Since its establishment in 2021, the RWE Alliance has operated in service of four top-line priorities: (1) advancing and supporting FDA’s RWE Framework, (2) encouraging the use of RWE to better understand treatment effects in underrepresented populations; (3) enhancing opportunities for RWE organizations to consult with FDA; and (4) increasing communication on the generation and use of RWE. As the RWE Alliance looks ahead to its second anniversary, the coalition wanted to provide a recap of 2022 and highlight some key accomplishments.
The founding members of the RWE Alliance were Aetion, Flatiron Health, IQVIA, Syapse, and Tempus. In April 2022, the RWE Alliance doubled its membership, welcoming ConcertAI, OM1, Syneos Health, Verana Health, and Verily to its ranks. This effort has allowed the Alliance to expand its activities and take on new policy efforts. Additionally, new members bring more experts with different backgrounds to the table to formulate cohesive and detailed policy positions for the real-world data and analytics industry.
The RWE Alliance brought its expertise to bear on the suite of draft RWE guidance documents FDA released at the end of 2021 (available here). In detailed comment letters, the RWE Alliance provided FDA with insights from practitioners who work through these issues on a daily basis.
The RWE Alliance also engaged with key Capitol Hill offices on legislation relevant to RWD/E. The Alliance welcomed opportunities to provide offices with technical assistance and successfully advocated for changes in the accelerated approval provisions included in the end-of-year omnibus package—provisions originally considered as part of the FDA user fee reauthorization (the “UFAs”).
The RWE Alliance not only leveraged its industry expertise but also worked closely with biopharmaceutical industry stakeholders, as well as RWD/E think tanks, to inform our efforts. The group hosted regular meetings to seek input from company representatives on the Alliance’s policy development.
The RWE Alliance is proud of its efforts to advocate for policies that advance the use of RWE in regulatory decision making to benefit patients. The Alliance will continue to collaborate with an array of stakeholders to support broad efforts to advance the use of RWE. If you’d like to learn more about the RWE Alliance and how to get involved, please contact us at firstname.lastname@example.org.