BIO Submits Comments to FDA on Enhancing Patient Engagement Efforts
BIO submitted comments to the Food and Drug Administration (FDA) on Enhancing Patient Engagement Efforts Across the Food and Drug Administration.
BIO applauds the FDA for its commitment to integrating patient perspectives into drug development and regulatory review processes. BIO also supports FDA’s proposed Office of Patient Affairs (OPA) to provide a more transparent, accessible, and positive experience for patient communities.
BIO agrees the proposed OPA could receive inquiries about and better coordinate patient-focused activities across the Agency, as well as play a transformative role in developing a forward-looking platform enabling patients and the scientific community to more easily obtain information about patient-focused drug development activities. OPA could also serve as a valuable resource for patients, patient advocacy organizations, and the larger scientific community.
BIO says OPA should ensure timely communication and transparency with sponsors by informing them how to incorporate patient perspective data into an Investigational New Drug Application (IND) and Marketing Application. Additionally, OPA should support and coordinate with pharmaceutical sponsors seeking to include the patient voice in drug development as well as benefit-risk assessments.
BIO provides additional recommendations on OPA governance, data management systems, and other clarifications.