Develop, evaluate, and use tools and methods to foster the creation and easy availability of clear and useful information about FDA-regulated products used by women to help women and their health care professionals make informed health-related decisions.
One of FDA’s strategic priorities41 is to provide consumers and health professionals with the information they need to make informed decisions about the use of FDA-regulated products. Research in this area should identify and evaluate methods for communicating FDA information, including product information and risk communications, to diverse subgroups of women. Research should take a comprehensive look at individual and situational factors that may influence the understanding and use of such information. Additionally, specific strategies should be explored for communicating risk–benefit information to any subpopulations who may find product use or risk information unclear (e.g., for limited English proficient speakers). Public health information cannot be useful to consumers if it isn’t tailored to the intended audience and easily accessible.
With a better understanding of how to create effective communication strategies to more effectively reach specific subpopulations of women, FDA can provide patients and their caregivers clear and useful health-related information.
Research in this area should help ensure that women receive product risk (e.g., toxicity, safety) and benefit information tailored to their needs. Health care professionals will also benefit from clear and readily available prescribing, dispensing, and product use information.
6.1 Identify how factors related to an individual (e.g., sex, gender, age, literacy level, native language) can affect a woman’s understanding of FDA product information and its influence on her subsequent health-related decisions
6.2 Evaluate the reach and impact of FDA communications about FDA-regulated products used by women, including but not limited to identifying and evaluating methods for communicating:
- FDA information to special populations of women, including elderly women, women with disabilities, caregivers, pregnant women, and women with limited English proficiency
- Specific information about sex and gender differences
- Risks of certain medical product exposures, food consumption (e.g., seafood), and the use of tobacco products during pregnancy
- Information about drug exposure during breast-feeding
6.3 Explore methods for using social media to identify gaps in knowledge, misinformation, or sentiments about specific women’s health issues and related FDA regulated products. Identify and evaluate possible issues related to how social media is being used by others to inform about FDA-regulated products.
41 See strategic priority # 8 of FDA’s Strategic Plan for Advancing Regulatory Science. Accessed September 2015.