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Preapproval Information Exchange With Payers: Guidelines Codified In Omnibus Spending Bill

 
• By Cathy Kelly

Legislation, known as PIE Act, does not force manufacturers to share information on pricing or economic models with payers but aligns with the requirements in US Food and Drug Administration guidance.

FDORA pie
Payers Hoping That Law Will Whet Manufacturers' Appetite For Sharing • Source: Shutterstock

Pharmaceutical manufacturers can feel more comfortable about proactively exchanging information with payers on drugs before they are approved now that legislation codifying the practice has passed in the US Congress.

Legislative provisions known as the Preapproval Information Exchange (PIE) Act was included in the 2023 omnibus government funding

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