Life Sciences Horizons Brochure 2025 - Flipbook - Page 114
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2025 Horizons Life Sciences and Health Care
The promise of RWD/RWE to continue to fine tune REMS
In the past few years, FDA has doubled-down on its
commitment to find ways to leverage real-world data
(RWD) / real-world evidence (RWE), which is data
collected outside of traditional clinical trials, such
as information from electronic health records,
patient registries, etc. This increased focus on and
appreciation of the benefits and insights from RWD/
RWE can and should be used to help enhance and
adapt Risk Evaluation and Mitigation Strategy
(REMS) programs.
In turn, these insights can lead to better sponsor and regulatory
decision-making. REMS programs often include elements such
as educational materials and clinical requirements that were
not necessarily included in clinical investigations for the drug.
RWD/RWE can help inform whether these elements are being
effectively implemented and whether they are achieving their
intended outcomes.
Although a REMS program is an essential tool for managing risks
associated with certain medications, they can be burdensome
and difficult to evaluate. Leveraging RWD can help create more
dynamic, responsive, and patient-centered strategies to monitor
and mitigate risks.
In fact, the application of RWD/RWE is uniquely suited to the
REMS context, because
the goal of a REMS program is to ensure that drugs are safe in
everyday clinical practice without impeding patient access or
unduly burdening the health care system, and
FDA requires sponsors to conduct periodic assessments of
REMS in the postmarket (“real world”) setting.
Improved risk monitoring with RWD can help arm sponsors with
insights on how a REMS is operating in clinical practice. RWD can
provide continuous, real-time monitoring of a drug’s safety profile
once it is in widespread use. This could enable the sponsor to
identify new risks promptly or demonstrate that expected risks are
not as frequent or severe as predicted or that known risks have
been effectively managed.
Lynn Mehler
Partner
Washington, D.C.
Eva Marie Schifini
Senior Associate
Los Angeles
