As Dan Fabricant, Director of the FDA’s Dietary Supplements Program, states in recent communications with Industry, he views the level of non-compliance of dietary supplement manufactures with cGMP’s (current good manufacturing practices) as astonishing. Based on audits that have been completed by the FDA’s compliance division they have estimated that nearly 70% of dietary supplement manufacturers are currently not up to par with cGMP. He also indicated that FDA has concerns regarding under-reporting of adverse events based on what they have seen from their audits. And, given the level of issues regarding cGMP compliance, FDA is concerned that some of the cGMP issues could give rise to adverse events.
Dr. Fabricant acknowledges that substantial progress has been noticed, but many of the same compliance mistakes are being repeated. There are likely a number of reasons for under-reporting. Some Manufacturers that fail to report their adverse events simply do not realize that an adverse event is defined by legislation as “any health-related event associated with the use of a dietary supplement that is adverse”. That’s a pretty broad definition. Dr. Fabricant also noted that another issue manufactures are often deficient in is failing to provide consumers with an address or phone number to call to report an adverse event, so if something were to happen they would be able to contact the manufacturer and let them know. He added that some manufactures have listed the FDA’s MedWatch phone number for consumers to call instead of their own, which he said is strictly prohibited and does not constitute compliance with the regulations. Considering that cGMP compliance and safety surveillance including AE reporting are in the top three FDA initiatives, it is worthwhile for manufacturers to review their systems and process’s to insure that they ready for the next FDA visit or audit.
Read Dr. Fabricant’s article for more information or feel free to contact me with any questions or information on how SafetyCall can help your company put in place “Best Practice” solutions to meet all aspects of the regulations.
-Rick Kingston, PharmD