The US agency says in a 6 January Federal Register notice that it’s keeping its Patient Engagement Advisory Committee in place through October 2021 so it can gather more patient feedback that will come in handy when regulatory decisions need to be made. The committee, formed after the agency made a cultural shift to consider patient input on the types of products it allows on the market, was supposed to expire October 2019.
The US Food and Drug Administration is keeping in place its Patient Engagement Advisory Committee (PEAC) so it can continue gaining valuable patient feedback on certain regulatory decisions. The committee was formed after the agency made a cultural shift to consider patient input on the types of products it allows on the market.
The PEAC was originally slated to disband on in October 2019, but the FDA says in a 6 January Federal Register notice that the committee will remain through October 2021.
The committee offers advice on device regulation from the patient perspective, including topics such as FDA guidance documents and policies, clinical trial or registry design, patient preference study design, benefit-risk determinations, device labeling, unmet clinical needs, available alternatives, patient-reported outcomes, and device-related quality-of-life or health status.
“The committee provides relevant skills and perspectives to improve communication of benefits, risks and clinical outcomes, and increase integration of patient perspectives into the regulatory process for medical devices,” the FDA said in a statement. “It performs its duties by identifying new approaches, promoting innovation, recognizing unforeseen risks or barriers and identifying unintended consequences that could result from FDA policy.”
The PEAC’s core is made up of an expert panel of nine voting members with knowledge in areas such as clinical research, primary-care patient experience and the health-care needs of patient groups. Panel experts also may have experience in the work of patient and health professional organizations, methodologies for eliciting patient preferences, and strategies for communicating benefits, risks and clinical outcomes to patients and research subjects.
The committee has held a number of important gatherings since its inception, including a October 2017 meeting on patient preferences in clinical trials, a November 2018 meeting on the use of patient experience on social media, and a September 2019 meeting on how the FDA can communicate medical device cybersecurity threats to patients.
While the PEAC was announced in 2015, it did not form until 2017. The committee reflects the FDA’s cultural shift to not only allow some products on the market based on patient preference information, but also develop regulations that attempt to incorporate the patient voice. (Also see "FDA Launches Patient Engagement Advisory Committee For Devices" - Medtech Insight, 22 Sep, 2015.)