FDA Creating New AER System 30439

BETHESDA, Md.--The Food and Drug Administration's (FDA) Center for Food Safety and Applied Nutrition (CFSAN) is in the midst of creating a new, more comprehensive system for adverse event reports (AERs). The system, known as the CFSAN Adverse Events Reporting System (CAERS), will track and analyze AERs regarding food (which includes food additives), cosmetics and dietary supplements. CAERS, once fully implemented, will take the place of the Special Nutritional Adverse Event Monitoring System that had been used for AERs associated with dietary supplements. Information gathered via CAERS will assist FDA in formulating and disseminating CFSAN's post-marketing policies and procedures.

CAERS would replace the "patchwork" of existing AER systems that have been maintained by individual offices within CFSAN. Currently, food, cosmetic and dietary supplement AERS are being inputted into the system.

Despite the timing of this announcement, the new AER system is not related to the recent issues surrounding Metabolife or Quorn products, according to FDA. In December 1999, FDA began thinking about updating the AER system. Once funding began coming in, as of fiscal 2001, the project moved beyond the drawing board stage. In all, $5 million has been allocated for CAERS.

CAERS is currently being test piloted and will not be fully operational until May 2003. Right now, the software is being developed for the AER system, and it still needs to be tested. CAERS will also have security features in place that will prevent people outside FDA from hacking into the system. The database will also have search capabilities, and it will allow FDA to create a trends analysis of reports to pinpoint unusual reports or patterns of reports. During the test-pilot phase, CFSAN's internal AER systems will continue to operate.

At a press conference announcing the new system, Ken J. Falci, Ph.D., director of CFSAN's Office of Scientific Analysis and Support, stated the current AER systems were not able to talk to each other and the best and easiest solution was to combine them under one system--CAERS. "The old system we've been using for food, cosmetics and dietary supplements will continue to operate until we can get the new CAERS system functional," he said, adding that the old system will still be used in tandem with CAERS until FDA feels confident about the new one's capabilities.

CAERS also includes FDA sending letters that notify companies about AERs; the letters will contain a redacted copy of the AER to protect consumer identity. In addition, CFSAN encourages manufacturers receiving letters to share with the center "information that is relevant and useful concerning this adverse event or others that you may be aware of involving your product." The notification letters will be sent for AERs received on or after Sept. 16. Previously, FDA had not sent letters to companies.

"It is not our intent to send a letter out every time we get [an AER], and it is also not clear if every piece of information is important enough to follow up on it," he said, adding that it may take a month to follow up with a consumer complaint.

The AER site for dietary supplements has already been taken down, which will be replaced with a CAERS site when ready. The intention for this new site, according to Falci, is to try to put out information that is more consumer-friendly and valuable to the press as well as industry. The Web site will probably will go live in FDA's fiscal 2004, according to Falci.

The reason the old system is coming down, Falci said, is it was not consumer-friendly and FDA had limited resources to maintain the site. "People were not getting clear or accurate information from that site because we haven't had the resources to update the site," he explained.

The National Nutritional Foods Association's (NNFA) legislative director, Kim Smith, stated that the industry has been asking FDA for a long time to come up with a better AER system. "We would like to see the whole system in total be effective and help us track and respond to AERs," she said, adding that NNFA plans to submit comments regarding what FDA has done so far and what it plans to do, including advice on how FDA can help consumers better search the AER database.

For those wishing to comment on FDA's new AER system, send letters to CAERS, 5100 Paint Branch Parkway, College Park, MD 20740.