Unexpected, but welcome, inclusion in Cures 2.0 of provision for real-world evidence in evaluation of safety and efficacy of pharmaceutical products.

CONTEXT:  The follow-up to the U.S 21st Century Cures Act, already called Cures 2.0, broke cover this week as draft legislation was circulated for discussion.  Proposals within the bill are aimed at expanding research and development and streamlining regulatory processes to focus energy and resources into delivering new treatments to patients.  Key to the strategy will be the inclusion of real-world research, real-world data and a more pragmatic approach to assessing safety and efficacy of novel compounds, once the FDA has given the green light.  As written, the bill would amend post-approval study requirements for products granted accelerated approval to allow sponsors to submit other types of data to verify and describe a product’s benefit in addition to post-approval studies, including “clinical evidence, patient registries, or other sources of real world evidence.”

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1. “Less expected was a provision for the use of real-world evidence in evaluation of the safety and effectiveness of drugs and biologics after FDA approval, a provision that could prove useful in post-approval evaluations of products such as Biogen’s Aduhelm.” 

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3. “Cures 2.0 includes provisions for real-world evidence for drug postmarket study The follow-up to the U.S. 21st Century Cures Act, dubbed Cures 2.0, encodes several anticipated features such as a Medicare coverage mechanism for breakthrough devices and the Advanced Research Projects Agency for Health (ARPA-H).” 

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Source URL:https://www.raps.org/news-and-articles/news-articles/2021/6/cures-20-discussion-draft-signals-impact-on-fda-cr