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Hahn Stresses Importance of Data, RWE in First All-Hands Meeting

Photo courtesy of FDA on Twitter.

Regulatory NewsRegulatory News
Posted 30 January 2020 | By Zachary Brennan 

Hahn Stresses Importance of Data, RWE in First All-Hands Meeting

3161 US Food and Drug Administration (FDA) Commissioner Stephen Hahn addressed FDA staffers in an all-hands meeting for the first time on Thursday, explaining how he wants to do more with real-world evidence (RWE), which has been a controversial subject.

While noting that FDA is operating in a time of “unsurpassed scientific and technological innovation,” Hahn called to unleash the power of data and “to attain more and better data,” according to a transcript of his speech. The comments build upon the agency’s technology modernization plan unveiled last September.

“By harnessing this power, we can improve our regulatory decision-making and more effectively connect today’s groundbreaking scientific discoveries with the rapid development and approval of new products. We can also increase the knowledge patients and consumers have to make informed decisions about FDA-regulated products,” he said.

Hahn also continued to push the agenda of his predecessor, Scott Gottlieb, who released an RWE framework in December 2018. Although the agency has only used RWE in limited amounts so far.

“Specifically, I believe there is great promise in the effective use and integration of patient-level data or real-world evidence such as electronic health records, clinical trials, medical studies, and patient registries,” Hahn said.

Former FDA Commissioners Robert Califf, Mark McClellan and Andrew von Eschenbach also offered their recommendations to expand the use of RWE in regulatory and payment decision-making. But questions on the applicability of RWE linger. A recent study in JAMA Open Network found that real-world data (RWD) could only be used to feasibly replicate 15% of high-profile clinical trials conducted in the US in 2017.

Califf, who now works as Alphabet’s new head of medical strategy and policy, also said RWE and RWD can include randomization and other methods to enable causal inference. "We worried at the time that the terms RWD & RWE would be hijacked to foster low quality research. This must be fought, because well done RWD & RWE with proper use of methods for causal inference is HIGHER quality & more generalizable," Califf wrote on Twitter.

Hahn also stressed the need to build upon FDA's Patient-Focused Drug Development initiative so “consumers may be even more informed and aware about the entire lifecycle of products we regulate in order to live more healthy and productive lives.”

And perhaps as a response to critiques of the agency’s recent speedy approvals of new drugs, Hahn said the agency needs to “maintain the vital balance between the speedy approval of new products and the integrity of the data and the process itself.”

Editor's Note: Article updated with comment from former FDA Commissioner Robert Califf.


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