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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.
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:
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:
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:
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:
Co-branding arrangements do not and are not intended to transfer to either party any rights in any technology or intellectual property.
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.
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.
Date Posted: December 1, 2008