By the Way – Botox Lawsuit one to Watch…
Botox is going through some interesting times these days. And though Botox users should be interested, the news is really of interest to everyone.
For one thing, the company (Allergan) is being probed by federal investigators in the USA for "past practices". This has to do with the sales and marketing of Botox. Has Allergan really followed the rules when marketing its product?
You see, there are strict rules in place when it comes to marketing a product. If it’s approved, you can promote it for that use, but not for "off-label" uses. For example, using Botox for migraine treatment is an off-label use. Commonly practised and legal, but not officially approved.
But Allergan is taking action itself (action which, it says, is unrelated to this investigation). It has filed a free-speech lawsuit against the federal government.
"Wait a second" the argument goes, "We need to be able to talk about off-label uses too. After all, we need to share safety information with doctors for these uses, and how the medication can best be used! After all, we have all this information…."
Well, that sounds great. But it would mean that, all of a sudden, drug companies could get their drug approved for one thing, and then promote it for everything… but of course, they wouldn’t do that.
This is a huge issue, because it involves a major philosophy of how drug marketing works in the United States. And as you know, big money is at stake.
Oh yes, and patients are important too.
It’s unlikely that regulations in the USA will suddenly and drastically change here, but everyone is watching for a change of direction – will this set a precedent? Or will this lawsuit simply give Allergan a little leverage in its other case?
Meanwhile, the news is out about positive Botox for migraine trials, and the news is also out about how much Allergan is spending wining and dining doctors and nurses in Australia, for example. Yes, big money. I hope in all the rhetoric the patients aren’t left behind.