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Location: Blogs Jim Lassiter -- Good News/Bad News |
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| Posted by: jim |
5/2/2008 12:52 PM |
The latest evidence from the actions of a pharma company should give one pause. There is a legitimate danger ahead and we need to be more than naïve about the future. If you think restrictions on weight loss claims would be bad -- what about restrictions on CALCIUM claims?
Let’s review for a moment. Recently there was a citizen’s petition filed requesting that FDA consider all claims for weight loss drug claims. The petition filed is very compelling and exceptionally well done. The beauty of this request, as I expressed in an earlier post, is that there is no need for a rulemaking process at all. All that is required is for FDA to respond in a positive manner. As with cholesterol claims, blood pressure claims and blood glucose claims there is no need for rulemaking in order to disallow claims.
Let’s review a bit more. The regulatory scheme in the United States is simple: You are what you claim. Hmm. Thus if you restrict entire classes of claims to a specific class of goods (say drugs for example) you eliminate any opportunity for other industries to make such claims (say the dietary supplement industry). Are you with me so far? Good.
If weight loss claims become exclusive to drugs, that should make things rather challenging for a host of members of this industry. Overall we as an industry are heavily reliant on revenues generated from weight loss products. Eliminating the ability to make such claims would vastly undercut the overall market for our products.
What could be next? Well, how about this. FDA’s chief spokesperson to the dietary supplement industry (The Good Dr. Frankos) recently discussed the newly implemented AER system fro dietary supplements and what the agency has learned thus far. He expressed a bit of surprise at the sheer number of AERs received thus far but more importantly elucidated the primary contributors. Chief among these were AERs for Os-Cal the calcium supplement marketed by GlaxoSmithKline (GSK). So what? GSK is likely more conservative in determining what constitutes an adverse event than many other companies in the dietary supplement industry owing to their long history of experience with AERs from their drug products. It’s likely that this conservative approach comes from that experience and there is nothing to worry about. Oh yeah?
Let’s think about that for a minute. The petition filed concerning weight loss claims was presented by a group of organizations inclusive of the American Dietetics Association and (guess who) GSK. Remember that GSK has a vested interest in the weight loss market. They make a product called Alli. You may have heard of it. I won’t speculate as to additional motivation regarding the claims restriction in the weight loss category but there is one clear winner should such a restriction occur: GSK.
Now let’s return to the AER situation. It seems that there are a large number of dietary supplement AERs coming in from GSK. These are centered on their calcum supplements. What possible link can there be? Try this: GSK is a primary benefactor from the sale of a currently-prescription-only product called Boniva. This product is a preventive of osteoporosis. Sound familiar? If suddenly the claims regarding calcium supplements and osteoporosis were removed, who benefits? Sounds a lot like GSK and Roche would with Boniva. Like the slogan for the product says “There’s only one”. But, there’s already an approved health claim for calcium and osteoporosis right? Overturning this would require some form of regulatory activity but that is far from an insurmountable obstacle for a company as well-versed in regulatory matters as a drug company is. GSK would lose out on its calcium supplement franchise, right? A small price to pay. Besides, if calcium claims were restricted to drugs, well, GSK also makes Tums. You know: an OTC that coincidentally provides a large amount of calcium. GSK could move the calcium claims to that product and no one would be harmed. At least no one at GSK.
There is real evil in the world whether we choose to believe it or not. This does not mean that GSK is evil. It means that the dietary supplement industry is better served when it is not foolishly naïve and recognizes that there are corporate entities with significant resources that would very much benefit from a diminution of the dietary supplement industry. Without such recognition we are, as an industry, destined for extinction. To believe otherwise is to take naiveté to new heights.
We have allowed the claims field to become narrower and narrower with each passing fiat while not lifting one finger to stop the trend. This inaction allowed notable momentum and significant precedent (as specifically cited in the GSK petition on weight loss claims) to build. The dietary supplement industry, with the aid of its trade associations (NOT the trade associations alone acting as surrogates) MUST stand up now or face the inevitable.
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| Copyright ©2008 Jim Lassiter |
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