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Time to Pay the Piper? Industry Prepares for a Fight Over User Fees

This article was originally published in RPM Report

Executive Summary

The pharmaceutical industry and FDA are getting ready for a fight-and for once they are on the same side. They want Congress to reauthorize the Prescription Drug User Fee Act quickly and cleanly-without tacking on other reforms to FDA's drug regulations. They probably won't get their wish.

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The Power of the Purse: FDA Seeks More Money, Not More Authority

Congress can't wait to shower FDA with more regulatory authority, especially in the area of drug safety. But unless Capitol Hill can puts its money where its mouth is, expanding FDA's mission will only send the agency deeper into a fiscal crisis -- and leave industry worse off as a result. An underfunded agency leaves officials scrambling to complete day-to-day activities -- and less time to on activities to further drug development, like nanotechnology and the Critical Path initiative.

The Power of the Purse: FDA Seeks More Money, Not More Authority

Congress can't wait to shower FDA with more regulatory authority, especially in the area of drug safety. But unless Capitol Hill can puts its money where its mouth is, expanding FDA's mission will only send the agency deeper into a fiscal crisis -- and leave industry worse off as a result. An underfunded agency leaves officials scrambling to complete day-to-day activities -- and less time to on activities to further drug development, like nanotechnology and the Critical Path initiative.

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