Posted by Michael Wonder on 13 Jun 2018
AMCP applauds FDA for final guidance on payer and manufacturer communications to improve patient access to emerging therapies
13 June 2018 - The Academy of Managed Care Pharmacy commends the U.S. FDA for issuing final guidance that clarifies how manufacturers can communicate truthful and non-misleading information with payers across a product’s lifecycle.
The Academy of Managed Care Pharmacy (AMCP) has been leading efforts to clarify and modernise 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.
