Editorial: AERs - Near Term Considerations

By Len Monheit

As most of you know by now, in an eleventh hour development (actually 27th for those keeping track – 3am in the morning on December 9th and about 7 minutes before Congress officially adjourned for the session) the Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006 was passed with a very slim margin of victory. Credit for this successful passage is shared by the associations and companies who were vigorous in their support and specifically as well, to the American Herbal Products Association (AHPA), the first trade association to sense the need (or inevitability) of the move to a mandatory serious adverse event reporting environment.

With this legislation now a reality, industry and others can turn to interpretation and implementation, assisted in large part by the 26 page Committee Report, which presumably will form a core resource for the FDA’s preparation of guidance for the implementation and enforcement of this legislation.

This past week, I had the opportunity to attend the first of the post-pass events on AERs, hosted by the United Natural Products Alliance (UNPA). Approximately 140 attendees and participants discussed aspects of the law itself as well as issues regarding interpretation, implementation, strategy, challenges and opportunities. I’ll be writing in upcoming weeks in more detail about the substance of this event; in this piece, I’d like to focus on a few of the ‘issues’ and discussion points which arose in the highly interactive session.

First of all, many of the attendees became at the least ‘thoughtful’ when told that under the law, while they were obligated to report ‘serious’ adverse events to the FDA within 15 days (and there is a definition of what constitutes ‘serious’, although some interpretation and judgment will apply), companies were obligated for collecting and maintaining the records (for six years) for all adverse events.

It is quite clear that no one really knows the volume of serious adverse events likely to be reported, let alone the total number of adverse events likely to occur. What is evident is that, as evidenced by last evening’s CBS news feature involving author Dan Hurley, which called into question the issue of supplement safety, reporting also on Poison Control Center ‘data’ indicating many thousands of supplement-related adverse events, the issue of real supplement safety will be the subject of much dialogue in upcoming months and years. The absolute number of serious adverse events reported to FDA will certainly be one yardstick, the number positively attributed to dietary supplement cause – another.

One can certainly surmise that the presentation of data in context or relative sense is not going to be a media or FDA priority, and so must therefore be an industry responsibility. What is unclear at this point is who (from industry) will take on this over-arching responsibility to allow proactive demonstration of relative supplement safety. At the UNPA seminar, Dierdre Allen of content provider NHI OnDemand informed the audience of the animal (pet) care environment where a third party monitoring service (National Animal Supplement Council) holds the data on adverse events per dosage, specifically 2 adverse events in 1.5 million doses of glucosamine products as one data point. Gathering and managing this type of information, by product, and by category, should be a priority, as the new law takes effect next December.

It is obvious that the management and presentation of this and other data is bound to be a contentious issue. One of the principal arguments against the legislation in the first place was the fact that many issues would be attributed to supplements when the actual cause was either unclear, complicated or obviously not supplement related. The presentation and discussions at last week’s seminar delved into this issue. Presenter Dr. Rick Kingston, President of SafetyCall™ International, contended that unlike drugs, where practitioners would likely be the source of many of the adverse reaction reports (especially the serious ones), in the case of supplements, it would be consumers that would be the primary source. Whether or not this is to be the case, one thing becomes absolutely crystal clear. Never has it been more imperative that industry, despite obvious obstacles, actively engage practitioners in education, dialogue, debate and other interactive forums so that there is a mechanism for information exchange and hopefully (ideally) a broadening of the knowledge of interactions (known and predicted), relative safety profiles, scientific substantiation and other factors related to supplements. If physicians are to be involved in the reporting process, (and they will) any tools and resources we make available, any discussions we begin, any education we provide will be useful in managing our new environment and reality.

Tools and resources also need to be made available to the industry itself. This includes FAQs, precautionary text on labels, interaction data, expertise in the management and interpretation (and definition of) ‘serious’ and ‘other’ adverse events. Companies obviously, if they have not already done so, must make a determination on how to build and manage their system of adverse event management and reporting, in-house or outsourced. Although many industry leaders might be pretty much compliant, there are undoubtedly some issues of the new law that will require system and process changes and expansion, even if only to handle label changes eventually required under the law. For those that have no current system, fundamental decisions are necessary.

UNPA chose its seminar presenters well. The afternoon presentations at the whole day seminar focused on two elements that likely will become lightning rod issues – Interactions, presented by Francis Brinker N.D., and Stimulant-Based Dietary Supplements, presented by Dr. Christine Haller. It is in these areas that one can almost certainly expect the most attention, and perhaps, the bulk of adverse events attributed to dietary supplements.

The audience this past week did include a few companies from outside the United States. This is appropriate, as these companies too, have obligations under the Act. In fact, it can be argued that these companies may have as much or even more at stake. As UNPA Executive Director Loren Israelsen notes: “Section 5 of the Dietary Supplement and Nonprescription Consumer Protection Act provides that all dietary supplements being imported or offered for import into the U.S. must comply with this act. If the FDA becomes aware that such products are non-compliant, they shall be refused admission into the United States and will not be allowed readmission until the responsible party submits an application to the Secretary of HHS with notice to the Secretary of the Treasury for authorization to take action to assure that the importing party is in compliance with this law. This application will include filing of a bond as well.

In short, it becomes particularly important for all importers of dietary supplements into the United States to be aware of and comply with provisions of this new legislation. Failure to do so may result in the products being refused entry and being forced to go through a reapplication process which will include the posting of a bond. “

Those that assumed that passage of the law would be the end of the process were obviously being naïve. It is a milestone true, and both an opportunity and a challenge. It is incumbent on industry to continue to push and manage, as much as it can, both the process of implementation as well as the results of the Act itself.

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