FDA Wants More Transparency on Drug Recall Data and Causes

FDA is looking to create more transparency around the data it collects on product recalls and their underlying causes.

The agency’s effort to capture the right recall data, including root cause, and to standardize how it is interpreted was the focus of a presentation by CDER’s Office of Compliance Division of Manufacturing and Product Quality (DMPQ) Deputy Director Michael Smedley at the Consumer Healthcare Products Association (CHPA) Manufacturing Controls Seminar in mid-October in New Brunswick, New Jersey.

FDA has noted confusion in the last few years, including in the press, over “what is a recall and what is an event.”  Smedley emphasized that looking at recalls in terms of the number of products involved in an action can be misleading and proposed that looking at them by “event” instead is more indicative of the state of industry compliance.

[More on the issues around interpreting FDA recall data and the agency’s efforts to improve the usefulness of its data is provided for subscribers here.  To subscribe to IPQ, click here.]