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.
In a letter to the Food and Drug Administration (FDA), the CME Coalition applauds the agency’s recognition—as noted in its September 2014 report—that continuing medical education (CME) plays an essential role in improving knowledge of drug-related risks. The Coalition highlights their support for the FDA’s intention to evaluate the feasibility of drug-specific REMS CME training. As detailed in the letter, “preliminary research suggests that REMS-related CME can reach substantial numbers of providers who do not otherwise choose to engage with standard REMS communication, such as a Dear Healthcare Provider letter… As noted in the FDA’s September 2014 report, REMS CME activities could be developed both for approved drugs as well as for pending drugs prior to FDA approval, with the REMS CME published or presented upon drug launch.” The Coalition goes on to suggest that plans to develop CME should include provision of resources to measure and evaluate the effect of the activities, and expresses a willingness to work with the FDA regarding priorities for REMS education, resolution of priorities and barriers, and best practices for adult learning in the CME environment as it relates to REMS.
In a letter to Senate Aging Committee Chairman Herb Kohl and Sen. Bob Corker on the Sunshine Act, the CME Coalition also highlights the role of CME in FDA’s Risk Evaluation Management Strategies (REMS). The letter notes that "the central component of the Opioid REMS program is an education program for prescribers (e.g., physicians, nurse practitioners, physician assistants) and patients... Under the Sunshine Act rules as proposed, however, funds given to CME providers to produce REMS-mandated CME would constitute a transfer of value and would have to be reported. This could be a huge disincentive to participate in a REMS program because many physicians would not want to appear on lists for attending such programs. Moreover, the publication of payments made by manufacturers to CME providers who are providing the FDA mandated REMS would suggest impropriety and brings into question the objectivity of the program, despite the fact that FDA has mandated the specific educational components." The full comments are available below.
FDA Risk Evaluation and Mitigation Strategies (REMS) For Opioids Includes Prescriber Education Program
This post originally appeared as an article on the blog Policy & Medicine.
After three years of work the Food and Drug Administration (FDA) released its final Risk Evaluation and Mitigation Strategies (REMS) for extend-release (ER) and long-acting (LA) opioid medications. This is the first time that the FDA has mandated a class wide REMS and much of what is recommended will be looked at closely for future class REMS.
ER/LA opioids are highly potent drugs that are approved to treat moderate to severe persistent pain for serious and chronic conditions (list of ER/LA opioid products). The misuse and abuse of these drugs have resulted in a serious public health crisis of addiction, overdose, and death.