The FDA is considering the creation of an Office of Patient Affairs, focused on soliciting the perspectives of patients and taking those insights into account as it sets regulatory policy.
The move grows out of a provision in the Food and Drug Administration Safety and Innovation Act (FDASIA), signed into law by President Obama in 2012. FDASIA instructs 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." The FDA put out a request for comment in 2014 asking how best to satisfy this requirement, and is proposing the new office as a result of comments it recieved.
The agency wants to learn about patients' attitude toward the risk-benefit balance for new drugs and devices, wants to better understand how to most effectively solicit patient input, and wants to explore how to best support patients and their advocates in their efforts to understand regulation.
"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 FDA writes in the Federal Register. "In order to improve the transparency, coordination, and implementation of FDA's patient engagement activities, the responsibilities of this central office would include: 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."
In the digital health realm, the FDA has worked directly with patients in the past in cases where patients are DIY-ing disease management solutions, thus skirting traditional regulatory pathways. Last year, leaders of the Night Scout project for DIY diabetes management systems penned an editorial in JAMA detailing some of their experiences with the agency. The FDA also waded into one of the biggest debates in the patient advocate community last summer when the agency issued guidance recommending that medical device companies give patients access to their own data. Similar cases to these could fall under the Office of Patient Affairs in the future.
Additionally, though, the FDA has always solicited and received input from patients, Bradley Merrill Thompson, a partner at Epstein Becker Green who specializes in the FDA, told MobiHealthNews. The problems are that (1) the FDA's mechanisms for soliciting feedback, like public comments online and at in-person meetings, haven't always been the easiest for laypeople to use, and (2) there has historically been a tendency in the agency to focus on hard data and write off patient experiences as anecdotal. Thompson thinks this could be a good way to surmount those obstacles.
"This office will be staffed presumably with people who are good at working with the general public, and explaining the FDA process, and engaging people in a true dialogue such that FDA can discern the real value in the patient experience and the patient perspective," Thompson wrote in an email. "At the end of the day, there are not simply correct and incorrect scientific conclusions based purely on scientific evidence. All of FDA's decisions are frankly laced with value judgments, and those value judgments are often predicated on what we think is best for patients. So what could be better than hearing from patients themselves about those value judgments? ... If done well, this initiative will do much to improve the communication and result in valuable intelligence and perspective gleaned from the patient community."
The FDA will collect comments on the proposal until June 7. However, a new commissioner under the Trump administration, which has made a point of cutting down the amount of bureacracy in the executive branch of the federal government, could stop the effort in its tracks.Nike Resurrect the Air Vortex From 1985