Legislative Outlook: Compounding, Track and Trace, Animal Drug User Fee Could Carry Human Drug Proposals

ADUFA reauthorization may become the vehicle to move track and trace and compounding legislation. Reimbursement changes to mitigate shortages appear less likely.

Legislative Outlook: Animal Drug User Fee Could Carry Human Drug Proposals

Article preview from "The Pink Sheet"-  January 14, 2013

FDA policy watchers will not have a massive Prescription Drug User Fee Act to track in 2013, which may be good or bad news, but an “-UFA” bill again may steal the spotlight.

As 2012 ended, industry and FDA were digesting the implementation of the FDA Safety and Innovation Act.

Amid that massive task, the new Congress takes office with efforts to reach an agreement on drug shipment tracking standards and enhanced compounding regulations still pending. Additional enhancements to drug shortage mitigation efforts and antibiotic development also are lingering.

It appears the most likely vehicle for any agreements, should they be reached, is the animal drug user fee reauthorization, which must be renewed this year. It could serve as a must-pass bill for members of Congress to insert more FDA policy changes for human drugs.

Compounding and track and trace are both high-profile, but highly complicated, issues with fragmented stakeholder groups making proposals difficult to negotiate. However, the bipartisan interest in track and trace and compounding legislation makes both more likely to maintain their momentum.

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