American Academy of Pain Medicine Response to PROP Petition to the FDA That Seeks to Limit Pain Medications for Legitimate Noncancer Pain Sufferers

Abstract

There has been a concerted effort by public health, regulatory, and professional groups to curtail the serious problem of prescription opioid-related misuse that emerged during the last decade. The nature of this problem was fully explicated in a recent Pain Medicine Supplement [1], and the American Academy of Pain Medicine (AAPM) has been engaged with several agencies, including the United States Food and Drug Administration (FDA), the White House Office of National Drug Control Policy, and members of Congress to create long-term solutions focusing on professional education and research. On July 25, 2012 a petition with 37 co-signers was submitted to the FDA by Physicians for Responsible Opioid Prescribing (PROP), a group of concerned healthcare professionals and scientists, requesting label changes from the FDA in connection with certain opioid products as a means to address this public health crisis [2]. Members of the AAPM leadership reviewed this document, and after due deliberation and consideration of the petitioners' points viz-a-viz the AAPM mission, current scientific and clinical evidence, and ethical concerns for patient safety and health, the Academy responded to the petition with the following submission to the FDA signed by all members of the Board of Directors. This is now a public document, and we produce it here for the benefit of AAPM members, readership, and other interested parties. Bold headings have been added to assist the reader. No other content has been changed. You can reach your own conclusions and perhaps enrich the dialog with commentary, critique, concerns, and additional thoughts through correspondence to the Editor. The Academy looks forward to constructively working with members of PROP, Congress, and others to solve the serious prescription drug problem in America. The authors make the following disclosures of honoraria and consulting fees. During the past year, Dr. Fine has …