Surge in Drug Recalls Expected as COVID-19 Pandemic Wanes in U.S.

The pharmaceutical industry should brace itself for a spike in drug recalls as companies begin returning to normal operations in the U.S. and the FDA looks to catch up on inspection-related activities, a research firm advised in a new report.

The report by Sedgwick, a risk solutions firm, predicts that the FDA will begin scrutinizing drugmakers with a history of product recalls and violations as a large percentage of the U.S. population gets vaccinated and travel restrictions ease up.

Due to the restrictions placed on FDA oversight and enforcement by the COVID-19 crisis, drug recalls dropped by 25 percent in the first quarter of 2021, with just 63 recalls taking place, according to the report. Compared to the fourth quarter last year, there was a 58.5 percent drop in drug recalls in the first quarter of 2021, Sedgwick found. The main catalysts for the recalls were failed specifications, which impacted 4.1 million units in total.

“We are slowly emerging from an era in which FDA oversight and enforcement activities have been restricted, particularly in terms of on-site inspections. As time passes, expect the FDA to focus more on manufacturers with a track record of recalls and violations,” according to the report.

Sedgwick cited an “expanding reach” of contamination-related recalls that are evolving, noting the highly publicized N-nitrosodimethylamine (NDMA) contaminations that, in the past, barely crossed drugmakers’ minds to screen for in their products. The increased scrutiny for NDMA began in 2019, when the FDA identified the nitrosamine impurity in ranitidine-containing drugs, including Sanofi’s blockbuster heartburn med Zantac (ranitidine) (DID, Sept. 13, 2019), and ordered hosts of recalls. Companies should now be defensively monitoring not only for known contaminants but also chemicals and substances that have not been previously identified, the report advised.

“Contamination risks have always been a longstanding risk for pharmaceutical companies. As the industry evolves, expect heightened regulatory scrutiny, litigation and reputational fallout as a result,” Sedgwick said.

The report also notes the growing influence of independent laboratories and safety advocate groups, citing a citizen’s petition by the online pharmacy Valisure to the FDA, requesting a recall of hand sanitizers tainted with benzene. That same company, which previously rang alarms on NDMA contamination in batches of metformin (DID, March 3, 2020), has opened the door for drugmakers and consumers alike to submit samples directly for testing, and other activists have followed suit, the report said.

Read Sedgwick’s full report here: www.fdanews.com/05-20-21-SedgwickUSRecallIndex2021Ed1.pdf. — James Miessler