Industry Supports FDA Proposal to Create New Office of Patient Affairs
Industry groups BIO and TransCelerate, as well as companies GlaxoSmithKline and Shire, have offered their support for the creation of a new office at the US Food and Drug Administration (FDA) focused on patient affairs.
The idea for the new Office of Patient Affairs (OPA), proposed in March, is part of the agency’s efforts to offer "a single, central entry point to the Agency for the patient community," as well as "triage and navigation services for inbound inquiries from patient stakeholders."
The office would likely host and maintain data management systems to incorporate and formalize knowledge shared with FDA by patient stakeholders and FDA's relationships with patient communities, and the office would be part of efforts to develop a scalable platform for communicating online with patient stakeholders.
Nonprofit industry research collaborative TransCelerate Biopharma said it is "supportive of the objectives" of the proposed new office, and enhancing engagement with "a more transparent, accessible and robust experience for patient communities into the medical product development process."
Similarly, BIO said it supports FDA’s proposed establishment of a central OPA, noting "a need for patient engagement infrastructure that benefits all [FDA] Centers and OPA should be ideally situated to take on this work."
Shire also said it is "strongly supportive" of FDA’s proposal and "agrees it could serve as a focal and coordinating point for patient-related activities within the Agency while facilitating patient access to FDA to enable knowledge-sharing. Having a highly visible and clear centralized mechanism to engage FDA is of particular importance for patients and patient advocates for rare diseases, since many are unaware of available opportunities for engagement or mechanisms to do so."
GSK, which similarly threw its support behind the creation of OPA, also said the office could take on responsibilities developing relevant FDA Manuals of Processes and Procedures, coordinating shared objectives across various FDA offices, linking up with other government agencies and serving as a regulatory center of excellence on patient engagement to promote the adoption of best practices and harmonization of guidance documents.