By Riëtte van Laack –
On March 18, 2013, the Government Accountability Office ("GAO") released a report addressing FDA’s use of Adverse Event Reports ("AERs") in overseeing dietary supplements. Specifically, GAO examined (1) the number and source and the types of dietary supplements identified in adverse event reports (AERs) to FDA; (2) actions FDA has taken to help ensure that firms are complying with the AER requirements of the 2006 Dietary Supplement and Nonprescription Drug Consumer Protection Act; (3) the extent to which FDA is using AERs to initiate and support its consumer protection actions; and (4) the extent to which FDA has implemented GAO’s 2009 recommendations for enhancing FDA oversight of dietary supplements.
Since 2008, the supplement industry has submitted mandatory AERs pursuant to the 2006 Act. From 2008 through 2011, FDA received more than 6,307 AERs related to dietary supplements. The majority (71%) of these AERs were submitted by the dietary supplement industry. The number of voluntary AERs stayed constant at about 461 per year. However, the number of mandatory reports, i.e., serious AERs submitted by the industry, increased over time. This increase likely is the result of increased compliance with the 2006 Act.
In addition to AERs submitted to FDA, GAO reviewed data collected by poison centers. GAO’s analysis suggests that, from 2008 to 2010, poison centers received more AERs linked to dietary supplements than did FDA for that same period. Based on these data, GAO suggests that FDA explore possibilities to obtain access to poison center data.
GAO also recommends that FDA facilitate submission of AERS by providing industry with the means to electronically submit AERs and to provide public access to the AERs (currently, AERs for dietary supplements are not publicly available and require a FOIA request).
GAO identified a limited number of enforcement actions, including three warning letters, 15 import refusals and one injunction involving compliance with the 2006 Act. These actions concerned a failure to comply with the requirement to provide a domestic address or phone number to report AERs or a failure by the company to submit AERs it received.
FDA generally agreed with GAO’s recommendations. In its response to the report, FDA indicated that a final guidance clarifying when liquid products may be marketed as dietary supplement or conventional foods is currently undergoing Agency review. In addition, FDA plans to develop a second draft NDI guidance (the first draft guidance yielded more than 7000 comments). FDA did not provide a time frame for completion of this revised draft NDI guidance.
In response to GAO’s suggestion that FDA may be able to expand use of AERs in enforcement, FDA clarifies that most AERs do not result in enforcement because FDA receives a relatively small number of AERs, and it is difficult to determine causality between the product and the health problem based on the limited information in these AERs.
In response to the report, Sen. Durbin (D-Ill.) stated that he plans to reintroduce his Dietary Supplement Labeling Act, which he previously introduced in 2011 (see our previous post here).