The undersigned pharmacist organizations thank the Food and Drug Administration (FDA) for the opportunity to provide comments on the reauthorization of the Prescription Drug User Fee Act (PDUFA) for fiscal years (FY) 2018 through 2022 as published in the Federal Register on July 19, 2016. Collectively, our organizations represent over 100,000 pharmacists across the full spectrum of health care practice settings.
The Academy of Managed Care Pharmacy (AMCP) opposes House Bill 976. This bill would amend Chapter 112 Section 12EE (a) by replacing the words “biosimilar and interchangeable” in the definition of “interchangeable biologic product” with the words “therapeutically equivalent to”. This new proposed definition is inconsistent with existing Massachusetts law, which follows the language in the Biologics and Price Competition and Innovation Act (BPCIA).
The Academy of Managed Care Pharmacy (AMCP) supports the passage of House Bill 2041. This legislation would recognize pharmacists as health care providers and authorize them to perform certain patient services including drug therapy management and administering drugs and biological products to a patient pursuant to a physician’s orders. As health care delivery in the United States continues to evolve and the focus increases on an interdisciplinary team approach to patient care, it critical to achieve better quality patient care that pharmacists are recognized as health care providers.
Press Release: Variations in how biosimilar products are named may affect the willingness of some pharmacists to substitute an interchangeable biologic for its branded reference product, according to a survey study published in this month’s Journal of Managed Care & Specialty Pharmacy (JMCP).
The Academy of Managed Care Pharmacy (AMCP) recognizes the value of medication synchronization as one tool that may improve adherence. However, we urge you to oppose Assembly Bill 2050 because it would mandate synchronization of medications without the benefit of industry input and a study of existing programs.
AMPC CEO Blog: “Healing is a matter of time, but it is sometimes also a matter of opportunity,” said the great Hippocrates, father of western medicine.