By McKenzie E. Cato* & James E. Valentine –
FDA’s Center for Devices and Radiological Health (CDRH) recently announced in the Federal Register and the FDA Voice blog that it has scheduled the first-ever meeting of the Patient Engagement Advisory Committee (PEAC), which will provide recommendations to FDA regarding the regulation of medical devices and the use of devices by patients.
This initiative is the result of 2012 legislation, section 1137 of the Food and Drug Administration Safety and Innovation Act (FDASIA), and public input that FDA solicited in response to it (see prior blog post here and FDA report here). This provision added section 569C (“Patient Participation in Medical Product Discussion”) to the Federal Food, Drug, and Cosmetic Act (FDC Act). It states: “The Secretary shall develop and implement strategies to solicit the views of patients during the medical product development process and consider the perspectives of patients during regulatory discussions. . . .” FDC Act § 569C(a)(1).
The topic of the first PEAC meeting, which will occur on October 11-12, will be patient input regarding medical device clinical trials. In particular, CDRH is seeking to (1) better understand challenges for patients in medical device clinical trials, (2) better understand how patient input is being used to overcome these challenges, and (3) receive recommendations from the PEAC on top areas for FDA to consider for action. The nine members of the PEAC include patient advocacy experts, patient representatives, consumer representatives, and directors of patient advocacy organizations.
According to the FDA Voice blog post announcing this meeting, FDA chose the topic of medical device clinical trials for the inaugural PEAC meeting because “patients often have concerns about participating in clinical trials or drop out once they have enrolled in a trial.” This, says CDRH, has the effect of making it more difficult to reach reliable conclusions in device trials and it can delay public access to technological advances.
The PEAC is the latest effort in the Agency’s larger shift towards inserting the patient voice into regulatory decision-making arising out of its implementation of section 1137 of FDASIA. Just last month, FDA’s Office of Health and Constituent Affairs (OHCA) announced it would be working with the Clinical Trials Transformation Initiative (CTTI) to create a work group with patient advocacy organizations, modeled after the European Medicines Agency’s Patients’ and Consumers’ Working Party, to talk about patient engagement at FDA.
We have been following closely CDER/CBER’s Patient-Focused Drug Development (PFDD) Initiative, a commitment under the fifth authorization of the Prescription Drug User Fee Act (PDUFA V) (see prior blog posts here and here), including a very successful parallel externally-led PFDD meeting program (see prior post here). By comparison, CDRH has been slower to provide formal, more direct opportunities for patient engagement as part of medical device regulatory decision-making.
Last September, CDRH and CBER finalized a guidance document on the inclusion of patient preference information in premarket approval applications, humanitarian device exemption applications, and de novo requests (see blog post here). However, since that guidance was finalized, the option to include patient preference information in certain device submissions does not seem to have been widely embraced by industry. In contrast, the PEAC will allow for engagement with patients in a more structured environment, which will hopefully lead to broader influence on CDRH decision-making.
* Summer Associate