FDA Starts a New Limited Program for Advancing RWE
(Thursday, October 20, 2022)
Today FDA announced a new program for advancing Real World Evidence (RWE) aimed to develop new approaches for using RWE for labeling changes, new indications for previously approved drugs, or to support post-market commitments. The program will select a few sponsors who want to use RWE for the above purposes and use the experience and knowledge generated from interactions with them to write publications and guidance documents with suggested approaches for use of RWE for everyone. The entire program which will last till 2027 will select less than 10 sponsors over its life. The selected sponsor will get to discuss their RWE protocols with FDA prior to initiation. FDA reviewers will meet with the sponsor to brainstorm to help develop RWE protocols that meet regulatory requirements. In the process, FDA would gain experience and use that to generate policies and procedures for overall regulatory decision-making for RWE protocols and educate the rest of the stakeholders about acceptable RWE. To be selected the sponsor would need to have an active IND or pre-IND, intent to use RWE in the near future for new indications for previously approved products, or for post-market commitments, and be willing to allow FDA to publicly disclose the study designs originated during the sponsor-FDA interactions. The program seems very limited on its appearance but could lead to some good ideas about RWE. There has been a lot of interest in data mining medical records to generate RWE that is robust and acceptable to the FDA for meaningful applications. Despite publication of a few guidance documents and other publications, so far use of RWE for new approvals has been very limited. This new program may lead to some practical improvements, but it is hard to feel very optimistic about it based on the cryptic descriptions available from the FDA.
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Linkedin: Mukesh Kumar, PhD, RAC