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(AMCP) thanks the Food and Drug Administration (FDA) for the opportunity to provide comments in response to the draft guidance document titled “Labeling for Biosimilar Products: Guidance for Industry” published in the Federal Register on April 4, 2016.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.
The Academy of Managed Care Pharmacy (AMCP) supports the passage of Assembly Bill 3982 mandating that practitioners issue prescriptions for controlled substances electronically using an electronic health records system. E-prescribing for controlled substances would reduce some prescription errors and help prevent more than 2 million adverse drug events per year, 130,000 of which are life threatening. AMCP members seek to reduce the public health crises associated with medication prescribing errors, abuse and diversion of opioids, all of which AB 3982 addresses.
Press Release: The Academy of Managed Care Pharmacy (AMCP) commends the Senate for its overwhelming 92-to-2 passage of S. 524, the Comprehensive Addiction and Recovery Act (CARA).
AMCP CEO Blog: It was only ten years ago when biosimilars were so new that the New York Times described them as “so-called.” As late as five years ago newspapers put quotation marks around the term, as in “biosimilars.”
The Department of Health and Human Services (HHS) and the Substance Abuse and Mental Health Services Administration (SAMHSA) released a final rule titled “Medication Assisted Treatment for Opioid Use Disorders” scheduled to be published in the Federal Register on July 8, 2016. AMCP had submitted comments on the draft rule urging for provisions related to team-based care, education on diversion mitigation strategies, and the expansion of practitioner eligibility to prescribe buprenorphine for opioid abuse disorders.
The Academy of Managed Care Pharmacy (AMCP) appreciates the opportunity to submit comments for the record on the hearing titled “Examining the Proposed Medicare Part B Drug Demonstration” held on June 28, 2016. AMCP submitted detailed comments1 to the Centers for Medicare and Medicaid Services (CMS) in response to the proposed rule titled “Medicare Program; Part B Drug Payment Model (CMS-1670-P)” published in the Federal Register on March 11, 2016.