 | Register Now! | | |
|
Want to post to the discussions? Comment on a Blog? Register Now.
|
|
|
| NPI Community Blogs | | |
|
|
|
|
|
|
Location: Blogs Jim Lassiter -- Good News/Bad News |
|
| Posted by: jim |
4/25/2008 3:13 PM |
One of the members of the entity we like to call "Big Pharma" just sent a citizen's petition to FDA. This has the potential affect roughly the size of a small nuclear device on this industry. Want to find out more? Read on.
That sound you might have heard was that of a contained nuclear explosion. Didn’t hear it? Well you weren’t paying close attention. Here’s what the detonation entailed.
One of the primary “Big Pharma” players (you know – those guys we in this industry are always paranoid about) in concert with some other folks we have had a hard time getting aligned with (the American Dietetics Association) have teamed up with a couple of other groups to send a petition to the FDA. Hmmm. What does the petition request? In simplest terms the request is have FDA rule that weight-loss claims are de facto drug claims. Nothing to worry about right? There would have to be a rulemaking process right? Shouldn’t be anything we, as an industry, cannot over come, right?
Three wrongs and you’re out. Here’s a different way of looking at it. The FDA has historically (and without challenge I might add) considered certain claims that do not necessarily include one of the “five magic words” to be drug claims. Most especially these claims involve the terms: cholesterol, blood pressure and blood sugar. There has been exactly zero rulemaking on these matters and yet unless the claims are specifically worded as FDA wishes, any claims using these terms are considered drug claims. This industry has allowed the ruling to remain unchallenged. In response to the question of “what harm could this cause?” we have the GlaxoSmithKline petition.
No rulemaking process is required. All that is necessary is the next round of structure/function claims to be submitted and have one or two of them contain weight-loss claims. FDA would then issue “Courtesy Letters” disallowing these claims. This puts them on record. Additional reviews of labeling for products by FDA would result in Warning letters issued and PRESTO: the non-rulemaking- rulemaking process is complete.
A reading of the petition itself makes a solid case. Please rest assured that the folks who put this together know what they are doing. The petition cites specific examples of materials sold in dietary supplements that make claims beyond the credible limits of substantiation. Moreover, they are not asking for any rulemaking procedure, only that FDA respond to the petition and act accordingly.
If this industry should decide that the outcome of the ruling isn’t nice, we cannot turn to Congress, where Congressman Waxman sits waiting to pounce on the industry. He has already requested that FDA stop reviewing “qualified health claims” and apply the funds associated with that activity toward enforcement. Now, let’s add to this little toxic stew the matter of a pharmaceutical company and all of its resources (albeit with an axe to grind since Glaxo makes Alli but acting in concert with “independent” organizations) asking favors of FDA. FDA is obliged to respond to the petition. We as an industry are not. However, if we do nothing (as we usually do) the field of claims will likely narrow once more. This common thread is one I particularly have railed against for years. Still, the field of allowable claims just keeps getting smaller. This post is a simple call to awareness, since asking for action is not likely to result in anything. At least we can expend our efforts as we might best do: "Furiously monitor" the situation. Hopefully we will do more.
|
| Copyright ©2008 Jim Lassiter |
| Permalink |
Trackback |
|
|
|