Adverse events reporting may not quell critics

The issue of requiring manufacturers to report adverse events to the US Food & Drug Administration has been a hot topic in the nutraceutical industry as companies want to assert their credibility in light of media hype surrounding a perceived complete lack of regulation in the industry.

Rick Kingston, president for regulatory affairs at SafetyCall International, outlined how manufacturers will have to treat such reports thoroughly, but not without a degree of suspicion.

SafetyCall provides poison control and product safety call center services for manufacturers of drugs, dietary supplements and consumer products. Unlike for drugs, by law adverse events for dietary supplements are not required to be reported, but this looks set to change.

In June, a bill was introduced that would amend the Food, Drug and Cosmetic Act that would oblige supplement manufacturers, packers and distributors to notify FDA of any serious adverse events reports.

Senate bill 3546, would require supplement labels to include a telephone number for the reporting of serious advert events, and require supplement companies to pass on these reports to FDA within 15 days.

But Kingston insisted the manner in which these events are reported and dissimulated will dictate their potential for doing more good than harm.

"Non-substantiated and spontaneous adverse events reports were what killed ephedra,"​ said Kingston, referring to the herbal ephedrine which was banned by FDA following reports of several serious adverse events, including the death of a young professional baseball player.

Along these lines, Kingston finds fault with the fact that according to a committee report on adverse events, the party reporting the event does not have to identify themselves.

"I have never seen this before,"​ said Kingston. "And I find it worrisome."​

Paradoxically, according to Kingston, the bill does call for a penalty for fictitious reports.

In order for reporting on adverse events not to balloon into the hysteria that could result in an out and out ban on a herbal or supplement, Kingston suggested manufacturers need to be better informed as to the potential impact of substances on physiological systems and whether or not it has drug interactions,

Other limitations Kingston highlighted surrounding adverse events reporting are how manufacturers should classify the severity of a reaction, as well as how they should assess whether a product was in fact the cause of a reaction.

"Is this going to be fodder for critics?"​ asked Kingston. "It's going to depend on how we carry it out."​