.
But when the world opens back up, these emergency authorizations will come to an end and the FDA will return its focus on ensuring drug manufacturers and medical device companies are following the standard approval process.
Sonali Gunawardhana, Of Counsel at Shook Hardy & Bacon, predicts in the First Quarter Index that the FDA will especially target adulterated products and companies making fraudulent claims, which we’re already seeing happen. Criminal complaints from the U.S. Justice Department and civil lawsuits from consumers won’t be far behind. Just because your product passed muster during the COVID-19 era, “it doesn’t mean your company is immune from litigation,” Sonali warns.
So, what do you get when all of these events occur in the immediate aftermath of COVID-19? An inevitable surge in recalls. The experts say there’s no doubt we’ll see a spike, and they will be trickier than ever to manage. So companies would be wise to prepare now for what a recall will look like not just post-COVID-19, but also during a pandemic. Because even if regulatory activity and business operations are able to return to “normal” in the near future, a resurgence in future COVID-19 cases could put us back into lockdown.
Bottom line: Take time now to update your recall and crisis plans while you re-evaluate your supply chains, safety procedures and product-tracking capabilities. There’s never been a more critical time to do so.