The US Food and Drug Administration (FDA) is, first and foremost, a public health agency responsible for regulating the safety and efficacy of healthcare products. But central to that mission is how it communicates with the public about those products, something made even more complicated with the advent of new technologies.
These difficulties are put on display in a new report just published by FDA, which notes that the last two decades have seen the development of Internet-driven technologies like social media, web-distributed presentations, and mobile devices. The report, Ensuring Access to Adequate Information on Medical Products for All, places a particular emphasis on answering one question: How can the agency make sure information reaches all subpopulations in the US, and not just the most common ones?
"Communicating to underrepresented subpopulations, including racial subgroups, is particularly challenging for FDA because members of these subgroups may be difficult to reach and because of potential literacy, language, or privacy issues," the agency explains in the report. So, for example, if FDA releases an important drug safety alert regarding a widely used drug in English, US citizens who speak Spanish may not receive that warning. If it only reaches out to the public through traditional media, it may miss a generation of people who have grown up using social media.
The crux of FDA's problem, it says it that it "competes with many other sources of information for [its] stakeholders' time and attention."
Three aspects were identified as being especially problematic: the use of plain language to describe difficult concepts, making sure communications are available in appropriate languages, and making sure the intended audience is literate in the necessary healthcare terminology used in an announcement.
Report Conclusions, Going Mobile
As part of the report, which Congress ordered under Section 1138 of the Food and Drug Administration Safety and Innovation Act (FDASIA), FDA said it came to five conclusions regarding how it can better communicate with the public at large, and subpopulations in particular:
- targeting outreach to those serving underrepresented patient subpopulations
- developing a "language access plan" to reach people with limited English language skills
- including underrepresented subpopulations in FDA's Patient Network and Health Professional Network
- continuing research into health literacy and FDA safety messaging
- increasing the use of social media platforms
The report also makes a quiet but significant announcement: FDA is preparing to launch a new mobile website optimized for viewing on smartphones and tablet devices. At present, the site is not mobile-friendly, displaying the same webpage at a much smaller scale to fit the diminutive size of the mobile device's screen.
The report is also open to comment for 60 days through a to-be-established docket in the Federal Register.
Federal Register Notice