Effectiveness of the FDA’s Notification Process

There are questions being raised about the effectiveness of the Food and Drug Administration’s (FDA’s) notification process. In a new study examining the United States Food and Drug Administration’s recall process, researchers found that the FDA did not send notifications for one in five of the most serious recalls through its two electronic systems used to alert doctors and the public. The study focused on recalls between 2004 and 2011, and counted more than 1,700 drug recalls listed in the FDA’s enforcement reports. Ninety-one of those were noted to be serious Class 1 recalls.

The research revealed that in that time period there were 2,900 announcements through the FDA Recall Alert System. This system is designed to send notifications to subscribers about recalled drugs and products. But of the 91 Class 1 recalls, alerts were only sent for 55. Another system, MedWatch, also reported drug recall information and is used by the FDA. They sent 18 recalls for the remaining (unreported) recalls. But that left 18 recalls (one-fifth) completely unreported.

The authors of the study noted, “Despite recent efforts by the FDA to address the drug recall burden, health care providers may be inadequately informed about clinically important recalls that threaten patient safety.” The FDA seems to comprehend there is a problem, and only time will tell if they are able to rectify the gap in notifying health care providers of this critical information.

If you or someone you know has been harmed by a recalled product, contact the attorneys at Abraham, Watkins, Nichols, Agosto, Aziz & Stogner by calling (713) 222-7211 or 713-222-7211.