Dietary Supplement Adverse Event Reporting—a 10-Year Perspective and Review
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It’s more important than ever that companies understand how FDA and the public view adverse event reports (AERs) and that they have a sophisticated system in place to monitor, report, follow up, and maintain consumer complaints and adverse events. On December 22, 2006, the Dietary Supplement and Nonprescription Drug Consumer Protection Act was signed into law. This law amended the Federal Food Drug & Cosmetic Act to require supplement companies to report serious adverse events to FDA within 15 days of receiving the report, and to keep records of non-serious adverse events for six years. Although the law has been in effect for nearly 10 years and remains unchanged, the industry still faces challenges with regard to how AERs are perceived and interpreted.
CRN embraced FDA's decision in December 2016 to make public data from FDA’s Center for Food Safety and Applied Nutrition’s (CFSAN) Adverse Event Reporting System (CAERS), calling it a demonstration of the agency’s commitment to transparency. However, the public availability of this data could increase a company’s risk of litigation if the data isn’t properly interpreted or put into context. In addition, a recent study in the Journal of Medical Toxicology misinterpreted poison control center data, providing an inaccurate picture of dietary supplement safety. This webinar will help participants navigate AERs with expert insights on key topics.
Webinar participants will:
- Receive a brief overview of the AER law and the requirements for dietary supplement businesses
- Hear FDA’s perspective on AER compliance and response
- Gain a better understanding of FDA’s increased attention to transparency and industry’s response
- Learn about the impact of poison control center data in context of AERs
- Receive practical advice and considerations for in-house AER compliance systems
Chief, Signals Management Branch, Office of Analytics and Outreach, Center for Food Safety and Applied Nutrition (CFSAN), FDA
Partner, Venable LLP
Rick Kingston, PharmD.
President, Regulatory and Scientific Affairs, SafetyCall International P.L.L.C.
Product Vigilance Manager, The Nature’s Bounty Co.
Rend Al-Mondhiry, Esq.
Associate General Counsel, CRN