FDA planning new adverse-event reporting system for food, supplements

Sep 13, 2002 (CIDRAP News) – The Food and Drug Administration (FDA) says it is taking several steps to improve the monitoring and analysis of adverse events related to food products, dietary supplements, and cosmetics.

The FDA's Center for Food Safety and Applied Nutrition (CFSAN) announced it is working on a single adverse event reporting system that will replace separate systems for the three categories of products.

In addition, CFSAN will be notifying companies by letter when it receives reports of adverse events involving a company product. That practice will begin "on or after" Sep 16, the agency said. Companies will also get a copy of all adverse event reports, minus any information that would identify the consumer.

CFSAN also is studying how to share adverse-event data with the public on a user-friendly Web site, officials said. A CFSAN site that provided some information on problems with dietary supplements was recently shut down because it was difficult to use, the agency said. Plans call for eventually setting up a new site that will provide adverse-event information on food, food supplements, and cosmetics, said CFSAN spokesman Sebastian Cianci.

The various steps are intended to meet several needs, Cianci told CIDRAP News. "We want to speed review of adverse events through a single electronic system, prevent further injury by sharing information with firms, and be responsive to consumer protection efforts," he said. "Most significantly, this will speed our response to products of concern." He said the measures were not prompted by any particular event or product-related problem.

The new tracking system, called CFSAN Adverse Events Reporting System (CAERS), will increase efficiency, Cianci said. "It’s something we started designing back in 2000. We wanted to consolidate our scattered systems and better track dietary supplement adverse-event reports." The existing separate systems for food, supplements, and cosmetics "have trouble talking to each other," he said.

Testing of parts of CAERS is under way now, and plans call for full operation of the system by May 2003, Cianci said. Meanwhile, the existing systems remain in use.

People who want to report an adverse event should call their local FDA office, Cianci said. Phone numbers for local offices are available on the agency Web site (www.fda.gov). Product-related emergencies should be reported by calling the FDA at301-443-1240, he said.

"We're looking to improve the whole process completely," Cianci added. "If we can improve the way reports are received, we'll address that as well."

In an Aug 29 letter to stakeholders, the FDA said that notifying companies of adverse events by letter "allows FDA to share its knowledge of an event concerning a company's product." Cianci said he wasn’t sure how CFSAN has notified companies of adverse events up till now.

Cianci said that work on a new Web site to share adverse-event information with the public probably won't begin until fiscal year 2004 (which begins in October 2003). Until a Web site is available, the public can get information by filing freedom-of-information requests, he said.

In the fiscal 2002 budget, CFSAN received $3.5 million for adverse-event monitoring and analysis, Cianci said. This included $2.5 million in the original budget and $1 million that came later in supplemental funding for bioterrorism preparedness. The agency also received $1.5 million or $2.5 million in fiscal 2001, he said.

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