Groups Seek Congressional Action on Drug Shortages - 03/23/2012 - The Burrill Report

Groups Seek Congressional Action on Drug Shortages - 03/23/2012 - The Burrill Report

PUBLIC HEALTH

Groups Seek Congressional Action on Drug Shortages

Discounted generic drug application fees proposed as incentive to curb shortfalls.

MICHAEL FITZHUGH

The Burrill Report

“We believe appropriate mechanisms, such as a generic user fee program, could provide a crucial economic tool for FDA to provide incentives to manufacturers, and should be enacted as quickly as possible”

A group of more than 30 organizations seeking to address drug shortages in the United States has written a letter urging Congressional action to solve the problem.

The letter, sent to Senator Tom Harkin, D-Iowa, by groups representing clinicians, healthcare facilities, drug manufacturers, and patient advocates, urges Congress to consider implementing a generic user fee program in the upcoming Prescription Drug User Fee Act reauthorization, or PDUFA.

 The fees could be used to allow the U.S. Food and Drug Administration to “offer reduced application fees for products in short supply, or discounted fees if a company demonstrates that its contingency plans are sufficient to reduce the risk of a shortage if production is halted,” they suggest.

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Groups Seek Congressional Action on Drug Shortages - 03/23/2012 - The Burrill Report