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Branded for Failure? Industry Hesitant to Adopt FDA Brand Name Review Pilot

This article was originally published in RPM Report

Executive Summary

FDA wants industry to endorse a pilot program that would make sponsors responsible for testing proposed brand names for medication errors. Industry is concerned the process will make reviews less predictable. But sponsors should ask themselves this: what's less predictable than the current 40% rejection rate?

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A Slow Takeoff for FDA's Brand Name Pilot Program

FDA's pilot program for testing and approving proposed brand names is slowly beginning to gain traction-despite initial concern from drug sponsors that the new process would lead to longer review times. For early adopters, it means a chance to collaborate with FDA on what will likely become the new regulatory standard. For everyone else, it may mean being a step behind.

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