Transparency and communication have been popular catch phrases for FDA of late. In addition to launching a transparency initiative and a blog to increase interaction with industry and the public, the agency released this week a report that makes communication one of seven priorities for the Center for Drug Evaluation and Research (CDER). The report, Identifying CDER’s Science and Research Needs, discusses internal research initiatives and goals for contributing to the agency’s overall regulatory science efforts. In doing so, it identifies seven areas of regulatory science that are in need of improvement, and one focuses specifically on evaluating “the effectiveness and impact of different types of regulatory communications to the public and other stakeholders.”
In general, the Center would like to determine whether its various methods of communicating drug information to patients and doctors is effective and whether that information has an impact on healthcare provider behavior and, thus, on patient outcomes. The report highlights three areas in this regard: labels, emergency communication, and risk communication.
The first area focuses on drug information included in drug product labels and package inserts. Understanding these labels is especially important for consumers of over-the-counter drugs, which are self-selected and administered by patients without the help of a healthcare provider. Labels are designed and written to help prevent adverse events caused by improper dosage and administration [see back story]. The report states that because pharmacies may not “consistently provide appropriate content…FDA will take over regulation of this communication.”
CDER would like to look at how consumer perception and behavior vary in terms of understanding drug product labels and information. “ There are also questions about the presentation and comprehension of more complex information to both consumers and providers,” states the report. By working with industry, academics, and other groups, CDER would like to obtain and use enhanced understanding of this information in order to outline future strategies for dispensing medications. It’s unclear from the report, however, what CDER has in mind for taking over regulation of pharmacy-provided content. The Federal Trade Commission oversees direct-to-consumer over-the-counter advertising.
The second communications area outlined in the report is emergency communication. It talks about finding better ways to communicate with the public in certain situations, such as the outbreak of the H1N1 influenza. CDER also would like to improve coordination with other government agencies in this regard.
Risk communication is the third area identified by the report as a need for improvement. “We need to more thoroughly evaluate the ‘Drug Safety Communication (DSC),’ our primary communication tool for disseminating information about a newly identified, postmarket drug risk,” states the report. This research should include looking at the effectiveness DSCs with intended audiences, the effectiveness of the DSC format, reader/audience comprehension of the DSC messages, and any impact on behavior regarding decisions to take or stop a medication, according to the report.
Improving communication in any industry is always a good idea and the technology and tools available today lend themselves greatly to this type of work. Resources and time, however, are key factors into any achieving any goal and as we know, FDA is lacking in these two areas due to budgetary constraints. CDER is asking for feedback on its report and how the goals outlined above, among others, may be improved. Companies and organizations should submit their ideas for the good of the overall industry.