By Marie-Claire Wilson and Sherry Mills
We ran a roundtable at the WDSC Americas in October 2023, asking participants to identify the “sweet spots” in the aRMM/REMS development process that could offer opportunities for harmonisation, as well as points at which MAHs were likely to encounter barriers in aligning the two approaches. We used European and US versions of well-known chocolate bars to illustrate the concept of aRMM and REMS having different wrappers and some different ingredients, but with their overall purpose (sweet treat/protecting patients) nevertheless being the same.
Participants identified the implementation stage of the RM development process as being the stage where harmonisation could be most likely, but also the stage where barriers are most evident. These barriers are presented by the differing regulatory frameworks in the US and Europe.
One way to address these barriers is to focus on operational harmonization, rather than regulatory harmonization. This means putting the patient at the centre and developing programs to mitigate key risks associated with a group of products, regardless of the product, manufacturer, or geography.
Another opportunity for harmonization is in the use of data and analytics. By setting common metrics across all risk management programmes for a particular product, and sharing the resulting data, manufacturers can gain a more holistic view of product risks and develop more effective mitigation strategies.
Data collection is a hot topic in drug safety – GVP XVI Revision 3, which provides guidance on the measurement of risk management effectiveness is due for finalisation in 2024 by the European Medicines Agency (EMA). The guidance highlights the importance of using data and analytics to measure the reach of risk mitigation measures, their implementation fidelity, and the impact on patient outcomes. A variety of data sources could be used to measure effectiveness, including healthcare claims data, patient surveys and adverse drug reaction reports, as well as real world data. Perhaps the new version of this piece of regulatory guidance will encourage MAHs to examine possibilities for aRMM and REMS harmonisation more closely.
aRMM and REMS can appear to be an ocean apart, due to the distinct regulatory frameworks in the US and Europe, but there may be ways to bring about elements of operational harmonisation. Maintaining a focus on the patient, taking a risk-based approach, and considering how data collection could be a force for standardisation are all possibilities. We’d be keen to hear from any aRMM or REMS professionals that would like to further these discussions through a working group.
EMA Guideline on Risk Management Plans for Medicinal Products (2012)
FDA Guidance for Industry: Risk Evaluation and Mitigation Strategies (REMS) (2012)
Pharmaceutical Research and Manufacturers of America (PhRMA) Position Paper: Harmonizing Risk
Management Programs for Pharmaceutical Products (2015)
European Medicines Agency (EMA) Workshop Report: Harmonizing Risk Management Programs for Pharmaceutical Products (2016)
Food and Drug Administration (FDA) Workshop Report: Harmonizing Risk Management Programs for Pharmaceutical Products (2017)