AHPA tackles new adverse events reporting system
FDA on the agency's new adverse event reporting system. In a
letter, the trade association pointed out the inconsistency of
consumer access to the FDA's reporting systems, noting that access
to reports about dietary supplements has been readily available
while similar information about other products is not.
The American Herbal Products Association (AHPA) has submitted comments to the Food and Drug Administration (FDA) offering recommendations on how to make the agency's new adverse event reporting system for dietary supplements work better than the now defunct Special Nutritional Adverse Event Monitoring System (SN/AEMS).
AHPA members were alerted on August 29, 2002 that the FDA's Center for Food Safety and Applied Nutrition (CFSAN) was to develop a new system for tracking and analyzing adverse events reports involving foods, cosmetics and dietary supplements. The new system, called the CFSAN Adverse Events Reporting System, or CAERS, replaced the often criticized SN/AEMS on the same date.
"AHPA has recently taken a strong position in support of requiring manufacturers to provide FDA with any reports of serious adverse effects they receive from their customers," said Michael McGuffin, AHPA's president.
"Our timing in adopting this position is predicated upon FDA's commitment to replace their old system with one that actually functions properly and is not a liability to industry. We intend to be actively involved in sharing our ideas to assist the agency in achieving this goal."
The AHPA directed its comments in a letter to Dr Kenneth Falci, director of the Office of Scientific Analysis and Support at CFSAN and responsible for implementing CAERS. It suggested that the FDA consider making certain information on reports received from consumers obligatory, and recommended that disclaimers clearly stating the nature and quality of the reports in the system are provided.
The trade body also questioned the usefulness of classifying reports by every ingredient in a product and challenged the agency to design CAERS in a manner that allows correction or removal of any report that is later found to contain gross errors.
The AHPA also identified a concern about the lack of consistency in consumer access to the FDA reporting systems, noting that access to reports about dietary supplements has been readily available while similar information about other products, specifically over-the-counter drugs and old drugs and new drugs, has not been readily accessible to consumers.
"The letter to Dr Falci stated AHPA's opposition to any continuation of this uneven policy and recommends that the best solution is not to remove consumer access to reports of adverse events associated with dietary supplements, but rather believes that adverse events associated with all classes of products regulated by the FDA should be readily available to consumers."
The full text of the letter can be found at: http://www.ahpa.org/Falci.pdf.
The CAERS system is expected to be pilot tested this year and to be operational by May 2003. In the meantime, CFSAN's internal adverse event collection and evaluation systems will continue to operate.
