FDA to Improve Product Recall Process for Drugs, Medical Devices and Food

FDA Commissioner Scott Gottlieb has issued new draft guidance aimed at notifying the public about product recalls in a better, faster way. The regulator originally announced they’d be changing this process last month.

“Recalls are an important safety tool,” said Gottlieb. “The FDA works with companies to get potentially unsafe products out of the marketplace as quickly and efficiently as possible. When we learn about a product in the marketplace that may be unsafe, the FDA must act quickly to keep people from getting sick or being harmed.”

The draft guidance covers a number of recall-related procedures, including when a public warning should be issued, what information should be included, and when the FDA will step in to issue its own recall alert. Perhaps most important for manufacturers is the FDA’s draft guidance on posting recall information on the regulator’s weekly Enforcement Report.

In the past, the FDA has waited to post recall information on the publicly-available Enforcement Report until a classification as to the severity of the recall has been made. However, as this process can sometimes take months, leaving consumers open to potential risks associated with using or consuming the affected product, the FDA has proposed posting the recall before the health risk determination has been finalized.

“Making sure the FDA has effective recall practices in place, and that we take immediate action to address unsafe products, are high priorities of mine,” said Gottlieb. “Our recall authorities – and how we deploy them – are a cornerstone of our vital, consumer protection mission and I take these obligations very seriously.”

The draft guidance also has the potential to impact retailers that may have sold food products later affected by a recall. When it comes to a food recall, the FDA usually publishes lot codes, along with full descriptions and images of the product, however they may begin to identify stores that sold the recalled food, if that information is available.

In a related blog post, Douglas Stearn, J.D., FDA’s Director, Office of Enforcement and Import Operations, Office of Regulatory Affairs, emphasizes that most recalls are issued on a voluntary basis by the company responsible for producing the affected product. Still, the FDA oversees the recall process and reserves the right to take over if a company’s efforts are deemed to be insufficient.

“We all know that hazardous recalled products can have a devastating impact on human lives,” said Gottlieb. “We’re committed to making sure that recalls are initiated, overseen, and completed promptly and effectively to best protect consumers; and we will use all the tools at our disposal to carry through on this commitment.”