As the dietary supplements and over-the-counter (OTC) medicines industries prepare to comply with a new law on serious adverse event reports (AERs), the American Herbal Products Association (AHPA), Silver Spring, MD, has requested a publication date for an overdue guidance document. That guidance was to have been published by September 18; the law itself goes into effect on December 22, 2007.
 
AHPA made its requests today in a formal letter to the Food and Drug Administration (FDA) and its parent agency, the U.S. Department of Health and Human Services (HHS). When it goes into effect the Dietary Supplement and Nonprescription Drug Consumer Protection Act will require that information on serious AERs associated with dietary supplements and OTC drugs be submitted to FDA. When a law is passed, the agencies tasked with enforcement issue guidance documents detailing how the law is to be put into effect. In the AER Act itself, the U.S. Congress required the Secretary of Health and Human Services to “issue guidance on the minimum data elements that should be included in a serious adverse event report as described under the amendments made by this Act.”
 
“Congress clearly intended that businesses would have at least 90 days to digest the FDA’s guidance and make any necessary changes to their staff or procedures in order be ready to comply with the law when it goes into effect,” said AHPA President Michael McGuffin. “As of today, we’ve less than 80 days, and the clock is ticking.”
 
AHPA also asked HHS and FDA whether, in the absence of clear guidance, FDA would exercise enforcement discretion if companies do not submit AERs as the agency wishes.
 
“There’s no question that the law goes into effect on December 22,” McGuffin said. “Companies are already preparing to submit any serious AERs they receive. However, it’s inefficient and confusing to establish a procedure that may change when guidance is finally produced.”