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FDA Opens Up: Can Industry Live With Greater Transparency?

This article was originally published in RPM Report

Executive Summary

Drug sponsors are finding little to like about FDA's transparency initiative-especially proposals that would allow the agency to disclose more about products still in development. But given the public interest in greater transparency-and FDA's interest in avoiding another Avandia-industry needs to decide whether this is a fight worth having.

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A Painful Decision for King and Acura

An FDA advisory committee rejects the idea of adding niacin to abusable drugs in order to provoke a flushing reaction and thereby discourage abuse. King and Acura respond by flushing the idea itself and focusing on physical barriers to abusability. For other sponsors, King's failed attempt to change FDA's mind looks like a study in what not to do.

A Painful Decision for King and Acura

An FDA advisory committee rejects the idea of adding niacin to abusable drugs in order to provoke a flushing reaction and thereby discourage abuse. King and Acura respond by flushing the idea itself and focusing on physical barriers to abusability. For other sponsors, King's failed attempt to change FDA's mind looks like a study in what not to do.

Opening Up the Black Box: FDA Wants To Make "Complete Response" Letters Public

FDA's transparency initiative is starting to take shape. While many industry executives see the value in making more information available to the public, one idea makes them nervous: publicizing the letters FDA sends when it declines to approve a new drug or biologic. Top FDA officials already support making "complete response" letters public, and the Commissioner's office is open to the idea. How should industry prepare?

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