FDA REMS Open Public Meeting Explored Need for Flexibility in REMS Programs

The Food and Drug Administration (FDA) held a meeting on July 25th and 26th, 2013, to discuss Risk Evaluation and Mitigation Strategies (REMS). The FDA posted information about the meeting, including FDA slide presentation, agenda, and further reading.

We have covered this topic on many occasions. As part of the reauthorization of the Prescription Drug User Fee Act (PDUFA), FDA has committed to standardizing REMS to better integrate them into, and reduce their burden to, the existing and evolving health care system. As part of the PDUFA commitments, FDA will also seek to develop evidence-based methodologies for assessing the effectiveness of REMS.


A key delivery method for REMS programs has been through accredited CME. Murray Kopelow, M.D., President and CEO of the Accreditation Council for Continuing Medical Education (ACCME), delivered remarks at the meeting. Dr. Kopelow explained that the ACCME has a long-standing commitment to supporting public health priorities and described how accredited CME for prescribers supports the goals of FDA REMS.

Moving forward, Dr. Kopelow suggested that the FDA consider continuing to standardize the REMS process, but allowing more flexibility in content. He stated that the strength of CME lies in its expertise in producing educational activities targeted to physicians based on their professional practice gaps, individualized needs, and stages of learning and change. With more flexibility, accredited prescriber education related to REMS could go further in addressing individual prescribers’ educational and practice needs.

He also said that the effectiveness of REMS could also be measured in terms of how successfully it promotes access to education, mobilizes the education community to an issue, and draws the medical professions’ attention to a problem. Dr. Kopelow further emphasized that accredited prescriber education related to REMS will be independent of commercial influence and will meet the requirements of the ACCME Standards for Commercial Support.

“I was honored to have the opportunity to present at the FDA REMS meeting,” said Dr. Kopelow. “We appreciate that the FDA recognizes the value of accredited education. The ACCME has a long-standing commitment to supporting the role of accredited CME as a strategic partner in public health and safety initiatives. Certainly, accredited CME should be considered as a strategic asset to all those trying to improve drug safety.”


In addition, Ann Karty, M.D., medical director of the American Academy of Family Physicians’ (AAFS) Division of Continuing Medical Education, delivered a presentation on REMS requirements that pertain specifically to extended-release and long-acting (ER/LA) opioids. Karty stated the FDA needs to continue prescriber involvement when determining whether and how risks posed by certain classes of drugs and biologics will be mitigated. Because the REMS for ER/LA opioids is the first to involve a specific CME component, it “serves as a sort of case study,” she said.

According to Karty, if REMS-related CME was mandatory for prescribers, the overall continuing professional development of physicians, which includes a variety of information and procedural skill acquisition, could be diluted.

Karty explained: “I explained that REMS CME needs to be voluntary for prescribers, not mandatory,” Karty told AAFP News Now after the meeting. “(Physicians and other medical professionals) really need to keep patient outcomes in mind, and if the FDA is planning to include CME in their risk evaluation and mitigation strategies for products going forward, (the agency needs) to have a good reason for it.” She noted mandating CME to prescribe specific drugs could have an impact on patient access to those medications.

Asked in the question-and-answer session after her meeting presentation why she so strongly stressed the need for prescriber education to remain voluntary, Karty said mandatory CME has the potential to create a significant amount of confusion for physicians.

“Physicians, on average, have multiple licenses in multiple states, each of which may have different requirements,” she said. “So, for example, you have a physician who has two to four different licenses, many of which have different CME credit requirements that may or may not be reciprocal from state to state.

“You also have to consider those folks practicing in states that are already required to have topic-specific CME to maintain their license, as well as requirements for board certification,” Karty said. “On top of that, with the consideration by the FDA regarding recommendations for additional REMS-specific CME to be able to prescribe certain drugs, you can see how it gets confusing.”

“If you start adding more requirements, sooner or later, there is the potential that some people will not participate,” she said. “And then, for example, you’ll have a critical-access physician who isn’t able to meet the requirement and, suddenly, nobody in that region can prescribe a certain drug, thereby cutting off patient access.”

Karty said she thinks some form of prescriber education — whether formal CME or not — will continue to be a component of REMS going forward.

“As long as it continues to be an ongoing conversation, we are on the right track,” she said, referring to discussions with the FDA during public forum sessions. “In the meantime, family physicians need to participate in (REMS-specific CME) as it becomes available, because that will demonstrate to the FDA that we can self-regulate.”

“Participation is the current metric by which we are going to be judged by the FDA, so the continued recommendation is that physicians engage when presented the opportunity.”


Opening the FDA’s remarks was Theresa Toigo, Associate Director for Drug Safety Operations at the FDA’s Center for Drug Evaluation and Research (CDER). Toigo outlined a brief history of the REMS provisions in the Food and Drug Administration Amendments Act (FDAAA) of 2007, noting about 200 REMS have been approved since 2008. She stressed the agency is “listening to patients and health care providers” about REMS along with the pharmaceutical industry and FDA reviewers. The FDA continues to learn about REMS, and recognizes challenges facing the agency as: “the science and statutory framework for pharmaceutical risk management continues to evolve.”

Currently, the REMS Policy Workgroup, a component of the agency’s REMS Integration Initiative, is developing a draft guidance with several areas of focus in mind: (1) How to apply the statutory criteria to determine whether a REMS is necessary to ensure that the benefits of a drug outweigh the risks; (2) Describe considerations FDA takes into account in current benefit-risk assessments of drugs to maximize the Agency’s consistency in decision-making about the need for REMS; and (3) Provide information about when it may be appropriate to employ measures other than a REMS to address a serious risk. The FDA guidance and REMS Integration Initiative involves many parts and can be found here.

Adam Kroetsch, Operations Research Analyst in the FDA’s Office of Program and Strategic Analysis spoke about standardizing REMS, describing a three step process: (1) characterizing existing REMS; (2) identifying best practices, including getting feedback from internal and external stakeholders; and (3) ultimately creating standardized REMS. Gary Slatko, Director of the Office of Medication Error Prevention and Risk Management at the Center for Drug Evaluation and Research (CDER), described the FDA’s goal of a “science-based, healthcare intervention assessment framework for assessing REMS,” noting that the FDA will evaluate a new “proposed framework against prior programs”.

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