In response to a recent report by the Department of Health and Human Services (HHS) Office of Inspector General (OIG), Food and Drug Administration (FDA) Commissioner Scott Gottlieb, M.D., announced that FDA will be issuing guidance on recall communications within the next six months. Commissioner Gottlieb’s announcement followed an OIG report that identified several shortcomings in FDA’s initiation and oversight of food recalls. OIG had issued an “early alert” in June 2016 notifying FDA of its preliminary finding that FDA lacks policies and procedures to ensure that firms or responsible parties initiate food recalls promptly. The complete report issued in December includes additional findings concerning issues such as the timeliness of FDA’s evaluation of health hazards and audit checks, as well as actions FDA has taken in response to the early alert. We summarize the report’s findings and the policy initiatives Commissioner Gottlieb has announced in response to it in the post below.
