As part of the Coalition’s ongoing monitoring and analysis of legislative opportunities related to CME, the Coalition has reviewed all relevant legislation that has been introduced in the 115th Congress and generated a new document outlining specific bills that prioritize the essential role of CME in improving health outcomes
Nearly 100 million people in the United States, or roughly one-third of the population, experience some form of chronic pain. Meanwhile, prescription opiate abuse and addiction have reached epidemic proportions in the United States, including the widespread illegal diversion of prescription opioids for street use, which in turn can increase the rates of abuse of illegal narcotics. Some clinicians have also prescribed opioids without adequate training surrounding their abuse potential. Many primary-care providers have recently become reluctant to prescribe opioid pain relievers in the context of current public health concerns surrounding addiction, which leads to some chronic pain patients now going without any appropriate treatment.
On May 3 and 4, 2017, the Food and Drug Administration (FDA) convened a public workshop (agenda) examining “Training Health Care Providers on Pain Management and Safe Use of Opioid Analgesics.” Andy Rosenberg presented testimony on behalf of the CME Coalition, in which he spoke to the role of CME in opioid prescriber education. Among the key points made in Andy’s remarks, "FDA should continue to rely on accredited CME as a vital tool in prescriber education in the opioid space. The strength of CME is that it can produce myriad educational activities that are targeted to physicians based on their professional practice gaps, individualized needs, and stages of learning and change. Added flexibility will allow prescriber education to better address individual prescribers’ educational and practice needs... Finally, as an incentive for prescribers to participate in opioid REMS, we recommend that the FDA encourage CMS to include opioid REMS as an improvement activity in the Quality Payment Program MIPS.”
On May 3-4, 2016, the Food and Drug Administration (FDA) hosted a two-day long Joint Meeting of the Drug Safety and Risk Management Advisory Committee (DSaRM) and the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) to discuss results from assessments of the extended-release and long-acting (ER/LA) Opioid Analgesics REMS. The CME Coalition submitted public comments following the meeting, emphasizing that FDA should consider standardizing the REMS process, while allowing more flexibility in content. The Coalition also suggested that REMS should be expanded to include short acting opioids.
On May 3-4, 2016, the Food and Drug Administration (FDA) hosted a two-day long Joint Meeting of the Drug Safety and Risk Management Advisory Committee (DSaRM) and the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) to discuss results from assessments of the extended-release and long-acting (ER/LA) Opioid Analgesics REMS. The FDA is seeking comments as to whether this REMS with Elements to Assure State Use (ETASU): actually assures safe use, does not unduly burden patient access to drugs, and somewhat minimizes the overall burden to the healthcare delivery system.