The Cross-Border Biotech Blog

Biotechnology, Health and Business in Canada, the United States and Worldwide

Tag Archives: First Amendment

A Third REMS Advantage? Allergan Says REMS for Botox Requires Off-Label Communication

Allergan sued the FDA earlier this month, claiming that the FDA’s prohibition of off-label promotion violates Allergan’s First Amendment rights by preventing Allergan from communicating about BOTOX’s REMS restrictions to physicians who need the information to properly treat off-label.  As the Allergan press release says:

“To serve the objectives of the FDA-mandated REMS program for BOTOX(R) and to assist physicians in evaluating the benefits and risks of the product, Allergan seeks a judgment that would permit it to provide currently available and truthful information to doctors for common off-label uses of BOTOX(R)”

I.e., the REMS forces Allergan to discuss the off-label uses.  Hrm.  The In Vivo Blog picks this one up and runs with it:

“the simple truth is that FDA now has the authority to do exactly what Allergan wants—allow, or indeed, require greater communication about off label uses. The suit focuses on the fact that FDA is not allowing as complete communication as Allergan wants—but the fact is that FDA could allow that under the existing law and in some sense “approve” an off-label promotion campaign.”

We’ll keep an eye out for the decision, but we don’t expect the District Court’s word to be final.  Meanwhile, having a product subjected to REMS “restrictions” is looking better and better.

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