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FDA to launch ADR reporting system for dietary supplements

The Food & Drug Administration Center for Food Safety and Applied Nutrition (CFSAN) is developing a new system for tracking and analyzing adverse drug reaction (ADR) reports involving dietary supplements, foods, and cosmetics.

Acknowledging that the FDA gets about 7,000 ADR reports a year about dietary supplements, foods, and cosmetics, an FDA spokesman told Drug Topics, "The new CFSAN Adverse Event Reporting System [CAERS] will help us track information and enable us to do some trend analysis so that we'll have more accurate data. This will help us in making policy decisions and tracking to see whether there are any ADRs associated with certain ingredients. This will speed the review of ADR reports because we'll be on a single electronic system."

CAERS will be pilot-tested this year and is expected to be fully operational in May 2003. The system will eventually replace a patchwork of existing adverse event reporting systems that were maintained by individual offices within CFSAN for cosmetics, dietary supplements, and foods.

CFSAN will write letters notifying companies when the center receives a report of an illness or injury allegedly associated with the use of one of their products. The agency will also encourage companies to share information when they become aware of adverse events relating to their products. "By sharing these data with the firms, we hope to be more responsive to consumer protection efforts and to better prevent any further injury from an adverse event," said the spokesman.

Mark Blumenthal, American Botanical Council's CEO, told Drug Topics, "It's a welcome development that the FDA is improving the way it reports adverse events associated with dietary supplements. The FDA has been criticized for its MedWatch system for its many inaccuracies and lack of good documentation. Hopefully, CAERS will improve the quality of documentation, which in many cases is sorely lacking as to what the actual product was. Making this consumer-friendly is OK, more important is that members of the health profession, media, and industry be able to rely on the reports the FDA provides and makes available."

Rick Kingston, Pharm.D., associate professor, department of experimental and clinical pharmacology, College of Pharmacy, University of Minnesota, and senior clinical toxicologist Prosar International Poison Center, St. Paul, was less enthusiastic in his assessment of the new FDA system. "It's a step in the right direction, but any system that just automates the ability to search a database of unsubstantiated, spontaneous reports will still fall short of true product stewardship for the industry. You have no mandatory requirements for manufacturers to supply information to the FDA, so it's still voluntary, and the industry hasn't come up with a program to ensure all manufacturers participate."

In a separate but related development, CFSAN has closed its consumer Web site and plans to launch a new site in 2004 that it said would be more beneficial to consumers.

Sandra Levy

 

Sandra Levy. FDA to launch ADR reporting system for dietary supplements. Drug Topics 2002;18:20.