The Alliance for Regenerative Medicine (ARM) is the leading international advocacy organization championing the benefits of engineered cell therapies and genetic medicines for patients, healthcare systems, and society. As a community, ARM builds the future of medicine by convening the sector, facilitating influential exchanges on policies and practices, and advancing the narrative with data and analysis. We actively engage key stakeholders to enable the development of advanced therapies and to modernize healthcare systems so that patients benefit from durable, potentially curative treatments.
As the global voice of the sector, we represent more than 400 members across 25 countries, including emerging and established biotechnology companies, academic and medical research institutions, and patient organizations.
ARM recommends that Office of Inspector General adopt new safe harbors to permit certain arrangements that seek to overcome significant barriers to access for patients seeking cell and gene therapies.
The Alliance for Regenerative Medicine (“ARM”) appreciates the opportunity to respond to the solicitation by the National Institute of Standards and Technology (“NIST”) for comments on the Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights, which reviews the factors that an agency may consider when deciding whether to exercise march-in rights (the “Draft Framework”), about which we have serious concerns.
The Alliance for Regenerative Medicine (ARM) thanks Representatives McCaul, Eshoo, Bilirakis, Barragan, Trahan and Burgess for introducing H.R.7384: Creating Hope Reauthorization Act of 2024 which provides a timely and clean reauthorization of the Food and Drug Administration’s (FDA) Rare Pediatric Disease Priority Review Voucher (PRV) program.
ARM commends the Energy and Commerce Health Subcommittee for holding a hearing to discuss “Legislative Proposals to Support Patients with Rare Diseases”. We believe cell and gene therapies are critical in targeting the root causes of these diseases rather than treating symptoms and have the potential to transform the lives of afflicted patients.
The Alliance for Regenerative Medicine (ARM) urges CMS to take ARM Letter to CMCS Credentialing 030824 1steps now to facilitate credentialing by Medicaid providers across state lines.
ARM recently submitted a response to the House Committee on Education and the Workforce’s Request for Information on health plans operating under the Employee Retirement Income Security Act as they seek opportunities to build upon and strengthen the foundation of employer-sponsored health care.
Letter
ARM thanks Senator Cassidy for taking the lead on ensuring Americans have access to innovative and life-changing gene therapies and the opportunity to offer input on behalf of our diverse membership in response to his recent request for information.