[Federal Register Volume 79, Number 117 (Wednesday, June 18, 2014)]
[Notices]
[Pages 34759-34760]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-14220]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0397]


Draft Guidance for Industry on Internet/Social Media Platforms 
With Character Space Limitations: Presenting Risk and Benefit 
Information for Prescription Drugs and Medical Devices; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a draft guidance for industry entitled ``Internet/
Social Media Platforms with Character Space Limitations: Presenting 
Risk and Benefit Information for Prescription Drugs and Medical 
Devices.'' This draft guidance responds to, among other things, 
stakeholder requests for specific guidance and describes FDA's current 
thinking on how manufacturers, packers, and distributors (firms) of 
prescription human and animal drugs (drugs) and medical devices for 
human use (devices), including biological products, that choose to 
present benefit information should present both benefit and risk 
information within advertising and promotional labeling of their FDA-
regulated medical products on electronic/digital platforms that are 
associated with character space limitations, specifically on the 
Internet and through social media or other technological venues 
(Internet/social media). The draft guidance represents FDA's current 
thinking on specific aspects of FDA's evolving consideration of social 
media platforms and other Internet-related matters. FDA continues 
actively to review, analyze, and develop approaches to a variety of 
topics related to the labeling and advertising of medical products, 
including the development of this and other guidance addressing the use 
of social media platforms and the Internet.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comments on 
this draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by September 16, 2014.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993-0002; or to 
the Office of Communication, Outreach and Development, Center for 
Biologics Evaluation and Research, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002; 
or to the Office of the Center Director, Guidance and Policy 
Development, Center for Devices and Radiological Health, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver 
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist 
that office in processing your requests. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the draft guidance 
document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: 
    Regarding human prescription drugs: Jean-Ah Kang, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Silver Spring, MD 20993, 301-796-1200.
    Regarding prescription human biological products: Stephen Ripley, 
Center for Biologics Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver 
Spring, MD 20993-0002, 240-402-7911.
    Regarding animal prescription drugs: Dorothy McAdams, Center for 
Veterinary Medicine (HFV-216), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 240-276-9300.
    Regarding medical devices for human use: Deborah Wolf, Center for 
Devices and Radiological Health, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 66, Silver Spring, MD 20993, 301-796-5732.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Internet/Social Media Platforms with Character Space 
Limitations: Presenting Risk and Benefit Information for Prescription 
Drugs and Medical Devices.''
    On November 12 and 13, 2009, FDA held a public hearing entitled 
``Promotion of Food and Drug Administration--Regulated Medical Products 
Using the Internet and Social Media Tools'' to provide an opportunity 
for broad public participation and comment on the following questions 
that relate specifically to promotional issues:
    1. For what online communications are manufacturers, packers, or 
distributors accountable?
    2. How can manufacturers, packers, or distributors fulfill 
regulatory requirements (e.g., fair balance, disclosure of indication 
and risk information, and postmarketing submission requirements) in 
their internet and social media promotion, particularly when using 
tools that are associated with space limitations and tools that allow 
for real-time communications (e.g., microblogs and mobile technology)?
    3. What parameters should apply to the posting of corrective 
information on Web sites controlled by third parties?
    4. When is the use of links appropriate?
    Subsequent to the live testimony heard at the public hearing, FDA 
received 72 comments to the docket.
    Specifically, this draft guidance presents considerations to 
illustrate FDA's thinking on factors that are relevant to the 
communication of benefit and risk information on Internet/social media 
platforms with character space limitations. Examples of Internet/

[[Page 34760]]

social media platforms with character space limitations include online 
microblog messaging (e.g., messages on Twitter or ``tweets,'' which are 
currently limited to 140 character spaces per tweet) and online paid 
search (e.g., sponsored links on search engines such as Google and 
Yahoo, which have limited character spaces as well as other platform-
imposed considerations).
    Please note that this draft guidance does not address promotion via 
product Web sites, Web pages on social media networking platforms 
(e.g., individual product pages on Web sites such as Facebook, Twitter, 
YouTube), and online Web banners as the Agency believes that these 
specific types of Internet/social media platforms do not impose the 
same character space constraints as online microblog messaging and 
online paid search. This draft guidance also does not address 
responsive Web design or other technology-specific layout features that 
may result in product promotion presentations that differ depending on 
the technology used to view them (e.g., desktop computer monitors, 
mobile devices, tablets).
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the Agency's current thinking on presenting 
risk and benefit information for prescription drugs and medical devices 
on Internet/social media platforms with character space limitations. It 
does not create or confer any rights for or on any person and does not 
operate to bind FDA or the public. An alternative approach may be used 
if such approach satisfies the requirements of the applicable statutes 
and regulations.

II. The Paperwork Reduction Act of 1995

    This draft guidance contains information collection provisions that 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520). 
The collections of information in 21 CFR 202.1 and 21 CFR parts 801 and 
809 have been approved under OMB control numbers 0910-0686 and 0910-
0485, respectively. In accordance with the PRA, prior to publication of 
any final guidance document, FDA intends to solicit public comment and 
obtain OMB approval for any information collections recommended in this 
guidance that are new or that would represent material modifications to 
previously approved collections of information found in FDA regulations 
or guidances.

III. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm, http://www.fda.gov/MedicalDevices/deviceregulationandguidance/guidancedocuments/default.htm, or http://www.regulations.gov.

    Dated: June 13, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-14220 Filed 6-17-14; 8:45 am]
BILLING CODE 4160-01-P