FDA should help firms investigate adverse events, says CRN

The Council for Responsible Nutrition (CRN) on Tuesday highlighted the importance to industry of being able to access detailed information on the reporting of adverse events. According to the group, this would help dietary supplement manufactures conduct their own investigation of the circumstances behind an adverse event reported to be linked to their products. To this end, CRN urged the Food and Drug Administration (FDA) to consider the inclusion, on adverse events reporting forms, of a disclaimer by the consumer authorizing the treating physician to speak with trained company representatives in order to communicate more detailed information on the reported side-effects. Resources ​ "​Irrespective of Federal adverse event reporting requirements, most, if not all​ manufacturers of dietary supplements will attempt to conduct their own investigation of the circumstances behind an adverse event reported to be linked in some manner to their product(s),"​ wrote Dr Andrew Shao, VP of scientific and regulatory affairs at CRN. "This process is particularly resource intensive, especially when information pertaining to the original case report is incomplete or insufficient to enable the manufacturer to conduct its own investigation." ​ Dr Shao's letter came in the form of FDA-solicited comments to a notice published in the Federal Register on February 15 2008. Docket No. FDA-2008-N-0077 calls for comments on information collection processes, specifically in regards to MedWatch Forms 3500 and 3500A. These are the forms used for reporting adverse events and other problems associated with FDA-regulated products. According to CRN's proposal, a disclaimer on these forms would be accompanied by a check mark box, which a company's customer service or complaint representative could mark after soliciting permission from the physician or patient reporting the adverse event. Web-based reporting ​​In light of FDA's intended transition to an electronic or web-based submission system, CRN also suggested that the agency allow for the inclusion of attachments that may be submitted with the serious adverse event report. AER bill ​​The Dietary Supplement and Nonprescription Drug Consumer Protection Act - also known as the serious adverse event reporting bill - was signed into law in December 2006 and came into effect one year later. In the architectural stages, it had strong support from many in the industry, who saw it as extra post-market precautionary measure to secure more credibility for supplement makers. The FDA issued two draft guidance documents on the law on January 2, which it said were intended to assist the industry. However, last month CRN sent comments to the agency, requesting it to withdraw its guidance on the labeling of dietary supplements on the grounds that this is unnecessary and potentially misleading for consumers. According to CRN, the "recommendations"​ made by FDA in its document are an attempt to impose new labeling changes through guidance rather than through notice and comment rulemaking. This, it says, places manufacturers in a compromising position in the event that they do not follow the recommendations. It also misleads consumers as to the safety of products, and it places a "significant economic burden"​ on companies needing to change their labels. The American Herbal Products Association (AHPA) also submitted comments under the 90 day comment period, saying that FDA has no statutory requirement to issue the guidance. It was only required to issue guidance on the minimum data requirements to be included on a label - and that obligation, according to AHPA, was already met in earlier guidance issued in October 2007.