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  1. Advancing Regulatory Science

Section 8. Strengthen Social and Behavioral Science to Help Consumers and Professionals Make Informed Decisions about Regulated Products: Strategic Plan for Regulatory Science

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One way that FDA protects the public from harm and promotes public health is by ensuring easy public access to sound information 1 . This is accomplished by setting and enforcing high standards for product information and quality to ensure that labels are accurate, products truly are what their labels claim, and advertising about these products is clear, truthful, and in no way misleading. FDA also seeks to provide clear information about how to use products to promote health or reduce harm so consumers and health professionals can make informed decisions, and FDA communicates new or emerging situations so Americans have up-to-date information about products on the market.

To enhance the utility of information provided to the public, FDA needs a science-based approach for developing an effective communication strategy, including developing messages, testing how the public understands information, assuring optimal delivery to relevant populations, and assessing the impact of the information on public understanding, attitudes, and behaviors. A major challenge is adapting FDA’s communications to rapidly evolving technologies that are driving major shifts in how consumers choose to receive and share information.

Implementation Strategy

To facilitate the translation of science-based regulatory decisions and information into public health gains, FDA must strengthen social and behavioral sciences in the areas of understanding and reaching diverse audiences, ensuring audience comprehension, and evaluating the effectiveness of communications in changing behaviors related to the use of regulated products. FDA scientists are working internally or collaboratively to address the following needs:

  1. Know the audience:
    1. Improve understanding of how the multitude of factors related to the individual (e.g., age, sex, race/ethnicity, literacy, motivation, skills) and the information provided on or with products (e.g., wording, placement, required vs. voluntary) impact decision makers' responses to product, label, and agency-provided information.
  2. Reach the audience:
    1. Improve understanding of information channels and identify the most effective methods of delivering information to an intended audience, including audiences with diverse backgrounds;
    2. Identify the most effective methods to inform tobacco retailers about FDA's regulatory and enforcement authorities; and
    3. Expand understanding of how online media promote and advertise FDA-regulated products.
  3. Ensure audience understanding:
    1. Enhance understanding of how message format and content affect consumers’ and health professionals’ attitudes about regulated products;
    2. Assess how consumer perceptions of risks associated with FDA-regulated products are affected by product claims;
    3. Improve methods to convey complex scientific and quantitative information about product risks and benefits (e.g., quantitative risk information, clinical trial results, toxicology data) to consumers and professionals; and
    4. Understand how exposure to non-target messages (e.g., promotional offers, distractions in TV ads) affects consumers’ understanding of product information.
  4. Evaluate the effectiveness of communication about regulated products:
    1. Develop methods to identify and track public understanding, perceptions, and attitudes towards product-related information;
    2. Describe the impact of format and content on behaviors related to product use or misuse, including prescribing practices;
    3. Develop methods to rapidly assess public understanding and attitudes about recalls and other time-sensitive FDA messages to make timely adjustments to the information and/or channels when appropriate; and
    4. Determine the impact of FDA-regulated direct-to-consumer advertising on reporting of adverse events associated with product use.

Tobacco Regulation
Under the Family Smoking Prevention and Tobacco Control Act (P.L. No: 111-31), FDA is responsible for the regulation of the manufacture, distribution, and marketing of tobacco products. Following an experimental study that tested 18,000 adult smokers and susceptible youth on the relative effectiveness of various graphic health warnings, in June 2011 FDA launched new graphic health warning labels for cigarettes, marking a significant advance in communicating the dangers of smoking. These new labels mark the first change in cigarette warnings in more than twenty-five years. The nine new labels warn of risks such as addiction, cancer, and lung disease, and will be required on all new cigarette packages and in advertisements beginning September 2012.

Public Health Impact:

Strengthening social and behavioral sciences will allow FDA to better equip American consumers and health professionals with the information they need to make sound decisions about using, prescribing and dispensing products. This has the potential to decrease preventable adverse events related to FDA-regulated products.

1. Hamburg MA, Sharfstein JM. The FDA as a Public Health Agency. N Engl J Med 2009 Jun 11;360(24):2493-5.

Table of Contents: Strategic Plan for Regulatory Science

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