Botox Off Label Use

>> Tuesday, October 6, 2009

In a somewhat stunning, and certainly proactive move, Allergan filed a suit against the FDA for banning off label use of Botox. The company is citing "free speech" as its argument. Bold.

When you cut through the clutter of the matter, what's really happening is that Allergan is in a Botox box. If they actively talk about off label use, then they have to provide data which comes under incredible scrutiny and potential penalties from the FDA. If they don't talk about off label use, then they still come under incredible scrutiny and potential penalties.

So what's a brand to do? Try to change the situation, even with the government.

I don't know enough about the brand and the data to say if off label use is right or wrong in this situation.  Off label uses of Botox include some pretty serious medical issues and also migraine headaches -- not just wrinkle reduction. 

But I do commend Allergan for putting themselves out there and taking a stand, even with the government.

You can read more about the situation in this Business Week article:

Hope this finds you well -- Jim.


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