by Joanne McNelis, Ph.D., Scientist
In September the FDA announced the creation of its first-ever Patient Engagement Advisory Committee (PEAC) to advise the FDA commissioner on complex issues relating to medical devices, the regulation of devices, and their use by patients. This marks a major milestone in the FDA’s ongoing approach to foster a more “patient-centric” regulatory process.
The Food and Drug Administration Safety and Innovation act (FDAISA), passed by Congress in 2012, ordered the FDA to “develop and implement strategies to solicit the views of patients during product development and consider the perspectives of patients during regulatory discussions.” In response, the FDA executed several programs to obtain the views of patients during medical product development – largely through open public forums. The first of these initiatives, announced by the Center for Drug Evaluation and Research (CDER) in 2012, was the Patient-Focused Drug Development (PFDD) program – a series of at least 20 disease-focused public meetings to obtain patient perspective on specific diseases and their treatments. In 2013 the Center for Devices and Radiological Health (CDRH) launched a complementary program, the Patient Preference Initiative (PPI). With a similar aim to the PFDD, but for devices rather than drugs, the PPI enables the patient community and other interested stakeholders to weigh in on the benefit-risk tradeoffs of medical devices. Now, the establishment of the PEAC builds upon these previous initiatives by giving patients and patient advocates the opportunity to not only voice their opinions, but actually vote on the decision making process that impacts their lives. This is a particularly important change, as the recommendation of advisory committees historically have a great influence on the FDA’s decision to approve a new product. The PEAC will also allow FDA scientists to hear from patients early in the regulatory process, so that the FDA can make more informed decisions. The CDRH announcement states that the committee will consist of a core of nine voting members, “who are knowledgeable in areas such as clinical research, primary care patient experience, and health care needs of patient groups in the United States.” The committee may also include ‘‘an individual nominated by industry to serve temporarily as non-voting members’’, who will be selected by The Commissioner or a designee. The PEAC will discuss a number of important patient-related topics, including “Agency guidance and policies, clinical trial or registry design, patient preference study design, benefit-risk determinations, device labeling, unmet medical needs, available alternatives, patient reported outcomes, device-related quality of life or health status issues, and other patient related topics.” At the Regulatory Convergence Meeting in October, Stephen Ostroff, Acting Commissioner for Food and Drugs, voiced his support of the PEAC, “This advisory committee represents a new and exciting opportunity to foster patient partnerships with FDA, and it complements other efforts at FDA to bring the patient into the medical device regulatory process”. However, he also acknowledged that meaningful patient engagement was not without its challenges, “Patients have to understanding the regulatory framework, clinical trial designs and operational challenges, and the legal and practical limitations facing medical product developers”. Time will tell if, armed with this increased patient perspective, we will see a difference in the regulatory landscape for devices, and, ultimately, if this information will trickle down to industry and affect the types of devices seeking regulatory approval. http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM270412.pdf. http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm347317.htm http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/PatientEngagementAdvisoryCommittee/default.htm https://www.federalregister.gov/articles/2015/09/21/2015-23521/establishment-of-the-patient-engagement-advisory-committee-establishment-of-a-public-docket-request http://www.fda.gov/newsevents/speeches/ucm469673.htm