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Problem | Desired Outcomes | Key Strategies | FY 2004 Goal Highlights | Current Status | FY 2001-2002 Highlights

Problem

Clear and effective communication between FDA and its constituents is vital to FDA's mission as a public health agency. Consumers and health professionals need timely information in order to make informed decisions regarding diet, nutrition, and safe and effective health care.

Desired Outcome

Ensure that consumers, health professionals and other FDA stakeholders have accurate and timely information about potential benefits and health consequences associated with the products regulated by FDA; and a transparent view of FDA processes. Substantially improved public health outcomes should be achieved when well informed consumers and health professionals use safe, high quality products.

Key Strategies

Four key strategies are necessary for effective communication with Agency constituents:

1. Develop a thorough understanding of what information constituents need in order to make wise product choices;
2. Develop and implement appropriate communication vehicles and content to satisfy the needs of different constituent segments;
3. Assure that information communicated to constituents is based on sound scientific evidence; and,
4. Determine the impact of FDA communications on constituent understanding, behavior and ultimately on health outcomes. This fourth strategy provides the necessary feedback to adjust future communication strategies.

FDA's communication approach must consistently factor in the technical complexity, uncertainty of information, urgency of decisions, different levels of scientific understanding and perceptions of risk.

Although FDA interacts with many different constituencies, the following illustrations identify planned FDA initiatives that target consumers. In each of these initiatives, FDA's four key strategies will be addressed.

Working With Other Federal Agencies to Clarify Consumer Information

FDA will take advantage of opportunities to work with other public sector agencies to build effective communication strategies. For example, FDA will:

• Partner with the Federal Trade Commission (FTC) to best determine how to improve the quality and impact of information disseminated through direct to consumer advertising and other communication forums;
• Work with the FTC to identify an efficient and reliable review process for new health claims on food products;
• Coordinate with the National Institutes of Health (NIH) regarding the development of "off patent" drugs for use in children, and negotiate labeling concerns with listed drug holders and if necessary identify product labels requiring appeal activity and present to the Advisory Subcommittee; and,
• Hold meetings with other federal agencies, including: FTC, CDC, EPA and NIH to design inter-agency communication approaches that will enhance the effectiveness of FDA consumer strategies.

Providing Timely Information on Product Recalls to Consumers

FDA is in the process of developing and implementing an internet-based Recall System (RES) that will allow both industry and consumers faster and more accurate access to information.

Performance Goal Highlights for FY 2004

FFDA is committed to improving the way information is shared between the Agency and its constituents. Beginning in FY 2004, goals will be developed to further strengthen the Agency's capability to provide more effective consumer information. FDA's existing goal in this area is:

• Enhance the transparency of the National Antimicrobial Resistance Monitoring System (NARMS) program to stakeholders, the public, and other interested parties by increased reporting and communicating of NARMS results and program information.

Current Status

Dietary Supplement Health and Education Act (DSHEA) - FDA is in the process of using a nationwide media campaign to inform consumers how to use new food and nutrition labeling. This initiative has three related actions: Issuing guidance on qualified health claims for conventional foods and dietary supplements; Strengthening enforcement of dietary supplement rules of 1994, Dietary Supplement Health and Education Act (DSHEA) and establishing an FDA task force on Consumer Health Information for Better Nutrition. This task force will develop a framework to help consumers obtain accurate, up-to-date and science-based information about conventional food and dietary supplements.

Best Pharmaceuticals for Children Act (BPCA) - On January 4, 2002, Congress enacted the Best Pharmaceuticals for Children Act (BPCA), Public Law 107-109, to continue providing incentives for the effective development and dissemination of information on how to properly use therapies in children. One of FDA's roles following review of pediatric studies is to disseminate appropriate information to health care professionals.

Work With Other Public Sector Agencies - The Division of Federal-State Relations (DFSR) within the Office of Regulatory Affairs participates in cooperative and educational efforts designed to inform, interact with, and serves as the focal point for cooperating state and local officials, and associations of these state officials, to promote cohesive and uniform policies and activities in food and drug-related matters.

Highlights of FY 2001-2002 Accomplishments

To ensure successful public health outcomes, FDA leadership continued to encourage FDA programs to engage their stakeholders in formulating ways to accomplish the Agency's mission. FDA programs have been involved in various collaborations and initiatives. Some of these are provided below:

• Risk Management Communication and Education - FDA partnered with the National Association of Chain Drugstores and 80 national organizations to distribute million of copies of the brochure, "My Medicines," to women to educate themselves and their families about using medicines wisely.
• Targeted Collaboration on Critical Health Issues - FDA along with the National Institutes of Health, Centers for Disease Control and Prevention (CDC), American Red Cross, American Association of Blood Banks, and state agencies participate in setting standards and developing health education.
• Shared Surveillance Networks - FDA partnered with CDC and the U.S. Department of Agriculture to develop the National Antimicrobial Resistance Monitoring System. This system helps to detect whether foodborne pathogens are developing resistance to drug treatment.
• Cooperative International Standard Setting - FDA participated in the International Committee for Harmonization, International Standards Organization, Codex Alimentarius, and the World Health Organization to ensure that U.S. interests are upheld in establishing standards for products under the Agency's regulatory purview.
• FDA's web-site has received a Bronze Award in the "Health Promotion/Disease & Injury Prevention Information" category of the latest WWW Health Awards competition. This twice yearly contest is sponsored by the Health Information Resource Center, which holds the competition to provide "a seal of quality for electronic health information." A panel of health experts judge entries for content, format and overall quality.
• FDA's CDRH Division of Communication Media received the 2002 OMNI - BRONZE award for "Communication Skills for Regulators".
• FDA Conducted three laboratory research programs and performed the corresponding research in connection with the mission of Product Quality Research Institute (PQRI); Oral Biopharmaceutics, Drug Product, and Drug Substance.
• FDA issued and posted the Draft Guidance for Industry: Inhalational Anthrax (Post-Exposure) - Developing Antimicrobial Drugs (dated March 18, 2002).

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