Sep 10, 2015 - On behalf of patients, providers and manufacturers, we are writing today to strongly recommend against in
September 10, 2015 The Honorable Sylvia Mathews Burwell Secretary Department of Health and Human Services 200 Independence Avenue, SW Washington, D.C. 20201
Howard Shelanski, Administrator Office of Information and Regulatory Affairs Office of Management and Budget 725 17th Street, NW Washington, D.C. 20503
Dear Secretary Burwell and Administrator Shelanski: On behalf of patients, providers and manufacturers, we are writing today to strongly recommend against including medications with abuse-deterrent formulations (ADF) in the line extension definition proposed in the February 2012 Centers for Medicare & Medicaid Services (CMS) proposed rule entitled Medicaid Program; Covered Outpatient Drugs (CMS-2345-F). It is our understanding that the proposed Final Rule is currently under review by the Office of Management and Budget (OMB). Without modifications to the proposed rule, manufacturers of ADF products would be subject to additional rebate obligations under the Medicaid program, which would serve as a major disincentive to developing ADF products. We appreciate that patient access to pain medication must be balanced with the risk of prescription drug abuse, which is a serious public health crisis in too many communities across this nation. Indeed, opioid analgesics have been implicated in soaring rates of drug overdose deaths over the last decade. In response, a number of national and federal initiatives are tackling this challenge head-on, most recently the July announcement by the Department of Health and Human Services (HHS) of a new opioid initiative focused on opioid prescribing practices, expanded use of naloxone and expanded use of Medication-Assisted Treatment. We enthusiastically support HHS’ initiative and many of us will be active participants in its implementation. However, we must not lose sight of the fact that these drugs are critical for modern pain management, especially for patients with cancer and other serious conditions. As such, we have supported long-standing efforts by the Food and Drug Administration (FDA) and industry to develop newer formulations of opioid analgesics that may deter abuse and misuse. As one tangible outcome of this effort, in April 2015, the FDA finalized the “Abuse-Deterrent Opioids — Evaluation and Labeling Guidance for Industry.” This guidance clarified the rigorous development pathway for ADF products, which requires a significant investment of time and resources by manufacturers. A number of agencies within HHS, including the National Institute of Drug Abuse at the National Institutes of Health and the Substance Abuse and Mental Health Services Administration, as well as the Office of National Drug Control Policy at the White House, are very supportive of ADF science and drug development. In contrast, CMS’ proposed line extension policy is not supportive and would seriously threaten industry incentive to create ADF products. Further, the CMS policy does not reflect the significant advances in the underlying science nor the development of robust regulatory frameworks, which have been underway for nearly a decade. Many stakeholders have expressed
Center for Lawful Access and Abuse Deterrence 1000 Potomac St., NW, Suite 150-A · Washington, DC 20007 · 202-599-8435 · www.claad.org · @claad_coalition
concern with CMS’ Proposed Rule, including senior members of Congress who have sent letters to HHS leadership stating this policy runs afoul of Congressional intent. Again, we strongly request that medications with abuse-deterrent formulations (ADF) not be included in the line extension definition for outpatient drugs in CMS’ Final Rule. We would like to discuss with you this matter in more detail as soon as possible, and will be in contact to request a meeting to this end. Sincerely, Center for Lawful Access and Abuse Deterrence American Academy of Pain Management American Society for Pain Management Nursing Atlantic Pharma Chronic Pain Research Group, University at Buffalo School of Pharmacy and Pharmaceutical Sciences Collegium Pharmaceuticals Community Anti-Drug Coalitions of America (CADCA) Egalet Corporation Elysium Therapeutics Endo Pharmaceuticals Gatekeeper Innovation, Inc. Grünenthal USA, Inc. Healthcare Distribution Management Association Inspirion Delivery Technologies Interstitial Cystitis Association Johnson & Johnson Kem Pharm National Fibromyalgia & Chronic Pain Association National Hospice and Palliative Care Organization Pain Connection-Chronic Pain Outreach Center, Inc. Partnership for Drug-Free Kids Pernix Therapeutics Project Lazarus Purdue Pharmaceuticals Reflex Sympathetic Dystrophy Syndrome Association Teva Pharmaceuticals The Pain Community Wisconsin Pain Initiative U. S. Pain Foundation
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