Expanded Cures 2.0 Legislation Considers Patient Access and Broadened Use of RWD in Clinical Trials

A recent article, published by the Regulatory Affairs Professionals Society (RAPS), notes that a discussion draft meant to further the goals of the 21^st Century Cures Act would bring several changes. In addition to considering how to streamline patient access to novel therapeutics, the legislation seeks to address the inherent challenges associated with real world data (RWD) in clinical trials. The draft also includes guidance that directly impacts the Food and Drug Administration (FDA).

“In addition to proposing new programs and enhancements for the US Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS), the 127-page draft bill would create the $6.5 billion Advanced Research Projects Agency for Health (ARPA-H) the Biden administration called for in its 2022 budget proposal. A concept paper outlining the White House’s vision for ARPA-H was published in Science alongside the release of the discussion draft.” Read more here.

(Source: Michael Mezher, RAPS, 6/23/21)