Dietary supplements and FDA reporting compliance: The adaption of an existing SAE reporting system to new corporate needs

Kowa Company Limited (KCL) is a multinational company based in Japan which globally markets several health-care products, including prescription and OTC pharmaceuticals and dietary supplements.

In 2009, KCL entered the prescription pharmaceutical market in the USA with its flagship HMG-CoA inhibitor Livalo® (pitavastatin tablets) by purchasing a small regional company which it renamed Kowa Pharmaceuticals America, Inc. (KPA). An Adverse Event (AE) reporting system for reporting to the FDA was installed and KPA was staffed as a fully operational AE reporting group.

In 2012, a decision was made to launch a line of dietary supplements in the USA and Kowa Health care America (KHA), Inc. was established in Torrance, CA. Keeping costs for this start-up to a minimum was desirable and KPA was asked if it could implement the FDA required Serious AE reporting system for dietary supplements.

Reporting of the serious AEs for dietary supplements is different from prescription pharmaceuticals. We therefore modified our existing processes to accommodate the required dietary supplement process. In this presentation are outlined the steps taken to bring the dietary supplement AE reporting system in the initial instance, and how our procedures were modified to accomplish compliance with FDA Dietary Supplements AE reporting regulations and guidance.