The Center for Food Safety & Applied Nutrition's Adverse Event Monitoring System will be supported by approximately $2.5 mil. in FY 2000 funding as well as by an outside contractor in the process of being hired, center Director Joseph Levitt testified at a May 27 House Government Reform Committee hearing on CFSAN's monitoring of dietary supplements.

The FY 2000 budget includes $15.3 mil. for "injury reporting" for FDA ("The Tan Sheet" Feb. 8, p. 17). In the request, the funds would partly go toward hiring 11 new full time employees.

In his testimony, Levitt noted $2.5 mil. of these funds would be used to "enhance the adverse event monitoring system within the foods program. Most of these funds would buttress the report- ing system for dietary supplements, as these products comprise the largest share of the center's" adverse events.

"If these funds are provided, "Levitt continued, "we would hire several additional clinical staff to review the [AE]s, and we would develop a system to integrate adverse event reporting and to modernize it for our entire center program." Levitt noted a modernized system would be compatible with others at the agency; he also said his staff is determining its AE funding needs for its FY 2001 budget request.

In response to concerns expressed by committee Chairman Dan Burton (R-Ind.) regarding the time lag between when an AE is posted and when FDA contacts the affected company, Levitt said CFSAN is hiring "an outside contractor" to help with the process.

"What we tried to do was to have people on staff" take care of Freedom of Information requests "when they had time," Levitt said. "What happened was they never had time." To remedy the problem, CFSAN decided to hire a contractor, and the center is "in the process of training that contractor. We're being sure that there is somebody dedicated to that task," he added.

The FDAer pointed out it will still take time to catch up with the number of requests that have been filed, but he agreed "industry's complaints...are correct. They need to have the information too, they need to be part of the solution." Levitt promised to submit a report on the contractor and its responsibilities to the committee as soon as training is completed and it begins handling the FoI requests.

The center director also answered several more general questions regarding the AE Web site. Responding to Burton's concerns that AEs are posted on the site without ever establishing whether the listed products actually caused the reported symptoms, Levitt said that is a "misconception."

"Medical staff review reports, that is a very important part of what they look at." The real problem, Levitt maintained, is there needs to be "greater transparency in understanding of the process that we have."

However, Levitt noted "the Web site is misunderstood for what it is intended to be." Rather than providing a comprehensive review and analysis of every AE, the site "is nothing more than a table of contents of reports submitted to FDA."

Each AE listed is "just one line across the page that is taken verbatim from the report that comes in even before there is an evaluation done. That originally, as I've come to understand it, was the censor's way...of cataloguing what came in and then following through and doing more detailed review," Levitt said. The problem that has subsequently arisen, he admitted, is that after posting the abbreviated report, CFSAN does not "make the underlying report available to the manufacturer for a very long period of time."

Answering a question regarding how CFSAN defines a serious AE, Levitt quoted the MedWatch database criteria, saying, "We would consider 'serious' as follows: when the outcome is death, is life-threatening, requires hospitalization or prolonged hospitalization, causes disability, congenital abnormality or requires intervention to prevent permanent impairment or damage."

Levitt noted that with ephedrine-containing supplements, although only 30% to 40% of AEs have been deemed serious, it is still "a large enough number that it is a concern to us." Levitt told the committee CFSAN receives roughly 500 dietary supplement AE reports annually, and the center estimates the number of AEs reported represent only 1% of the total number that have occurred.

CFSAN AE Monitoring System To Receive $2.5 Mil., Contractor Help - Levitt

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