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.
The Academy of Managed Care Pharmacy (AMCP) thanks the Food and Drug Administration (FDA) for the opportunity to provide comments in response to the draft guidance document titled “Labeling for Biosimilar Products: Guidance for Industry” published in the Federal Register on April 4, 2016.
AMCP is writing to express concern about proposals by the Food and Drug Administration (FDA) and a provision included in Section 11 of the “FDA and NIH Workforce Authorities Modernization Act” (S. 2700) that would exempt certain biological products, including biosimilars, from the requirement to adhere to U.S. Pharmacopeial (USP) public standards for quality, including the naming of biologic and biosimilar medicines.
On July 22, President Obama signed into law the Comprehensive Addiction and Recovery Act of 2016 (CARA). CARA creates a framework for opioid abuse prevention and treatment and authorizes $181 million in new spending to address the opioid epidemic. Bipartisan support and overwhelming vote margins (407–5 in the House and 92–2 in the Senate) are evidence that this issue was an important one. CARA aims to strengthen prevention, treatment, and recovery efforts, largely by empowering medical professionals and law enforcement officials with funding and tools.