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'Safe Harbor' For Preapproval Information Exchange To Get Legislative Push

 
• By Sue Sutter

US Academy of Managed Care Pharmacy is developing language to protect exchange of clinical and economic information on pipeline products between manufacturers and healthcare decision-makers; safe harbor could find a home in legislation reauthorizing FDA user fee programs.

Language creating a "safe harbor" for drug manufacturers to proactively share clinical and economic information with payers and other healthcare decision-makers ahead of product approval could find its way into FDA user fee legislation that must pass Congress in 2017.

The Academy of Managed Care Pharmacy (AMCP) is leading a multi-stakeholder push for legislation to protect preapproval information exchange (PIE) between manufacturers and entities responsible for making population health decisions,...

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