FDA Announces New Device Guidance, Enhanced Patient Input Program

Ryan Black
JUNE 12, 2018


The FDA unleashed a pair of statements today that saw its Commissioner, Scott Gottlieb, MD, talk value-based care, emphasize enhanced patient engagement in drug development, and even name-checked phrases like  “big data.”

The central theme of both announcements (and the documents that accompany them) is communication: The first centers around the idea of improving communications between device or drug makers and payers, allowing them to more clearly evaluate the innovations before entering into value-based contracts.

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“The FDA believes it’s critical that information provided by manufacturers to payers about their medical products be truthful and non-misleading and that appropriate background and contextual information be provided to enable payers to make informed decisions,” Gottlieb wrote.

The 2 new guidances give specific directions on how healthcare economic information should be expressed and transmitted: 1 involves manufacturer-payer communications, the other regards labeling. The latter is meant to clarify what constitutes “FDA-required labeling” in order to better inform patient care and, again, the forging of value-based contracts.

The second announcement came just hours later. It trumpets a new draft guidance for patient input on drug development—particularly as it pertains to new and novel therapies.

“We learn through scientific advances, but also by listening to patients,” Gottlieb wrote. “Our work demands that we must continue to reflect on how we can make the science of drug development and review more modern and more patient-centered, so that approved products impact the metrics that real-world patients and families value most.”

Drug development is changing quickly, the announcement acknowledges, since therapies can be even more specifically-targeted and made for smaller and smaller populations (the genetic element of this trend does not emerge in the text, but it may be a subtext). The announcement does allude to the Breakthrough Therapy designation, through which potentially game-changing developments like CAR-T cell therapy have gained a foothold.

The idea behind the new guidance is that, by gaining a better understanding of what patients go through with certain conditions, the FDA can better shape its benefit-risk assessments. The agency said it had already conducted more than 20 listening sessions with patients suffering a host of chronic conditions. The new guidance specifically pertains to patient data collection, and is to be the first of four on the subject.

And, as always, the announcements were accompanied by tweets. The Commissioner is prolifically active on the social media platform, and today was no exception. He framed the guidances as part of an overarching effort, before moving on to retweet a series of press reports about them:
 
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