January 8, 2018Regulatory
According to FDA Voice, the FDA is committed to collaborating with patients, caregivers, and advocates, as well as incorporating the various perspectives from these groups into the FDA's regulatory decision-making processes. In fact, members of the patient and stakeholder communities commented in public feedback on Section 1137, Patient Participation in Medical Product Discussions, of the Food and Drug Administration Safety and Innovation Act (FDASIA). Stakeholders recommended that the FDA create an outside group to provide input on patient engagement across the agency. FDA has announced that in response to that feedback and to accelerate the FDA's efforts in this area, it has published a request for nominations to join the FDA's Patient Engagement Collaborative (PEC). The PEC will be coordinated by the FDA and the public-private partnership, the Clinical Trials Transformation Initiative. FDA is seeking a group of diverse representatives from the patient community to participate in the PEC including:
1. Patients who have personal disease experience
2. Caregivers who support patients, such as a parent, child, partner, other family member, or friend, and who have personal disease experience through this caregiver role
3. Representatives from patient groups who, through their role in the patient group, have direct or indirect disease experience
The PEC will provide an ongoing forum to discuss how to achieve more meaningful patient engagement in medical product development and other regulatory discussions. Topics to be discussed may include making patient engagement more systematic; how to improve transparency, education and communication; new strategies for enhancing patient engagement; and new models for patients to collaborate as partners in the medical product development and FDA review process. The PEC builds on the agency's existing patient engagement efforts, such as the Patient Focused Drug Development meetings (for drugs and biologic products) and the Patient Preference Initiative (for medical devices).
The new collaborative will be modeled after the European Medicines Agency's Patients' and Consumers' Working Party (PCWP) which has enabled the Agency to build upon its existing interactions with patients and consumers. Examples of PCWP accomplishments include having patients review information on medicines ahead of publication to ensure that the information is clear and relevant, deciding on the eligibility criteria for patient and consumer groups who will be working with EMA, and involving patients as experts in EMA regulatory activities. The PEC will be spearheaded by the FDA's new Patient Affairs Staff (PAS) in the Office of Medical Products and Tobacco (OMPT), which is responsible for the coordination of agency-wide and cross-center projects related to patient engagement. The PAS will work closely with the medical product centers, the Office of External Affairs (OEA), and other offices across the agency to complement and support ongoing patient engagement efforts. Specifically, the PAS will focus on the following key areas:
1. Creating and assisting with public and private collaborations and partnerships with external groups of patients to discuss topics around medical product development and regulatory policies
2. Coordinating cross-cutting programs and activities to leverage best practices and enhance patient engagement
3. Facilitating consistent cross-center policy-making and common standards to enhance integration of patient perspectives into the regulatory and scientific process
4. Building a framework for hosting and maintaining a shared database of patient engagement information
5. Providing navigation services to triage inquiries from patients and patient organizations
6. Establishing a centralized point of entry into the FDA for patients and their advocates (existing FDA interactions will not be affected)
7. Enhancing our external communication platform to create awareness of the FDA's patient engagement activities and regulatory processes
This new Collaborative is also facilitated by provisions in both the 21st Century Cures Act of 2016 and the Food and Drug Administration Reauthorization Act of 2017. Both sought to foster patient participation and incorporate patient experiences in the regulatory process. The goal of the nomination process announced today is to identify individuals interested in serving as members of the PEC.