• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

About FDA

  • Print
  • Share
  • E-mail

MOU 225-10-0021

 

MEMORANDUM OF UNDERSTANDING
BETWEEN
U.S. FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES,
MEDSCAPE, LLC AND WEBMD LLC (each a "Party" and collectively the "Parties")
 
I. Purpose
 
This Memorandum of Understanding (MOU) defines the framework in which the
Food and Drug Administration (FDA) will provide publicly available content to
be used in health professional informational, educational, and training programs
that will be run by WebMD LLC ("WebMD") and Medscape, LLC ("Medscape"),
an entity accredited by the Accreditation Council for Continuing Medical
Education (ACCME), the American Nurses Credentialing Center (ANCC) and the
Accreditation Council for Pharmacy Education (ACPE) to provide continuing
professional education to physicians, nurses and pharmacists, respectively.
These programs will provide information, education and training for physicians,
nurses, pharmacists, and health professionals (collectively referred to herein as
"HCP’s") on medical product safety and efficacy issues and, in certain cases, will
offer HCP’s the opportunity to obtain continuing medical education (physicians)
and continuing education (nursing, pharmacy) credit (collectively, "CME") in
connection with such programs. This collaboration will complement FDA’s capacity
to educate and communicate with HCP’s.  It will also promote the timely
dissemination to HCP’s of accurate information on public health and emerging
safety issues and product safety recalls.
 
II. Background

 
The FDA is responsible for protecting the public health by assuring that foods are
safe, wholesome, sanitary, and properly labeled; biologics for human use and
human and veterinary drugs are safe and effective; there is reasonable assurance
of the safety and effectiveness of medical devices intended for human use;
cosmetics are safe and properly labeled;public health and safety are protected
from electronic product radiation; and tobacco products are labeled and marketed
in accordance with applicable statutes and regulations.
 
The FDA is also responsible for advancing the public health. FDA helps to speed
innovations that make medicines and medical devices more effective, safer, and
more affordable; and helps the public get the accurate, science-based information
they need to use FDA-regulated products to improve their health ("FDA Health Information").
 
Through their respective online portals and mobile applications (collectively, the
"WebMD Health Professional Network"), Medscape and WebMD offer HCP’s a
variety of information resources and communications services including, but not
limited to, peer-reviewed original medical journal articles, CME, a customized
version of the National Library of Medicines MEDLINE database, daily medical
news, major conference coverage, and drug information including a drug
database (Medscape Drug Reference, or MDR) and drug interaction checker and
Medscape Physician Connect, a physician-only social network.
 
III. Authority
 
FDA has authority to provide information to the public pursuant to section 705(b)
and section 903(d)(2)(D) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C.
§§ 3 75(b) and 393(d)(2)(D).
 
IV. Substance of Understanding
 
FDA will work with Medscape and WebMD, as applicable depending on the
nature of the services being developed, to define approaches for web links, the
delivery and sharing of content, and CME program assessment, development and
delivery protocols in order to facilitate the dissemination of FDA Health
Information. As part of this effort, FDA and Medscape will identify FDA public
health and product alerts, guidance, service descriptions and educational programs
for HCP’s.
 
V. General Provisions
 
A. This MOU does not grant exclusivity to either Party, nor does it restrict FDA,
Medscape or WebMD from participating in similar initiatives with other
public or private agencies, organizations or individuals.
 
B. FDA Health Information must be easily distinguishable from non-FDA
content on Medscape and WebMD web pages. FDA Health Information
placed on Medscape and WebMD web pages should be clearly identified as
such.
 
C. Printed and online web pages containing FDA Health Information provided by
FDA pursuant to this MOU must be free of advertisements, and otherwise
must avoid implying FDA’s endorsement or support for a particular product,
service or website.
 
D. FDA, Medscape and WebMD recognize that this MOU is not intended to, 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, Medscape or
WebMD.
 
E. All materials and programming produced pursuant to this collaboration must
be accessible by and free of cost to the general public.
 
F. 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, Pub. L. No. 105-220, Aug. 7, 1998 (see U.S.
Department of Health and Human Services policy on section 508 compliance
at http://ww.hhs.gov/od/5 08policy/index/html; and Office of Management
and Budget policies for protecting private information at
www.usa.gov/webcontent/reqsbestpractices/lawsregs/prjvacy/shtml),
 
G. Both parties agree that content provided to Medscape or WebMD by FDA in
connection with the collaboration shall be public domain material and as such,
FDA shall have full rights to reuse such content for all FDA purposes and the
right to share with other collaborators or requestors.
 
H. Medscape and WebMD agree to maintain current FDA Health Information
within their web pages. FDA Health Information must be removed from
Medscape and WebMD websites in the following circumstances: (1) within
three years of the date of its first publication, unless an extension of a definite
term is agreed to by FDA in advance of expiration of the three-year period; (2)
upon termination of this MOU, if the MOU terminates less than three years
after the material is posted; (3) upon FDA’s request in circumstances in which
the information becomes outdated; or (4) as soon as is commercially
practicable but no longer than 72 hours after receipt of FDA’s written request
to remove the material, regardless of reason. Medscape or WebMD ’S failure
to display current information or to remove information in accordance with
this MOU may result in termination of this MOU and related activities.
 
I.  FDA retains the right to review all materials produced through this
collaboration prior to WebMD’s or Medscape’s public distribution or posting
of such materials, and the right to prohibit the public distribution or posting of
such materials.
 
J.  Medscape and WebMD will include the following disclaimer language in a
clearly distinguishable manner on any web pages on which FDA Health
Information provided by FDA pursuant to this MOU is placed: "Information
provided by FDA and/or its employees on this website is for educational
purposes only, and does not constitute medical advice. Any statement or
advice given by an FDA employee on this website does not represent the
formal position of FDA. FDA and/or any FDA employee will not be liable for
injury or other damages resulting to any individuals who view FDA-related
materials on this website." FDA reserves the right to modify this disclaimer
language.
 
K. FDA and Medscape and WebMD will cooperate in the maintenance of each
party’s trademarks and logos. Medscape and WebMD agree that they will not
use FDA’s logo for marketing purposes other than to promote activities
engaged in pursuant to this agreement. The use of FDA names and logos shall
not imply any exclusive arrangement. Any use of FDA logos must be
approved, in advance, by FDA’s Office of Special Health Issues and adhere to
published FDA logo policies (see
http ://www. fda, gov/AboutFDA/AboutThisWebsite/WebsitePolicies/ucm2 1811
6.htm).
 
L. This MOU does not and is not intended to transfer to any Party any rights in
any technology or intellectual property of any other Party hereto, other than
Medscape’s ability to display the FDA logo subject to the restrictions specified
under Paragraph J above. For avoidance of doubt, any intellectual property
including, without limitation, content, products, technology, data and other
information, provided by Medscape or WebMD for use in the collaboration
shall in all cases remain solely owned by Medscape or WebMD, as applicable,
and no license to use such information is granted under this MOU.
 
M.  FDA and Medscape and/or WebMD may in the future engage in activities
relating to certain funded activities. Those activities are entirely independent
of this MOU and shall in no respect be subject to any term of this MOU.
 
N. Except as required by law or regulation, including but not limited to
publication of this MOU and related materials in the Federal Register, neither
party will make any public announcement (including press releases) about this
MOU or the subject matter thereof without first obtaining the other party’s
prior written approval of such announcement.
 
VI. Resource Obligations:
 
All activities undertaken pursuant to the MOU are subject to the availability of
personnel, resources, and funds. Medscape and WebMD are not being
compensated by FDA for the activities conducted under the MOU, and funds are
not otherwise being obligated under the MOU. This MOU does not affect or
supersede any existing or future agreements or arrangements among the Parties.
This MOU and all associated agreements will be subject to the applicable policies,
rules, regulations, and statutes under which FDA, Medscape and WebMD operate.
 
VII. CONTACT POINTS
 
A. Food and Drug Administration
Anna Fine
Office of Special Health Issues
Office of External Affairs
U.S. Food and Drug Administration
301-796-8471
Anna.wojasfda.hhs.gov
 
B. Medscape, LLC or WebMD LLC
Amy Nadel
825 Eighth Avenue, 11 "’ Floor
New York, NY 10019
212-301-6727
anadel@rnedscape.net
 
VIII.  LIMITATIONS ON LIABILITY
In no event will any party hereto be liable to the other under any theory of
liability, however arising, for any costs or cover or for indirect, special,
incidental, or consequential damages of any kind arising out of this MOU.
The provision shall survive termination, cancellation or expiration of this
MOU or any reason whatsoever.
 
IX. Term, Termination, and Modification:
This MOU, when accepted by all Parties, will have an effective period of
performance from the date of the latest signature until three years and may be
modified or terminated by mutual written consent by both Parties. Any party
may terminate the agreement at any time, but such Party should provide 60-
day advance written notice to the other Parties of such termination.
 
By signing below, the Parties accept the conditions that accurately represent the
understanding reached between them.
 

Approved and Accepted
for the Food and Drug Administration

Signed by: Margaret A. Hamburg, M.D.
Commissioner of Food and Drugs
 

Date: June 8, 2011

Approved and Accepted
for Medscape, LLC

Signed by: Ezra T. Ernst
Senior Vic-President, General Manager

Date: May 19, 2011

 

Approved and Accepted
for WebMD LLC

Signed by: Steve Zatz, MD
Executive Vice-President
WebMD Health Corp.

Date: May 19, 2011

 

 Amendment 1

MEMORANDUM OF UNDERSTANDING BETWEEN
U.S. FOOD AND DRUG ADMINISTRATION
DEPARTMENTOF HEALTHAND HUMAN SERVICES
MEDSCAPE, LLCAND WEBMD LLC (each a "Party"and collectivelythe "Parties")
 
 
 
This is an amendment to the Memorandumof Understanding(MOU) number 225-10-0021 to grant an additional five years to the agreement beginning June 8, 2014 and continuing until June 9, 2019. The time extension is permissible under Section IX Term, Termination, and Modificationof the MOU. The purpose of the time extension is to provide for continuityin the collaboration.
 
All other contentof the MOU Number 225-10-0021 executed on June 8, 2011, remains unchanged.
 
Approved and Accepted
U.S. FOODAND DRUGADMINISTRATION
 
Heidi C. Marchand
Assistant Commissioner for Health and Constituent Affairs
 
May 1, 2014
 
Approvedand Accepted
MEDSCAPE, LLC, AND WEB MD LLC
 
Jo-Ann Strangis, Senior Vice President
 
April 20, 2014