By Len Monheit
With a huge sigh of relief and smiles of victory, industry leaders and lobbyists finally allowed themselves to celebrate the weekend, having just heard that the U.S. House of Representatives had passed Senate bill S3546, the "Dietary Supplement and Nonprescription Drug Consumer Act," requiring manufacturers to notify the Food and Drug Administration (FDA) of all serious adverse events for dietary supplements and over-the-counter drugs (OTCs) reported to them.
This outcome was in serious jeopardy, despite the fact that all industry trade associations were actively supportive, despite the fact that certain consumer groups such as Citizens for Health, had mobilized their resources and voice in support of this legislation, despite the fact that this was one issue that Senators Hatch and Durbin had reached consensus on, and despite the fact that in a Democrat-led government, industry’s prospects for friendly legislation would be severely hindered.
The smiles are certainly justified and kudos in order to all the trade associations and others who were so active in understanding the potential peril of the situation, and in taking aggressive leadership to ‘get this done’ in the current session. Delay could have meant failure, and being in Washington last week gave me personal insight into just what can be accomplished through solid communication and a commitment to collaboration, a focus on getting the job done, and a clear understanding of the implications of both inaction and action. Of note was the strong alignment between industry and consumer groups such as Citizens for Health, an alignment perhaps not so strong since the passage of DSHEA some twelve plus years ago. It is this type of alignment that provides a sign that a proactive strategy, based on this alignment and communication, might assist the industry in executing on the generally favorable legislative environment it has over the years seen created.
Retreating into history, one must acknowledge that this alignment (industry itself and industry and consumer) failed to a large extent after DSHEA was passed. Sure, there were other failures too, but the implementation of DSHEA has been flawed, and not only from an FDA standpoint. Industry has not done what it needed to in order to ensure a marketplace of high quality, scientifically substantiated products, and consumer behavior has not demanded this consideration. Sure, access to a broad range of products is extremely desirable, but at what standard, what minimum criteria?
Let’s move back to this past week’s success, accomplished over numerous hurdles such as apathy (industry and legislators), resource limitations, and perhaps most significantly, the perspective, voiced frequently, of a divided industry. It is ironic that all trade associations were strongly in support of this legislation, presumably expressing the voice of the industry and thousands of company members, yet, some (thankfully not enough) were able to argue effectively against this bill, and to present themselves as industry spokespeople, representing a not insignificant percentage of our industry. In many cases, in fact, the companies upon whom the burden of compliance would ultimately fall, were solidly supportive, while some individuals, presumably, the recipients of a serious AER reporting mechanism attesting to general supplement safety, advocated against the proposed system. In their partial defense, some were supportive, but felt that the proposed legislation was flawed, and hence positioned themselves as opposed.
This perspective of a divided industry is one that we observe frequently, and it underscores conflicting objectives and agendas. From ‘sell at all (any) cost’ to ‘let’s invest in research’, the range of belief systems we find as we walk through the sector can be quite extreme. There are those that obviously believe, by their very actions, that placing product in the market is an entitlement and not a responsibility. Until these individuals and companies accept the responsibility, inherent with producing products for health and wellness (and primarily for ingestion) we’re going to have fundamental differences, appear to be divided, and to a certain extent, to be choking on our own success.
I certainly do not want to take the wind out of deserved sails over last week’s solid victory and accomplishment. Let me say again that the efforts of the various groups who called in resources, and argued, persuaded, called, faxed and wrote should be congratulated.
I feel I must caution though that perhaps we should be extremely cautious in describing as an end game, what should really be a milestone, a waypoint, in an ongoing battle. While DSHEA was a victory, it was not the end of a war, and similarly, a mechanism and responsibility for Serious Adverse Event Reporting is significant, it allows us to note how we ARE regulated, it will presumably allow us to prove supplement safety, and it partially offsets the argument of an industry filled with irresponsible renegades.
On the other hand, how this legislation is implemented, the context in which information is presented, and industry’s actions now, are all equally critical. To sit back and say, “all right, we’re over the hurdle now” would be catastrophic. The momentum, communication pathways, relationships and goodwill and recognition of responsibility that this exercise has generated should all be leveraged into the industry strategic plan. Perhaps voluntary compliance ahead of schedule is part of that strategy, with announcements to that effect. Perhaps other initiatives like SIDI, aggressive advertising enforcement, more transparent information about questionable supplier or buying practices, along with better ways to identify good and other companies are part of the mix. Of note, the United Natural Products Alliance is holding an AER seminar January 11, 2007 in Salt Lake City, (AER Seminar - Part 3: Anticipating and Implementing Federal Legislation) an event that takes on a whole new relevance and context.To perhaps summarize, industry got (and deserved), its holiday present this year. Let’s enjoy it, but like any present, if left unused in a closet, it has no lasting value – and the goodwill fades.