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FDA Statement

Statement by FDA Commissioner Scott Gottlieb, M.D. on new steps by FDA to advance patient engagement in the agency’s regulatory work

For Immediate Release:
Statement From:

The Food and Drug Administration is hosting a pioneering event today: the first meeting of the Patient Engagement Advisory Committee or PEAC. It’s a significant step forward in the FDA’s efforts to broaden its engagement with patients – and to deepen the involvement of patients in our regulatory activities.

This is the agency’s first advisory committee that’s comprised solely of patients, care-partners, and those who represent their needs. Founded by the FDA’s Center for Devices and Radiological Health (CDRH), it reflects CDRH’s commitment to keep patients at the center of their work.

The FDA’s work requires us to establish objective, consistent criteria on which we base our decisions. But ultimately, the criteria we use to judge benefit and risk turn on the parameters that matter to patients.

Involving the end-user – the patient – in identifying health priorities and outcomes desired from health interventions is critically important.

This requires cultures and processes that ensure routine integration of these patient perspectives at each key stage of product development.

CDRH is working with a diverse group of outside partners to encourage the inclusion of patient perspectives across the total medical device life cycle, from the design and ideation of the medical device to the clinical trial process and through the postmarket evaluation. This includes new guidance on patient preference information for premarket approvals (PMAs), Humanitarian Device Exemption (HDE) applications, de novo requests, and for inclusion in device labeling. This guidance describes how patient tolerance for risk and perspective on benefit can be considered as part of the FDA’s assessment of the benefit-risk of certain devices.

Today’s meeting is focused on engaging patients in the clinical trial process from design to recruitment to enrollment and retention in clinical trials, and how we communicate about clinical trial results.

CDRH has worked to advance the development of patient preference studies and patient-reported outcome measures in a wide range of device areas ranging from prosthetic limbs to minimally invasive surgical devices designed to treat the eye condition of glaucoma.

CDRH has also led the charge to integrate real world evidence into our regulatory decision making process, with issuance of the real world evidence guidance two months ago. This guidance encourages stakeholders to leverage information contained in electronic health records, insurance claims databases, and registries to facilitate more efficient regulatory decisions for medical devices.

Patients are increasingly collecting much of this real world data. Patients are spearheading the creation of novel registry platforms that collect health data to track their progress, and facilitate medical product evaluations. We’re fostering interactions with these patient-led registries to help them become vehicles for regulatory change.

Rapid advances in smartphones enable the creation of platforms that make it easier for patients to take ownership of their health information. It also allows us to use more of that information to advance regulatory decision-making and product science. This is especially relevant as more information is being collected in real-world settings, and more closely reflects the patient experience. This gives us a new and valuable perspective on the performance of technologies.

The bottom line is this: When assessing whether valid scientific evidence shows that a device’s probable benefit outweighs its likely risks, the FDA can also consider rigorous, systematically gathered patient preference information as a part of the totality of the evidence from clinical and nonclinical testing. One of the mandates of this committee will be to help us develop the parameters for assessing these questions. When does this preference information meet the right standard, and address the right criteria, to be relevant to inform our decisions?

The FDA will take additional agency-wide steps in the coming months to build on these and other efforts. One of those is the creation of a new team that will be responsible for the coordination of certain agency-wide and multi-center projects related to patient engagement.

The goals of this new patient affairs team are to better leverage and expand the relationships that our medical product centers already have directly with patient organizations. Not to replace these engagements.

This is not about creating a single front door, or a new door, for patient organizations to interface with the FDA. Groups that already have relationships directly to our medical product centers will maintain those engagements. Our preference is for patient groups to interface directly with the review programs. For groups that don’t know how to access the FDA, this new function can serve as an initial entry point.

But the broader goal is to facilitate cross-center policy making when it comes to how we develop more consistent and cutting edge approaches to engaging patient perspective into our scientific process. We need to elevate the science of these endeavors, and develop some basic, common practices and principles. As the science of measuring patient preferences continues to evolve, our policies must also adapt.

Our aim is to facilitate the development and use of patient-focused methods in more parts of our regulatory activities as well as develop and elevate common standards for how to integrate the patient voice, as a matter of science, into product development.

Among some of the long-term goals of these new efforts is the creation of consistent approaches to how the FDA develops clinical outcomes assessment tools such as patient-reported outcomes to inform our regulatory decisions. Another goal is to maintain robust data management systems to incorporate and formalize knowledge sharing with the agency by patient stakeholders and patient communities.

This new patient affairs team is one reflection of our commitment to the goal of elevating the patient role in our work. The advisory committee that we’re inaugurating today is another measure of that promise.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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