Pre-approval Information Exchange (PIE)
The Pre-approval Information Exchange (PIE) Act of 2022 was signed into law in December 2022. First introduced in March 2022 by Representative Brett Guthrie as H.R. 7008 and subsequently included as Section 810 of the Food and Drug Amendments of 2022 (H.R. 7667), the PIE Act of 2022 is an important bipartisan bill that will enhance patient access to emerging pharmaceuticals and devices by authorizing pharmaceutical manufacturers to proactively share certain health care economic and scientific information about products with health payers ahead of Food and Drug Administration (FDA) approval. Although the FDA finalized guidance in 2018 regarding PIE, confusion remains around the circumstances under which manufacturers can provide information prior to approval and the nature of the information that can be provided. AMCP worked closely with Rep. Guthrie to ensure that the PIE Act will clarify the scope of PIE and resolve inconsistencies between the guidance and relevant statutory law.
The Pre-approval Information Exchange Act was passed by Congress on December 23, 2022, and signed into law on December 29 as part of the Consolidated Appropriations Act, 2023 (H.R. 2617).
Read AMCP CEO Susan A. Cantrell's latest blog in support of the PIE Act: PIE Act Gains Bipartisan Momentum Ahead of Year-End Push.
Please view the materials below for more information:
- Issue Brief
- Health Affairs Op-Ed
- PIE Process Flowchart
- Frequently Asked Questions
- E&C Health Leg. Hearing Letter of Support (3/17/22)
- E&C Markup Letter of Support (5/18/22)
- HELP Comment Letter on FDASLA (5/20/22)
- AMCP Statement on House Passage of HR 7667 (6/8/22)