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Mandatory Mail, Thanks To FDA?

This article was originally published in RPM Report

Executive Summary

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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Setting the Stage: Qnexa and the Power of REMS

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.

Regulatory Alchemy: The Transformative Power of the Opioid REMS

The three-year long process towards a class-wide Risk Evaluation & Mitigation Strategy has been anything but straightforward. Still, the final twist may be the most surprising: FDA is now espousing the most industry-friendly approach on the table. The details of the opioid REMS will take months to work out and years to judge, but understanding the choices made in crafting this policy are a critical starting point.

REMS 2.0: FDA Refining New Drug Safety Tools

FDA’s new post-marketing risk management authorities are receiving much more public attention in the context of the Avandia decision…but use of the REMS is actually declining. As FDAAA turns 3, it is clear that REMS are going through some growing pains. The new tools will be refined—but they are definitely here to stay.

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