In a blog posted January 18, 2018, Douglas Stearn, JD, director of the United States Food and Drug Administration (FDA) Office of Enforcement and Import Operations, announced that the FDA will move more quickly to alert the public when a regulated product is recalled.
He explains that recall information is posted on the Enforcement Report at fda.gov. However, it can take weeks to months for the FDA to complete a recall evaluation, which involves determining whether any diseases or injuries have already occurred, the likelihood that a hazard might occur, or whether vulnerable segments of the population, such as children, are more at risk. Therefore, the agency has decided to post “not-yet-classified” recalls of human drugs, foods, and veterinary products in the weekly Enforcement Report, even while the evaluation and risk classification work is still ongoing.
Stearn noted that posting “not-yet-classified” recalls will not affect current FDA protocols for working with companies to ensure that they quickly alert entities in the supply chain to problems with their marketed products, and the FDA will continue to monitor the company’s actions to correct or remove products held by retailers, pharmacies, grocery stores and hospitals.
In addition to adding “not-yet-classified” recalls to the Enforcement Report, the FDA now includes early summaries of correction or removal actions involving serious problems with medical devices in the Medical Device Recalls Database at fda.gov.
“The public should recognize that recalls are almost always voluntary. Sometimes a company discovers a problem and recalls a product, while at other times a company acts after the FDA raises concerns. Whether FDA or the company discovers the problem, in every case FDA oversees a company’s recall strategy and assesses the adequacy of the recall,” Stearn wrote. “If a product is believed to pose an immediate, serious hazard, FDA will also act quickly, even before classification is complete, to widely publicize a recall.”
