Mandatory Mail, Thanks To FDA?
This article was originally published in RPM Report
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?
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Vivus’ second trip to an advisory panel was a much happier one, with the company’s weight loss therapy garnering an overwhelming “yes” vote on approvability. The key change? A Risk Evaluation & Mitigation Strategy that will be precedent setting if approved—and that demonstrates the power of REMS even if FDA moves in a different direction with this application.