AMCP-Supported Bill to Create Safe Harbor for Pre-FDA-Approval Product Communications Is Examined in House Subcommittee on Health Hearing

Washington, D.C., July 12, 2017 — The U.S. House Energy and Commerce Committee’s Subcommittee on Health held a hearing today on the “Pharmaceutical Information Exchange (PIE) Act of 2017” (H.R. 2026). The bill, sponsored by Rep. Brett Guthrie (R-KY), would allow manufacturers to proactively share certain clinical and economic information with decision makers on emerging therapies in advance of Food and Drug Administration approval, an area currently restricted by federal law and FDA regulation.

AMCP last fall led a multi-stakeholder effort to develop recommendations on allowing pre-approval information exchange. H.R. 2026 closely aligns with these recommendations. AMCP CEO Susan A. Cantrell, RPh, CAE, issued the following statement on the hearing:

“The Academy of Managed Care Pharmacy strongly supports H.R. 2026 as it represents significant progress in the move toward value-based health care. We are delighted that the Energy & Commerce Subcommittee on Health is holding this important hearing today.

“As the health care system moves toward payments based on value, rather than volume, access to more and better information becomes crucial for health care decision makers.

“H.R. 2026 would enable the proactive dissemination of pre-FDA-approval information, with appropriate safeguards. This would allow health plans and other population health decision makers to more accurately forecast and prepare for emerging products. By allowing payers to make better coverage decisions sooner, patients can get access to breakthrough therapies sooner.”


Long-time AMCP member Katherine Wolf Khachatourian, PharmD, MBA, Vice President of Pharmacy Services, Strategy and Delegation Oversight at Qualchoice Health Plan Services, Inc., testified in support of H.R. 2026. Her comments included:

“The limitations on information we are able to obtain, results in a hindrance to patient access to novel and emerging therapies. It limits our ability to accurately forecast, plan and budget for anticipated expenditures, and it precludes our ability to contract on value rather than volume. This is the reason I am here before you today – to demonstrate the need for legislative framework, which will provide the key to unlock additional information needed for us to make more informed benefit decisions for better patient access to treatments.”

The Subcommittee on Health’s July 12 hearing was titled “Examining Medical Product Manufacturer Communications.” For more information on AMCP’s recommendations allowing pre-approval information exchange, read “Enabling the Exchange of Clinical and Economic Information Pre-FDA Approval.”