05.01.03
The American Herbal Products Association (AHPA), Silver Spring, MD, recently filed a Citizen Petition with FDA recommending that it establish, through rulemaking, a requirement for marketers of dietary supplements to communicate to FDA serious adverse events reports (AERs) associated with dietary supplements. The petition specifically requests that new rules, modeled on the current rules for mandatory reporting of AERs associated with drugs, be added to the Code of Federal Regulations (CFR). The proposal includes provisions that assure that the same protections against disclosure of reports that are now the norm for drug companies would be provided for manufacturers of dietary supplements. AHPA’s petition also emphasized the need for equal treatment of supplements and other products regulated by FDA, noting, “AHPA is concerned about FDA’s practice in the past to make summary adverse event reports available on its website for dietary supplements but not for other regulated products. For example, such summary reports are not made available by FDA for prescription drugs. And there is no system at all for adverse experience reporting for nonprescription drugs that are not new drugs. AHPA object[s] to a system that provides prompt access to information regarding supplements, while such information regarding other regulated products is far less accessible.”