Adverse Events Reporting and Supplements

From BioHealth Investor

by Mark S. Senak

As reported earlier this week, S.3546 – the Dietary and Supplement and Nonprescription Drug Consumer Act was passed by the Senate on December 6. Subsequently, on December 9, the House passed the Bill by a 2-1 majority. A few minutes later, the House adjourned, meaning it now awaits the President’s signature. The legislation was supported by the American Herbal Products Association.

The bill affects not only dietary supplements, but OTC products to report to the FDA serious adverse events associated with product use.

A manufacturer will be required to submit a serious adverse event report (SAE), defined as an adverse event that results in death, a life-threatening experience, in patient hospitalization, a persistent or significant disability or incapacity or a congenital anomaly or birth defect. An adverse event is defined as an event that occurs after overdose, abuse, drug withdrawal and failure of expected pharmacological actions of the drug. The report must be filed with the FDA no later than 15 business days after the report is received by the manufacturer, using the MedWatch form. This requirement pre-empts any local or state laws on the matter.

The bill will go into effect one year after passage, meaning that manufacturers of dietary supplements and OTC products have less time than that to prepare and design internal means of compliance. Retailers of dietary supplements whose name appears on the label may authorize the manufacturer to report SAEs for them. All labeling must reflect the fact that there is a domestic address OR telephone number through which a person may report an SAE, otherwise the product will be deemed mis-branded. For dietary supplements, that labeling provision goes into effect, but there will be a guidance issued to explain the data elements that would be included in an SAE.

Both the FDA and manufacturers should immediately set about internal infrastructure for this type of reporting.

What about consumer education? Nothing in the Act doles out responsibility for informing consumers about the new provisions. But without such education, how will consumers even be aware of their ability to report – by reading the label? Presumably, that will fall to consumer protection organizations, who also should start planning now.

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