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(AMCP) thanks the Food and Drug Administration (FDA) for the opportunity to provide comments in response to the draft guidance document titled “Labeling for Biosimilar Products: Guidance for Industry” published in the Federal Register on April 4, 2016.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.
AMCP supports a coalition of over 20 health care stakeholders committed to aligning 42 CFR Part 2 (Part 2) with HIPAA to allow appropriate access to patient information that is essential for providing whole-person care.
Partnership Forum: Industry experts gathered together July 19-20, 2016 to focus on innovations in diabetes care that are producing changes to treatment options, patient engagement, accountability and patient-provider interactions.