Letters, Statements & Analysis
AMCP communicates the importance of managed care pharmacy by collaborating with members to provide comments, analysis, and testimony to Congress and federal and state agencies on the impact of proposed regulations and laws on managed care pharmacy and patients.
As stakeholders that support patient access to affordable medicines and competition in the pharmaceutical marketplace, we applaud the Food and Drug Administration’s (FDA) efforts to foster the development of biosimilar medicines for America’s patients.
The Academy of Managed Care Pharmacy (AMCP) thanks the Food and Drug Administration (FDA) for the opportunity to provide comments in response to the updated draft industry guidance on “Nonproprietary Naming of Biological Products” published in the Federal Register on March 8, 2019. AMCP appreciates FDA’s ongoing efforts to issue and update guidance that allow health care providers to safely and effectively use biosimilar products.
The Academy of Managed Care Pharmacy (AMCP) thanks the Department of Health and Human Services Office of Inspector General (HHS-OIG) for the opportunity to provide comments in response to the proposed rule titled “Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of a New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees [OIG-0936-P]” published in the Federal Register on February 6, 2019.
AMCP writes to request your veto on House Bill 435 which implements an exception process for coverage of a drug removed from a formulary at the previous cost sharing level. Imposing government mandated restrictions on formularies as outlined in the bill could have the unintended consequence of raising the overall cost of health care coverage for patients.
AMCP shares concern about the rising costs of medications and the impact on patients, payers, and providers. In 2017, AMCP identified three key areas where AMCP members help to improve health outcomes and lower costs. These areas focus on enhancing value for outcomes; enhanced approaches to medication coverage determinations; and market competition for generics and biosimilars to lower costs.
AMCP expresses our strong support for H.R. 965, the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act, bipartisan legislation to increase competition and patient access to safe and affordable generic and biosimilar medicines. AMCP is pleased with the reintroduction of the legislation into the 116th Congress on February 5, 2019.
AMCP shares the committee’s concerns about the unsustainable burden of high drug pricing on patients and providers and has been working with stakeholders to educate Congress on ways that AMCP pharmacists, physicians, and nurses can improve health outcomes while lowering costs.
On Dec 12, 2018 The Food and Drug Administration (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).
