- The Food and Drug Administration (FDA) is in talks to create an Office of Patient Affairs to support the agency’s patient engagement efforts and to manage patient input and suggestions.
On March 14, 2017 the FDA published a public docket in the Federal Register soliciting stakeholder feedback for the endeavor. The agency outlined its plans for the Office, stating that it would carry out the FDA’s responsibilities to consult with patients and other patient care experts in medical device and pharmaceutical regulation.
“FDA has long recognized the importance of engaging with patients, caregivers, and their advocates in the medical product development process,” the FDA says.
“Under this proposal to enhance mechanisms for patient engagement at FDA, a new ‘Office of Patient Affairs’ would be directly accountable to the medical product Centers through clear governance structures.”
The Office of Patient Affairs would increase FDA transparency and help manage patient and stakeholder input. The Office would also be in charge of soliciting feedback from patients and their advocates.
Specifically, the Office of Patient Affairs would be tasked with the following:
- Offering a single, central entry point to the Agency for the patient community,
- Providing triage and navigation services for inbound inquiries from patient stakeholders,
- Hosting and maintaining robust data management systems that would incorporate and formalize knowledge shared with FDA by patient stakeholders and FDA's relationships with patient communities, and
- Developing a scalable and forward-looking platform for communicating with patient stakeholders, particularly online channels
Per the proposal, the Office of Patient Affairs would undergo regular evaluation to ensure it is carrying out its patient-centered responsibilities.
“This evaluation will include feedback from external stakeholders (including patients and their advocates) on a biennial basis to best ensure the Agency's ongoing responsiveness to the needs of patient communities,” the FDA explained.
The FDA created the Office of Patient Affairs in response to the 2012 FDA Safety and Innovation Act (FDASIA).
FDASIA gives the FDA the power to expand public health and strengthen medical device development safeguards. Under those imperatives, the agency may collect stakeholder input when regulating medical devices and pharmaceuticals.
Specifically, the FDA says parts of that law calls for the HHS Secretary to "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."
In November 2014, the FDA posted a public docket in the Federal Register to help develop its goals for boosting patient centeredness at the agency and implementing this portion of FDASIA. The FDA eventually developed the following:
- Develop a nuanced understanding of the patient experience of disease by:
- Gathering patient perspective on what is clinically meaningful,
- Assessing attitudes towards benefit-risk and tolerance of uncertainty, and
- Enhancing the science of eliciting and integrating patient input.
- Support patients and their advocates in understanding regulatory processes and navigating the FDA by:
- Communicating relevant FDA positions, procedures, and activities,
- Connecting patients and their advocates with the appropriate resources, and
- Resolving discrete challenges and needs
From there, the FDA began conceiving the Office of Patient Affairs.
“To achieve these objectives, the Agency is considering establishing a central ‘Office of Patient Affairs’ which will be tasked with supporting and coordinating patient engagement activities across medical product centers and other offices that engage with patients and their advocates on matters pertaining to medical products,” the agency said.
Stakeholders may submit public comments by June 12, 2017.