Senate Passes Dietary Supplement Adverse Event Bill

by Mark S. Senak



As the lame duck Senate gets ready to waddle off to their place in history, they have moved to pass S. 3546 - a bill that would require the makers of dietary supplements to report serious adverse events.

Interestingly, this development coincides with a lawsuit launched earlier this week against a maker of Fen-Phen.

The bill which passed yesterday, defines a serious adverse event as “reports of a death, a life-threatening experience, hospitalization, a persistent or significant disability or incapacity, or a congenital anomaly or birth defect.”

It remains to be seen whether or not this is the beginning of a broader reform movement aimed at the supplement industry, or perhaps will satisfy those hungry for reform. Likewise, if the bill becomes law, it represents another mandate on the FDA, to whom the SAEs would be reported that adds to the scope and therefore the expense of running the agency, increasingly reliant on PDUFA fees to do so.

While the bill is not yet law yet, one thing the supplement industry might consider is to get ahead of the law and begin reporting SAEs now, rather than being forced to later. This could be done either through an association, consumer group or a large manufacturer could take the first step. In any event, since reform is on the way, it might be a good idea to get as much ahead of the curve as possible.

_