MEMORANDUM OF UNDERSTANDING
BETWEEN THE FOOD AND DRUG ADMINISTRATION
I. PURPOSE AND GOALS
This Memorandum of Understanding ( "MOU") establishes a framework for a cooperative public education program ("Program") between two entities (each individually a "Party" and collectively the "Parties"): The Food and Drug Administration (FDA or Agency), Office of Communications (OCC), Office of External Affairs (OEA) and Healthline.com, a website owned and operated by Healthline Networks, Inc. The purpose of the Program is to provide and promote FDA information in the form of FDA Consumer Updates to consumers. This partnership offers high quality and timely content concerning public health and safety topics, including FDA alerts of emerging issues and product recalls.
FDA is authorized to enforce the Federal Food, Drug, and Cosmetic Act (the Act) as amended (21 U.S.C. 301, et seq.). In fulfilling its responsibilities under the Act, FDA promotes and protects the public health by assuring the safety, efficacy, and security of drugs, biologics, veterinary products, and medical devices. as well as the safety and security of foods, dietary supplements, cosmetics, and radiological products. FDA also has responsibility for regulating the manufacturing, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors. To accomplish its mission, FDA must stay abreast of the latest developments in medical research and communicate with stakeholders about complex scientific and public health issues.The collaborative development of research, education, and outreach partnerships with the Healthline.com will greatly contribute to FDA's mission.
Healthline.com’s mission is to make the people of the world healthier through the power of information. Healthline.com focuses its efforts on offering readers and visitors to the site objective, trustworthy, and accurate health information, guided by the principles of responsible journalism and publishing. Healthline.com's editorial philosophy is to use relevant and accurate content to promote a healthy lifestyle and facilitate disease prevention, as well as to offer clinically significant, medically reviewed information for those who are seeking answers to their health questions. Healthline.com’s goal is to educate and empower our users with relevant and responsible information in order to foster better communication between doctors and patients.
The Parties entered this MOU in mutual recognition of the need to empower consumerswith health information they can apply in everyday life.This MOU meets the requirements set forth in FDA's policy statement on co-branding of FDA Consumer Health Information, which is available online at https://www.fda.gov/ForConsumers/ConsumerUpdates/default.htm.
FDA and Healthline.com recognize that this MOU is not intended,and may not be relied on, to create any right or benefit. substantiveor procedural, enforceable by law by any party againstthe United States or against Healthline. com.
This MOU is authorized pursuant to FDA's authority to provide information to the public under sections 705(b) and 1003(d)(2)(D)of the Food, Drug and Cosmetic Act ("the Act") (21 USC 375(b), 393(d)(2)(D)).
IV. PROGRAM COMPONENTS AND ACTIVITIES
The components and activities of the Program are expected to increase FDA's capacity to disseminate FDA Consumer Updates, which contain time-sensitive public health and safety information. The Program will include the following components:
The Parties will determine cobranded FDA content for the healthline.com audience in four ways:
A. Develop a Healthline.com FDA Overview-Develop a single "Partnership Overview” page that provides:
- A descriptionof the partnership
- FDA descriptionwith links to FDA to "learn more" and "how to report a problem" destinations on the FDA site
- FDA descriptionwith link to FDA site where consumercan sign up to receive notices of new FDA Consumer Updates directly from the Agency.
- Descriptionsof importantFDA topics, such as recalls and food safety, with links to cobrandedFDA articles on Healthline.com
- A "top five articles” widget
- An alert sign-up widget
B. Develop FDA Topic Centers
Topic centers (which will have a similar design to Understanding Type 2 Diabetes will be created and will provide consumers with overviews and links to articles of interest. For topics already covered by Healthline.com (such as Cosmetic Safety and Food and Nutrition), Healthline.com will create a FDA topic page that will live among the other pages of the topic center. For topics the Parties elect to add and are not currently covered, Healthline.com will create a new topic center.
C. Develop FDA Article Pages
Individual article pages (which will have a similar design to Understanding a Type 2 Diabetes Diagnosis will be created and will provide unaltered FDA Consumer Updates including the following elements:
- Date, Attribution, FDA Branding and link to FDA website
- Article Content
- Alert Sign-Up Widget
- Navigation to Overview and Topic Pages
- Global Navigation
D. Develop Newsletters and Alerts Featuring FDA Content
Through our FDA sign-up widgets, consumers will receive either a bi-weekly newsletter of FDA content and immediate alerts for time sensitive information such as certain recalls.
E. Promotion and Website Integration
V. To promote both the content and the collaborative relationship (as defined in this MOU), the Parties will routinely promote new Consumer Update offerings through social communities on Healthline.com's Facebook and Twitter channels. FDA Consumer Updates will have a weighted ranking for search purposes on Healthline.com and search results on Healthline.com will visually highlight FDA Consumer Updates. A link to the FDA "Partnership Overview" page will be added to the footer that appears on all Healthline.com pages.
VI. TERMS OF THE MOU
A. FDA Consumer Health Information must be easily distinguishable from nonFDA content within the Program. Placement of FDA Consumer Health Information within the Program 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.
B. 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 website.
C. This MOU does not grant exclusivity to either Party. Neither Party is restricted from participating in similar initiatives with other public or private agencies, organizations, or individuals.
D. All activities within the scope of this MOU must 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 and Office of Management and Budget (OMB) policies for protecting private information.
E. FDA and Healthline.com will cooperate in maintenance of each Party's trademarks and logos. The FDA will not permit use of its logo for marketing purposes other than to promote the Program. The use of FDA names or logos shall not imply any exclusive arrangementFDA's Consumer Health Information Staff must approve any use of FDA logos, in advance. All cobranded content (webpages, email alerts, and email newsletters) must be easily distinguishablefrom non-FDA content. Healthline.com will use the FDA logo, disclaimers statements, and visual cues such as distinct coloring and boxes to distinguish cobranded content from non-FDA content.
Healthline.com will not use the FDA logo for marketing purposes other than to promote the co-branded FDA content.
F. Both Parties agree that information FDA provides to Healthline.com shall be public domain material and be available through access channels such as RSS Feed. FDA shall have full rights to reuse the content for all FDA purposes, and the right to share with other collaborators or requestors.
G. Healthline.com agrees to maintain current FDA Consumer Updates within the site and Program. FDA Consumer Updates must be removed from the Program in the following circumstances: (1) within 3 years of the date of its first publication; (2) upon termination of this MOU, if it 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. Hea!thline.com's failure to display current FDA Consumer Health Information may result in the terminationof this MOU.
H. This MOU does not and is not intended to transfer to either Party any rights in any technology or intellectual property.
FDA and Healthline.com will provide inbound and outbound links to and from the Program and the FDA's Consumer Health Information webpage.
FDA will not provide Healthline.com access to any document or information to the extent that providing such access would place the FDA in breach of the TradeSecrets Act, codified at 18 U.S.C. sec. 1905; the Privacy Act, codified at 5 U.S.C. sec. 552a; the Food, Drug, and Cosmetic Act, codified at 21 U.S.C. sec. 301, et seq (particularly 21 U.S.C. sec. 3310); FDA regulations (21 Code of Federal Regulations (CFR); or any other Federal law or regulation. VII.
VIII. LIAISON OFFICERS
A. Food and Drug Administration
Office of Communications
Office of External Affairs
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, Maryland 20903
B. Healthline.com or Healthline Networks, Inc. Tracy Stickler
660 Third Street
San Francisco, CA 94107
Each Party shall appoint a representative who shall act as the liaisons between such Party and the other Party's representative. A Party may update its representative upon written notice to the other Party.
IX. TERM, TERMINATION, MODIFICATION, AND ASSESSMENT MECHANISMS
This MOU, when accepted by all Parties, will be effective for five years from the date of signature by the later Party to sign it.At the end of the first year, and annually thereafter, as long as the MOU remains in force, the Parties will evaluate the effectiveness of the MOU in meeting their goals and may amend the MOU, continue it as written, or dissolve the MOU by mutual consent. In addition, at any time, the Parties may modify or terminate the MOU by mutual written consent, and either Party may terminate the MOU at any time by means of a written notice of termination.
At least every two months, Healthline.com will provide gratuitously, and with no expectation of reimbursement, statistical information to FDA concerning the reach of the Program. This information will include metrics on the newsletter, alerts, and the number of users visiting the "Partnership Overview" page and each individual content item and pages contained therein, as well information concerning the reach of the content integrated with Healthline.com's mobile platform and social media channels. The Parties agree that Healthline.com will provide information regarding usage to the FDA. This information will be jointly reviewed. The purpose of reviewing this information will be to evaluate the effectiveness of the collaboration and to make any necessary adjustments in approach, which may include termination of the partnership.
X. NO COMMITMENT OF FUNDS
All activities undertaken pursuant to the MOU are subject to the availability of personnel, resources, and funds. Nothing in this MOU shall be construed to obligate either Party to make payments to the other.
XI. LIMITATIONS ON LIABILITY
In no event will either Party be able to the other under any theory of liability, however arising, for any costs of cover or for indirect, special, incidental, or consequential damages of any kind arising out of this MOU. The provisions of this Section X shall survive termination, cancellation, or expiration of this MOU or any reason whatsoever.
XII. SIGNATURES OF RESPONSIBLE PARTIES
By signing this MOU, the responsible Parties agree to the terms and conditions of this MOU, and they further agree to adhere to FDA's policy statement on co-branding of FDA Updates.
Approved and Accepted for Healthline.com
Dean Stephens, CEO
September 30, 2014
Approved and Accepted for the Food and Drug Administration
Lawrence Bachorik, Ph.D.
Assistant Commissioner for Communications
Office of External Affairs
September 29, 2014