AMCP Applauds FDA for Final Guidance on Payer and Manufacturer Communications to Improve Patient Access to Emerging Therapies

Alexandria, Va., June 13, 2018 — The Academy of Managed Care Pharmacy (AMCP) commends the U.S. Food and Drug Administration (FDA) for issuing final guidance that clarifies how manufacturers can communicate truthful and non-misleading information with payers across a product’s lifecycle.

AMCP has been leading efforts to clarify and modernize payer and manufacturer communications, both in the pre-FDA approval and post-FDA approval space, to help address the rising cost of pharmaceuticals, enable the shift towards value-based payment models, and improve patient access to emerging therapies. AMCP is pleased that the final guidance largely aligns with these stakeholder recommendations and is also pleased that the final guidance has been expanded to include unapproved uses of approved or cleared products. AMCP CEO Susan A. Cantrell, RPh, CAE, issued the following statement on FDA action:

“FDA's action is an important step toward greater value for our pharmaceutical dollar and greater access for patients to emerging and breakthrough drug therapies. The FDA’s guidance also represents significant progress in the move toward adopting value-based health care models, which require payer access to better and timelier information during the decision making process.”

With the FDA guidance finalized, AMCP looks forward to working with Congress, the FDA, and stakeholders to advance H.R. 2026 – The Pharmaceutical Information Exchange (PIE) Act to provide additional clarity to manufacturers and payers regarding truthful and non-misleading communications pre-FDA approval.

The FDA’s final guidance, “Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities--Questions and Answers” is available at