FDA Drug Recalls Rise in 2020, New Report Says

Drug recalls in 2020 climbed to 344, a 2.4 percent increase from the previous year, although that small increase was overshadowed by the amount of drugs actually impacted by the recalls, a new report says.

The number of recalls in 2020 affected almost 133 million units of drug products, a stunning 50.6 percent increase of units compared to 2019, according to the 2021 State of the National Recall Index put out by insurance claims company Sedgwick.

Current good manufacturing practices (cGMPs) were the leading cause of recalls in 2020, accounting for 47 percent of all recalled units (63 million units). By comparison, cGMPs were also the chief cause of recalls in 2019 and the second-leading cause in 2018, behind failed drug specifications, the report notes.

On that front, Sedgwick predicts the carcinogen N-Nitrosodimethylamine (NDMA) will result in  recalls and litigation in 2021, following its discovery in 2019 in certain heartburn and disease medications. The report details that the FDA recalled 36 products for NDMA contamination in 2020, a three-fold increase over 2019, and regulators and drugmakers will continue to try to understand exactly how this contamination occurs.

The FDA is also expected to maintain its vigilance in monitoring COVID-19-related products meant to reduce transmission, and therapeutics and vaccines. The report highlights that, as of mid-November 2020, more than 1,200 products had been identified as fraudulent, making them potential targets for recalls or warning letters from the FDA. “As long as COVID-19 remains a concern, these products will stay in the spotlight,” says the report.

In addition, the agency is expected to resume monitoring “hot-button issues,” such as active pharmaceutical ingredient (API) safety, opioids and vaping products, which “have taken a back seat to [the] pandemic response.” The FDA will especially be monitoring APIs, the report suggests: “It is critical for manufacturers, especially during a global pandemic, to be even more diligent with ensuring suppliers are meeting standards and quality requirements.”

The report notes that in September the FDA disclosed it had issued 17 warning letters to pharmaceutical companies regarding the illegal importation and sale of misbranded or unapproved opioids. “These letters are a reminder that the FDA will pursue companies throughout the supply chain, making it even more important the companies understand their risks up and downstream,” says Sedgwick.

Click to read the report: www.fdanews.com/02-23-21-Sedgwick.pdf. ― Jason Scott