FDA Turns to CME for Risk Evaluation and Mitigation Strategy (REMS) Pain Education

According to a FDA memo and recent article in the RPM Report, “continuing medical education (CME) has been under attack in Washington in recent years, criticized as representing a way around FDA’s control of medical promotion.” This trend however, is beginning to change.

The Food and Drug Administration’s (FDA) is now “turning back to CME as the keystone to controlling a tough drug overuse/abuse situation.” Specifically, FDA’s “proposed class-wide REMS (risk evaluation and mitigation strategy) for long-acting opioid pain products will rely on physician education with materials pre-approved by FDA as the key post-marketing control tool.”

FDA’s proposal “is the product of a broad year-and-a-half-long effort by the agency that entailed the work of 70 staff members broken up into eight working groups.” Consequently, this FDA team also held three meetings over five days for stakeholders and a two-day offsite retreat.”

In considering proposals, FDA decided that REMS should not include a physician registration and verification system at the point of dispensing to make sure that physicians are not over-prescribing long-acting opioids, according to a June 22 memo from FDA Division of Anesthetics & Analgesia Products Director Bob Rappaport, MD, which was sent to the members of two agency advisory committees.

In addition, Dr. Rappaport’s June 22 memo represents the agency’s statement of its proposal for the REMS, in which FDA will be convening a joint meeting of the Anesthetic & Life Support Drugs Advisory Committee and the Drug Safety & Risk Management Advisory committee on July 22-23 to advise the agency on its proposed class-wide REMS for long-acting opioids. Rappaport’s.

Although FDA has already “put together a thorough analysis of options and public comments as a foundation for the advisory committee discussion,” it’s possible that “the joint advisory committees could review FDA’s proposal and recommend a different set of control mechanisms.”

To determine the proper balance for education requirements in the REMS proposal, the RPM report noted that “FDA is going to try to walk a fine line on the education requirement: stopping short of demanding proof of education of each prescriber but attempting to show that educational efforts have been undertaken seriously and have a positive effect on physician knowledge.”

This means that FDA will be looking to CME for educator independence, and that the agency will be reviewing training materials for pre-approval as key “features to a successful opioid REMS program.” Part of this process would include a curriculum developed by an “expert panel, including representatives from specialty boards, medical societies, academia, FDA, and other relevant government agencies.” This would create “the broadest perspective and assembly of expertise and would be acceptable to the majority of stakeholders,” although it is unclear who would pay for the panel’s time and expertise.”

To ensure this kind of independence, Dr. Rappaport noted in his memo that FDA “would encourage sponsors to develop the prescriber training in partnership with an appropriate, independent third party, and FDA would approve the training content.”

Such encouragement recognizes the value of CME providers and funding for CME from all sources, especially since providers “appear well-positioned for the opioid effort as intermediaries which can assure FDA of the independence of training (distanced from the marketer) and as a way to entice physicians to participate.” Making the collaboration of CME providers and opioid REMS programs even more promising is that fact that FDA is encouraging sponsors to also “explore appropriate incentives (e.g., CME credit) to encourage prescribers to undertake the training.” In doing so, FDA has clearly acknowledged the crucial role third party providers can play in the education of physicians and health care providers through CME.

Moreover, FDA explicitly acknowledged that “the agency does not want to establish a program at this point to test prescribers on their knowledge of opioids and selecting appropriate patients and dosing/dispensing quantities for opioid use.” Although the agency suggested FDA programs should be tied to Drug Enforcement Administration registration, that idea would take new legislative authority that FDA “will not push for at this point.”

“Instead, FDA is going to throw that burden back on the drug marketers, who will be required through surveys and evaluation to show that their programs are having a positive effect on prescriber knowledge of opioid use.”

But a problem with FDA’s proposal is that the agency did not ask sponsors “specifically for data from tracking systems to show that opioid misuse has declined due to the REMS training effort.” In fact, as the RPM notes, “there is mention in one of the descriptions of the metrics that FDA expects during the evaluation part of the REMS that implies that sponsors will be responsible for data beyond physician understanding.”

What FDA did say is that “it will conduct separate observations of opioid use data to see how well the education-based REMS works – i.e. how effectively it reduces inappropriate use.” Additionally, FDA noted that it has “initiated collaborations with a number of its Federal partners to develop metrics to monitor changes in prescribing behavior, non-medical use of opioids, and certain adverse outcomes (overdose, addiction, and death).”

FDA also did not ask sponsors for a “demonstration of the effect of the program on physician knowledge,” such as asking sponsors for information on “certain behaviors (such as nonmedical use of prescription opioids), adverse events (unintentional overdose, addiction, and deaths related to prescription opioids), and access to care.”

Accordingly, RPM recommended that these lapses could and should be discussed at the advisory committee meetings on July 22-23. The article also noted that the meetings should discuss “the limitation of the REMS to long-acting and extended-release opioids,” since the agency overruled the working group’s recommendation for this.

FDA also addressed it will not “require a patient registry because with four million patients taking long-acting opioids, it will burden the system.” The agency instead, will work with medical societies and other groups to encourage the use of “pain treatment agreements” between patients and prescribers.

Consequently, despite FDA’s acknowledgement that CME providers and third parties will be responsible for education physicians, the nine-member working group, headed by Division of Risk Management Deputy Director Mary Willy, noted that it “considered concerns about the current CME/CE system’s ability to effectively teach” content that would improve health outcomes with opioids.

These concerns were resolved however as “the FDA group noted that recent rigorous examinations of CME have created “a proposed framework for improving the effectiveness of CME/CE, both at the macro-and micro-level.” This framework acknowledged that although “an industry working group would have “the resources and a vested interest in the subject,” potential conflicts of interest made such a recommendation difficult. With content being controlled explicitly by providers, and not industry, the potential for conflicts can be effectively managed without sacrificing industry support of CME programs for REMS opioid programs.

Ultimately, the FDA has recognized that relying on third party providers is essential to educate physicians through CME regarding opioid programs. Since FDA currently does not have the necessary resources itself to develop the content of such programs, it is clear that FDA will want to work with providers who use industry resources to develop CME that will help solve opioid use problems.  



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