The FDA is looking to step up its patient engagement efforts, FDA Center for Devices and Radiological Health Director Jeffrey Shuren said during the 1st meeting of the federal watchdog’s Patient Engagement Advisory Committee.
Shuren said that with MDUFA IV, the agency is now better equipped to move forward with patient engagement efforts, according to a Regulatory Affairs Professionals Society report.
“We’re now, for the first time, getting resources to build out a patient engagement group at CDRH. Prior to that, believe it or not, there were never dollars that had been allocated to us specifically for this kind of work,” Shuren said, according to RAPS.
The PEAC, which is primarily made up of patients and patient advocates, aims to provide the FDA with a better method of receiving patient input and data, Shuren commented.
“We have tried to include patients in our decision-making, but quite frankly the opportunities to engage are very, very limited,” Shuren said, according to the RAPS report.
Shuren commented that at public meetings, patients only gain 2 to 3 minutes to speak, and other hurdles have prevented the agency from receiving appropriate input from patients.
“We open up a public docket and you can provide comments, but how many people actually read the Federal Register?” Shuren said, according to the report.
Patient inclusion could be important for the regulatory body, as Shuren said it has seen a 500% increase in pivotal clinical trials for PMAs using patient reported outcomes. Over 50% of the agency’s PMAs now also include patient reported outcome data, Shuren added.
FDA CDRH clinical trials director Owen Faris said the federal watchdog is working to find ways to make clinical trials and the results more relevant to patients and to reduce hurdles that patients encounter during trials.
“We want the trial to be gathering information that’s relevant to the patients that are going to be impacted by the use of the device,” Faris said, according to RAPS. “If patients have to come back too frequently, or have to drive too far, or spend too much time in the hospital, or do something that’s really burdensome, we may get a lot of missing data.”