Patient care is the focal point of everything we do at Connexion Healthcare—clear, precise communications is how we do it. Optimizing patient care is likewise meant to be at the center of FDA healthcare regulatory processes. But when it comes to “synthesizing complex information into clear communications,” the FDA has possibly often fallen short, at least from the patient perspective. The central role of patients, too, perhaps has not always been adequately acknowledged. The part that most patients play in regulatory activities tends to be seen as necessarily passive: patients receive the benefits of, but often haven’t been able to actually help shape, the regulatory processes that most affect them.
That is changing now, with the inauguration of the FDA’s Patient Network Web site, launched on April 23, 2013.
One objective of the Web site is to make complex regulatory terminology accessible for patients, while explaining labyrinthine regulatory processes in ways that are concise and straightforward. The FDA’s Patient Network also focuses on those topics that are of the greatest interest to patients: what are the new drug approvals, how to enroll in clinical trials, how to get in touch with regulators, to name just a few.
Most impressive, however, is that the Web site invites patients to become actively involved in FDA regulatory processes— by becoming a “patient representative,” a type of consultant for regulatory review divisions and advisory committees. As such, these individuals help to bring the perspective of the patient community to the table. Although the FDA has in fact had a “Patient Representative Program” since the early 1990s, its earlier criteria were considerably more stringent; for example, even as recently as 2010, candidates were required to have prior experience as a patient advocate, as well as formal affiliation with a patient advocacy program. Accessing information about the program could be difficult, as its Web page was tucked deep within the recesses of the fda.gov Web site. Now, by contrast, the FDA Patient Network promotes this program front-and-center on its homepage, and the criteria for candidacy are clearly meant to draw in, rather than exclude, interested individuals with the capacity to make a difference. “Personal experience with the disease,” “the ability to be objective,” and a “willingness to communicate [your] views” are almost all that’s required to have a voice as a Patient Representative. The FDA itself offers whatever other training is necessary, including easily accessible webinars.
The FDA Patient Network is by no means a simple publicity/Web site make-over. The FDA Safety & Innovation Act, enacted in July 2012, mandates that the FDA increase patient participation in medical product regulation. In addition, the Prescription Drug User Fee Act V, likewise enacted last year, has called for Patient-Focused Drug Development, an “expansive approach to obtaining the patient perspective [. . .] on unmet medical need,” intended to benefit the drug review process.
As FDA Commissioner Margaret Hamburg explains in the FDAVoice blog post of April 23, “[The FDA Patient Network Web site] ushers in a new era of access and input for patients and consumers that will evolve with the needs of both communities.”
A strong tie-in exists between “knowing” and “doing”— and between clear communications and taking action. What’s more, this relationship isn’t one-way, but reciprocal. As patients become increasingly empowered to help direct the course of healthcare regulations, the need to speak to them on their own terms, and to reach them with clinically meaningful messages, becomes an imperative.