The reporting of adverse events (AER) by manufacturers, packers, and distributors of dietary supplements in the US was signed into law on December 22, 2006, with compliance effective one year later.
Despite initiatives such as the FDA’s MedWatchPlus web portal, there have been questions raised about how the industry is performing.
A report by the US Government Accountability Office (GAO), which can be accessed here, showed that the Food and Drug Administration (FDA) received 6,307 AERs from 2008 through 2011, with 71% of these coming from industry for serious health problems. The majority of these reports were for multi-component supplements.
The GAO report added that the actual number of AERs is thought to be higher since poison control centers received over 1,000 more reports of adverse events for dietary supplements during the period 2008-10 than FDA.
In addition, the AERs correspond to only 257 companies, a number which is “much lower than the estimate 4,000 dietary supplement firms in existence”, noted Dr Kingston, who is President of Regulatory & Scientific Affairs for SafetyCall International. Not only that, but there are an estimated 55,000-85,000 products on the market.
“Adverse events have been under-reported,” he said.
There is also a GMP angle to the debate, with the agency recently stating that 70% of dietary supplement companies have GMP deficiencies, which suggesting that this non-compliance contributing to adverse events due to manufacturing issues.
The GAO report acknowledges that FDA inspection results from 2008-12 identified 20 problems related to AER requirements during inspections. In three instances, the firm did not submit a mandatory AER within the required 15 days. For the other 17, the Agency found that a firm did not submit a mandatory AER at all.
A unique opportunity
While some may see this as more negativity about the industry, Dr Kingston says firms should view it as “a unique opportunity to monitor how consumers view a product.”
“There are positive things that can happen with adverse event reporting,” he told us. “We can take things in the right direction right now, and instill in the consumer and the healthcare professionals the confidences they need.
“Look at pharma: When a consumer knows a company and a drug, then they have the confidence that what is supposed to be in a particular pill is in there. We need to give consumers the same confidence in dietary supplements. The goal is that people will not talk about quality concerns.”
“You need to ensure you have the right system in place.”
“The best-practice companies will take any allegations very seriously, and will be in touch with consumers,” he added. Dr Kingston explained that there are four parts to the process: Receiving, documenting, tabulating, and submitting.
One of the issues with AERs is that companies need to do a better job of communicating the risk-benefit. The benefits are related to the health and wellness, but companies thinking that there will never ever be a problem are setting themselves up for failure, he said.
And this is where services like SafetyCall can help. The company describes itself as “a multidisciplinary healthcare firm focused on providing manufacturers services in the area of post-market medical surveillance, product safety, and regulatory reporting support for adverse events”.
By implementing a robust surveillance system a company will be in a much better position to identify what went wrong, he said.
Having customer service personnel document AERs is not right, added Dr Kingston. AERs are a give-and-take relationship.
“Consumers are looking for re-assurance, so it’s important to have medical folks to differentiate that out. It’s about moderating the safety and the consumer response.”
“Look at it that way and you’re being a good steward of your product.”
And sorting the wheat from the chaff is important, he said. “By and large, for every 100 AERs there are probably one or two that signal an issue that a company needs to take a look at.”
“There is a lot of background noise. People take these products as part of their lifestyle, and in middle-aged and older Americans it’s about maintaining health. But things happen in those age groups. When you have a problem, there is a natural tendency to think about the product you took that morning.
“The FDA recognizes, and companies need to, too, that there is a lot of background noise.”