1. Pink Sheet

Mandatory Mail, Thanks To FDA?

 
• By Michael McCaughan

Vivus’ weight loss drug Qnexa cleared committee thanks in large part to a REMS proposal that FDA hopes is less burdensome than a traditional pregnancy prevention program. But will the agency really end up mandating a mail-order-only drug distribution network for a mass-market product?

In December, New York governor Andrew Cuomo signed into law a provision prohibiting insurers and employers from implementing mandatory mail order provisions in the state—the most important victory to date in the seemingly never-ending battle between community pharmacy and large pharmacy benefit management/mail-service companies.

At the same time, Vivus Inc. was working on a novel risk management program for its weight loss drug Qnexa (phentermine/topiramate) which just might turn into an unprecedented FDA-mandated...

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