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Co-Branding of FDA Consumer Health Information

On this page:

• Purpose
• Background
• Requirements for Co-branding Arrangements
• Exclusion
• Point of Contact

I. PURPOSE

The purpose of this policy statement is to establish terms of collaboration between the Food and Drug Administration (FDA) and other public and private entities involving the co-branding of FDA Consumer Health Information. It defines the broad programmatic scope, policies and principles for providing linked and co-branded printed and Web-based editorial and visual communications materials.

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II. BACKGROUND

FDA recognizes the benefits of collaboration in carrying out its mission of promoting and protecting the public health and it strives to provide useful and credible information to consumers. This policy statement creates a framework that provides for co-branding of FDA's Consumer Health Information with outside parties. The overall goal of such partnerships is to empower the public to improve their health, safety and well-being by:

• Extending the reach of FDA Consumer Health Information;
• For web-based collaborations, encouraging consumers who visit a co-branded web page to seek additional FDA Consumer Health Information materials on FDA's own Web site;
• Increasing readership of co-branded information, as well as FDA's own materials; and
• Providing customers of co-branding organizations with better information and timely content concerning public health and safety topics including alerts of emerging issues and product recalls.

FDA is responsible for promoting the public health by promptly and efficiently reviewing clinical research and taking appropriate action on the marketing of regulated products in a timely manner. Under its authorizing statute, FDA is responsible for ensuring that: foods are safe, wholesome, sanitary and properly labeled; human and veterinary drugs are safe and effective; there is reasonable assurance of the safety and effectiveness of devices intended for human use; cosmetics are safe and properly labeled; and public health and safety are protected from electronic product radiation (21 U.S.C. 393). As part of its mission, FDA helps the public get the accurate, science-based information they need to use medicines and foods to improve their health.

These collaborations advance FDA's public health mission through:

• Increased outreach and readership of FDA Consumer Health Information;
• Increased capacity to share time-sensitive public health and product safety alerts; and
• Improved public understanding of FDA's roles and responsibilities in protecting and promoting public health.

FDA intends to apply its limited resources to co-branding arrangements on a case-by-case basis, consistent with the partner organization's documented ability to help FDA reach its goals for such partnerships. In determining whether to enter a co-branding agreement, FDA will consider the benefits it anticipates the agreement will provide in terms of empowering, educating and informing the public. The nature and scope of co-branding arrangements will therefore vary, depending on the mission, capacity, and reach of the organization entering into a partnership with FDA, as well as the mutual goals of such a partnership.

Appropriate collaborations will benefit co-branding organizations through:

• Access to FDA Consumer Health Information, including visual information, for their customers;
• Use of the FDA logo, unique graphical identifiers and standard statement of collaboration; and
• Increased outreach and readership of public health information.

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III. REQUIREMENTS FOR CO-BRANDING ARRANGEMENTS

FDA will consider all requests for co-branding arrangements consistent with the agency's guiding principles on leveraging (see www.fda.gov/oc/leveraging/principles.htm). In this document, FDA is setting forth specific criteria it will apply when considering requests to co-brand FDA Consumer Health Information. These requirements are intended to ensure the integrity and quality of how FDA Consumer Health Information is presented.

Organizations interested in a co-branding arrangement are required to submit a detailed proposal to:

Jason Brodsky, Director
FDA's Consumer Health Information Staff
Office of External Relations
Food and Drug Administration
5600 Fishers Lane, Room 15A-29
Rockville, MD 20857

Proposals should include a statement agreeing to the terms of the agency's co-branding policy statement and be signed by an individual authorized to act on behalf of the potential partner. FDA will carefully review all proposals.

FDA requests that all proposals meet the following criteria:

• FDA Consumer Health Information should be easily distinguishable from non-FDA content. Placement of FDA Consumer Health Information on the Web or in printed publications should be clearly identified as such. Examples of clearly identifying FDA Consumer Health Information would be placing this information in a box and/or using a distinct color to distinguish it from non-FDA content, and/or otherwise clearly distinguishing the non-FDA content via an adequate disclaimer statement.
• Printed and online pages containing FDA Consumer Health Information must be free of advertisements to avoid implying FDA's endorsement or support for a particular product, service or Web site.
• Co-branding arrangements are not exclusive. Entering into a partnership agreement does not restrict FDA from participating in similar initiatives with other public or private agencies, organizations or individuals.
• Co-branding organizations agree to comply with Section 508 of the Rehabilitation Act (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998 (P.L. 105-220), August 7, 1998 (see HHS policy on Section 508 compliance at www.hhs.gov/od/508policy/index.html); and Office of Management and Budget (OMB) policies for protecting private information (see www.usa.gov/webcontent/reqs_bestpractices/laws_regs/privacy.shtml).
• Co-branding arrangements are not intended, and may not be relied on, to create any right or benefit, substantive or procedural, enforceable by law by any party against the United States or co-branding organization.
• FDA and co-branding organizations will cooperate in maintenance of trademarks and logos. The FDA logo shall not be used for marketing purposes other than to promote the co-branded FDA Consumer Health Information. FDA names or logos, when used by the co-branding organization, shall not imply any exclusive arrangement. Use of FDA logos must be approved by FDA's Consumer Health Information Staff and adhere to published FDA logo policies (see www.fda.gov/graphics/FDAlogos1999/).
• Both parties agree that information FDA provides to co-branding organizations shall be public domain material. FDA shall have full rights to reuse the content for all FDA purposes, and the right to share with other collaborators or requestors.
• For on-line collaborations, co-branding organizations will agree to provide FDA with statistical information at least every 2 months on the number of users viewing FDA Consumer Health Information. FDA and each partner will jointly review this information to evaluate the effectiveness of the arrangement and to make any necessary adjustments in approach, which may include terminating the co-branding arrangement.
• Co-branding organizations agree to promote and to maintain current FDA Consumer Health Information. FDA Consumer Health Information must be removed in the following circumstances: (1) within 3 years of the date of its first publication; (2) upon termination of this Agreement, if the partnership Agreement terminates less than 3 years after the material is posted; (3) upon FDA's request in circumstances in which the information becomes outdated; or (4) as soon as commercially practicable but no longer than 72 hours after receipt of a written request from FDA to remove the material, regardless of reason. Moreover, co-branding organizations agree to ensure the most recent information on a particular topic is highlighted in an acceptable manner. A co-branding organization's failure to display current FDA Consumer Health Information may result in the termination of an agreement.

Co-branding arrangements do not and are not intended to transfer to either party any rights in any technology or intellectual property.

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IV. EXCLUSION

This co-branding policy statement does not apply to the republishing of FDA Consumer Health Information or linking to individual FDA Consumer Health Information articles, all of which are in the public domain. In these cases, "FDA Consumer Health Information (www.fda.gov/consumer)" should be acknowledged as the source.

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V. POINT OF CONTACT

The FDA official responsible for managing FDA Consumer Health Information co-branding arrangements is:

Jason Brodsky
Director, Consumer Health Information Staff
Office of External Relations
U.S. Food and Drug Administration
5600 Fishers Lane, Room 15A29
Rockville, Maryland 20857
PHONE: 301-827-6251
FAX: 301-827-5308
E-mail: jason.brodsky@fda.hhs.gov

This document appears on FDA's Consumer Health Information Web page (www.fda.gov/consumer), which features the latest updates on FDA-regulated products. Sign up for free e-mail subscriptions at www.fda.gov/consumer/consumerenews.html.

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Date Posted: December 1, 2008

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