The Academy of Managed Care Pharmacy (AMCP) is pleased provide comments to the Centers for Medicare & Medicaid Services (CMS) in response to the proposed rule “Medicare and Medicaid Programs; Regulation to Require Drug Pricing Transparency [CMS-4187-P]” published in the Federal Register on October 18, 2018.
On Dec 12, 2018, FDA issued a new proposal to amend its regulation that defines “biological product” to incorporate changes made by the Biologics Price Competition Act of 2009 (BPCI Act). The BPCI Act amended the definition of biological product to include a “protein (except any chemically synthesized polypeptide.” To clarify these terms, FDA is proposing to provide its interpretation of the terms “protein” and “chemically synthesized polypeptide" to reduce regulatory uncertainty over what products are regulated as drugs or biological products.