A new report out from the Department of Health and Human Services’ inspector general finds long delays between the Food and Drug Administration (FDA) becoming aware of an unsafe product and that product actually being pulled from store shelves.
The IG’s report reviewed 30 FDA recalls between 2012 and 2015, and found that on average, it took 57 days for the recall to start from the time that the FDA became aware of the problem. For example, a 2014 salmonella outbreak linked to nut butter led to 14 illnesses in 11 states. In that case, it was 165 days from when the FDA identified the problem to when the voluntary recall was issued. In a statement, FDA Commissioner Dr. Scott Gottlieb said that while the FDA has addressed some of the issues outlined in the report, there is still work to be done within his agency.
The report follows an alert that was issued on this problem last year, also by the HHS inspector general’s office. In response, the FDA assembled a task force focused specifically on expediting the process high-risk recalls. The agency plans to release guidance in the first half of 2018 regarding what information the FDA can share about where recalled products are sold.
Robert Califf M.D., Food and Drug Administration commissioner from 2016-2017; he is currently a professor and cardiologist at Duke University Medical Center and advisor at Verily Life Sciences, a research arm of Alphabet, Inc. (Google)