U.S. FDA Commissioner Scott Gottlieb, MD, announced that the agency has developed new policy steps for strengthening product recalls. Specifically, Gottlieb revealed, the FDA has published a draft guidance that better explains the FDA’s policy on public warnings and device recall notifications—in an effort to provide more timely information to consumers.
“The draft guidance outlines circumstances when a company should issue a public warning about a recall, describes the general timeline for companies to issue such a warning, discusses what information should be included in a public warning, and describes situations where the FDA may take action to issue its own public warning should a company’s warning be deemed insufficient,” Gottlieb said.
“The draft guidance also describes the FDA’s policy for moving forward with posting recalls to FDA’s Enforcement Report before a final health risk determination is made.” (For reference, the FDA’s Enforcement Report lists all the recalls the FDA is monitoring.)
To Gottlieb, it’s a cause that is close to his heart. After all, he said, ensuring that the FDA has “effective recall practices in place” and takes immediate action to handle hazardous products are key priorities of his. “Our recall authorities—and how we deploy them—are a cornerstone of our vital, consumer protection mission and I take these obligations very seriously,” he added.